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AzTrials

Prostate CancerPhase 2CAPEMCHARNCT04423913

Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy

A Phase 2 study testing Administration of embolization beads in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy. The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Administration of embolization beads
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFrance
Study dates
4 May 2022to 31 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have given written informed consent.
  • Patients must be affiliated to or benefit from a health insurance scheme.
  • Patients with a high-risk prostate cancer with a Gleason score of 9-10 on the biopsy, candidate for a multimodal treatment with radical prostatectomy validated at the multidisciplinary meeting.
  • Patients with a normal blood count.
  • Patients with a normal liver function test.
  • Patients with an electrocardiogram including left ventricle ejection fraction (ventricular scintigraphy or echocardiography) and an echocardiogram allowing us to rule out heart disease.
  • Patient must be completely recovered from acute toxicities (such as stomatitis, neutropenia, thrombopenia and generalized infections) caused by a previous cytotoxic treatment.
  • OMS/ECOG score≤1 (to guard against a possible loss of therapeutic opportunity related to a delay in surgery caused by chemo-embolization).

Who cannot join

  • Patients who are taking part in another study.
  • Patients in an exclusion period determined by a previous study.
  • Patients under legal guardianship, curatorship or tutorship.
  • Patients not in condition to be able to express his consent (e.g. patient undergoing psychiatric treatment with mental disorders)
  • Patients who refuse to sign the consent form.
  • Patients for whom it is impossible to give clear information. • Patient already has a metastatic disease.
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  • Patients who have contraindications for surgery.
  • Patients with a rectal or vesicular collateral pathology that cannot be excluded or a collateral penile pathology which, by precaution, would not allow embolization (unknown effect on the erection in the event of arterial exclusion).
  • Patients with a contraindication for magnetic resonance imaging (pacemaker incompatible with MRI, claustrophobia, metal apparatus, total hip prosthesis).
  • Patients with a past history of aortobifemoral bypass procedure or other vascular surgery making endovascular access to the prostate arteries impossible.
  • Patients with irreversible hemostasis disorder: TP < 50%, TCA > twice the control, Platelets < 60 G/L.
  • Patients with contraindications as mentioned in the Summary of Product Characteristics for Doxorubicin.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nîmes University Hospital

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study

Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.

The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.

The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).

Conditions
Prostate Cancer
Being tested
Administration of embolization beads
Keywords
doxorubicin, beads, embolization, chemoembolization, prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of embolization beadsOther

    Patients will receive embolization beads, loaded with doxorubicin or not.

Study groups in NCT04423913
Study groupRoleWhat they receive
Patients undergoing transarterial embolization of the prostateExperimentalThree patients will undergo transarterial embolization of the prostate using unloaded beads.
Receives: Other: Administration of embolization beads
Transarterial prostatic chemoembolization, 2.5 mg doxorubicinExperimentalThree patients will undergo transarterial chemoembolization of the prostate using beads loaded with 2.5 mg of doxorubicin.
Receives: Other: Administration of embolization beads
Transarterial prostatic chemoembolization, 5.0 mg doxorubicinExperimentalThree patients will undergo transarterial chemoembolization of the prostate using beads loaded with 5.0 mg of doxorubicin.
Receives: Other: Administration of embolization beads
Transarterial prostatic chemoembolization, 10.0 mg doxorubicinExperimentalThree patients will undergo transarterial chemoembolization of the prostate using beads loaded with 10.0 mg of doxorubicin.
Receives: Other: Administration of embolization beads

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of safety of prostate embolization using unloaded beads.

    The number of serious undesirable events will be noted during the embolization. The undesirable event noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 0 (i.e. on the day of the intervention)

  2. Evaluation of safety of prostate embolization using unloaded beads.

    The number of serious undesirable events will be noted the day after embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 1 (i.e. one day after the intervention)

  3. Evaluation of safety of prostate embolization using unloaded beads.

    The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 5 (i.e. 5 days after the intervention)

  4. Evaluation of safety of prostate embolization using unloaded beads.

    This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 14 (i.e. 2 weeks after the intervention)

  5. Evaluation of safety of prostate embolization using unloaded beads.

    Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 30 (i.e. 1 month after the intervention)

  6. Evaluation of safety of prostate embolization using unloaded beads.

    Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Three months after the intervention

  7. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 0 (i.e. on the day of the intervention)

  8. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    The number of serious undesirable events will be noted after the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 1 (i.e. one day after the intervention)

  9. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 5 (i.e. 5 days after the intervention)

  10. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 14 (i.e. 2 weeks after the intervention)

  11. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 30 (i.e. 1 month after the intervention)

  12. Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Three months after the intervention

  13. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 0 (i.e. on the day of the intervention)

  14. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    The number of serious undesirable events will be noted after the embolization. The side effects noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 1 (i.e. one day after the intervention)

  15. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 5 (i.e. 5 days after the intervention)

  16. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 14 (i.e. 2 weeks after the intervention)

  17. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 30 (i.e. 1 month after the intervention)

  18. Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: 3 months after the intervention

  19. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 0 (i.e. on the day of the intervention)

  20. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    The number of serious undesirable events will be noted after the clinical embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 1 (i.e. one day after the intervention)

  21. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 5 (i.e. 5 days after the intervention)

  22. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 14 (i.e. 2 weeks after the intervention)

  23. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Day 30 (i.e. 1 month after the intervention)

  24. Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin

    Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.

    Measured: Three months after the intervention

Secondary outcomes (81)

  1. Tolerance of prostate embolization using unloaded beads.

    Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.

    Measured: Day 14

  2. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin.

    Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.

    Measured: Day 14

  3. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin.

    Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.

    Measured: Day 14

  4. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin.

    Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.

    Measured: Day 14

  5. Tolerance of prostate embolization using unloaded beads: Clavien-Dindo score

    Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…

    Measured: Day 14

  6. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin:Clavien-Dindo score

    Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…

    Measured: Day 14

  7. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: Clavien-Dindo score

    Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…

    Measured: Day 14

  8. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: Clavien-Dindo score

    Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…

    Measured: Day 14

  9. Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 14

  10. Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 30 (i.e. one month after embolization)

  11. Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Three months after embolization

  12. Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 14

  13. Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 30 (i.e. 1 month after embolization)

  14. Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Three months after embolization

  15. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 14

  16. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 30 i.e. 1 month after embolization

  17. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Three months after embolization

  18. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 14

  19. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Day 30 (i.e. 1 month after embolization)

  20. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score

    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

    Measured: Three months after embolization

  21. Tolerance of prostate embolization using unloaded beads : IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 14

  22. Tolerance of prostate embolization using unloaded beads : IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 30 (i.e. 1 month after embolization)

  23. Tolerance of prostate embolization using unloaded beads : IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Three months after embolization

  24. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 14

  25. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 30 (i.e. one month after embolization)

  26. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Three months after embolization)

  27. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 14

  28. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 30 (i.e. 1 month after embolization)

  29. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Three months after embolization

  30. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 14

  31. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Day 30 (i.e.1 month after embolization)

  32. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score

    The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof \& Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.

    Measured: Three months after embolization

  33. Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 14

  34. Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 30 (i.e. 1 month after embolization)

  35. Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Three months after embolization

  36. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 14

  37. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 30 (i.e. 1 month after embolization)

  38. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Three months after embolization

  39. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 14

  40. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 30 (i.e. 1 month after embolization)

  41. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Three months after embolization

  42. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 14

  43. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Day 30 (i.e. 1 month after embolization)

  44. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score

    The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.

    Measured: Three months after embolization

  45. Tolerance of prostate embolization using unloaded beads : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 14

  46. Tolerance of prostate embolization using unloaded beads : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 30 (i.e. 1 month after embolization)

  47. Tolerance of prostate embolization using unloaded beads : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Three months after embolization

  48. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 14

  49. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 30 (1 month after embolization)

  50. Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Three months after embolization)

  51. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 14

  52. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 30 (i.e. 1 month after embolization)

  53. Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Three months after embolization

  54. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 14

  55. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Day 30 (1 month after embolization)

  56. Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test

    The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.

    Measured: Three months after embolization

  57. Prostate-specific antigen level in patients treated with unloaded beads.

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 14 before surgery

  58. Prostate-specific antigen level in patients treated with unloaded beads.

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 30 (i.e. 1 month after embolization)

  59. Prostate-specific antigen level in patients treated with unloaded beads.

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Three months after embolization

  60. Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 14 before surgery

  61. Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 30 (i.e. 1 month after embolization)

  62. Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Three months after embolization

  63. Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 14 before surgery

  64. Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 30 (i.e. month after embolization)

  65. Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Three months after embolization

  66. Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 14

  67. Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Day 30 (i.e. 1 month after embolization)

  68. Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .

    This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.

    Measured: Three months after embolization

  69. Biological checkup for patients treated with beads loaded with 2.5 mg of doxorubicine

    The following levels will be tested : uric acid, potassium, creatinin, calcium. phosphate)

    Measured: Three months after embolization

  70. Biological checkup for patients treated with beads loaded with 5.0 mg of doxorubicine

    The following levels will be tested : uric acid, potassium, creatinin, calcium.

    Measured: Three months after embolization

  71. Biological checkup for patients treated with beads loaded with 10.0 mg of doxorubicine

    The following levels will be tested : uric acid, potassium, creatinin, calcium.

    Measured: Three months after embolization

  72. Complete blood count for patients treated with beads loaded with 2.5 mg of doxorubicine

    The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.

    Measured: Three months after embolization

  73. Complete blood count for patients treated with beads loaded with 5.0 mg of doxorubicine

    The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.

    Measured: Three months after embolization

  74. Complete blood count for patients treated with beads loaded with 10.0 mg of doxorubicine

    The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.

    Measured: Three months after embolization

  75. Liver test for patients treated with beads loaded with 2.5 mg of doxorubicine

    The following elements will be measured and compared with the test results before treatment :

    • Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
    • bilirubin

    Measured: Three months after embolization

  76. Liver test for patients treated with beads loaded with 5.0 mg of doxorubicine

    The following elements will be measured and compared with the test results before treatment :

    • Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
    • bilirubin

    Measured: Three months after embolization

  77. Liver test for patients treated with beads loaded with 10.0 mg of doxorubicine

    The following elements will be measured and compared with the test results before treatment :

    • Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
    • bilirubin

    Measured: Three months after embolization

  78. Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 2.5 mg of doxorubicine

    The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).

    Measured: Three months after embolization

  79. Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 5.0 mg of doxorubicine

    The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).

    Measured: Three months after embolization

  80. Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 10.0 mg of doxorubicine

    The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).

    Measured: Three months after embolization

  81. Systemic dosage of free doxorubicin in blood in patients treated with beads loaded with 2.5 mg of doxorubicine

    A blood sample will be taken and the concentration of doxorubicin will be measured in mg/m2

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start4 May 2022
  3. Primary completion1 Jun 2022
  4. Study completion31 Oct 2022

Why it stopped: Recruitment difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a purely descriptive, non randomized, non controlled, prospective sequential-type pilot study on the first use in the indication for prostatic arterial embolization using beads loaded with doxorubicin in increasing doses: 0 mg, 2.5mg, 5 mg and 10 mg. It is a study with escalating doses of doxorubicin : 3 patients with non-loaded beads, 3 patients with beads loaded at 2.5 mg (1/20 of the dose administered for liver tumors), 3 patients with beads loaded at 5mg and 3 patients with beads loaded at 10mg.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04423913
Sponsor's protocol ID
NIMAO/2018-01/JF-01
Other IDs
2019-001920-36, 2019-A02946-51, 2019
Acronym
CAPEMCHAR
Status last verified
Mar 2023
First submitted
5 Jun 2020
Last updated
27 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Administration of embolization beads in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of safety of prostate embolization using unloaded beads. (time frame: Day 0 (i.e. on the day of the intervention)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04423913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.

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