Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy FailurePhase 2NCT00308919
Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy
A Phase 2 study testing WST09 in people with Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure, run by STEBA France at 1 site in Canada.
Trial summary
To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using different light doses and multiple illuminating fibres. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
- What is being tested?
- WST09
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Nov 2005
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria: 18 years of age or older
Ability to understand the patient's information sheet and to give written informed consent
Histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy
Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease
Recent (within 90 days) CT scan of the abdomen and pelvis and radionucleotide bone scan or equivalent radiographic imaging confirming that no disease is outside of the prostate
Recent (within 3 months) cystoscopy if clinically warranted
Serum prostatic specific antigen (PSA) equal to or less than 20 ng/mL
Serum PSA showing two consecutive increases at least 2 weeks apart
Life expectancy more than 5 years, based on co-morbidity not related to prostate cancer
Ability to comply with the requirements of the study
- Exclusion Criteria: Patients who are currently receiving any hormone treatment for prostatic carcinoma or for any other cancer, or have done so within the last 6 months.
Patients who have received or are receiving chemotherapy for prostatic carcinoma or for any other cancer
Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
Patients who have received a TURP (trans-urethral resection of the prostate)
Patients whose radiation therapy caused extensive cystitis and/or proctitis
Any condition, or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)
History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires
Participation in a clinical study or receipt of an investigational treatment within the past 90 days
A history of porphyria
A history of significant allergies, particularly to Cremophor® and Benadryl®
A history of sun hypersensitivity or photosensitive dermatitis
Renal disorders (blood creatinine > 1.5 x ULN)
Hepatic disorders (transaminases > ULN, bilirubin> ULN)
Hematological disorders: (White cells < 2500/mm3, neutrophil< 1500/mm3, platelets <140,000/mm3, Hb < 8 g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Photodynamic Therapy With WST-09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure : Effect of the Light Dose and the Number of Fibres
To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using different light doses and multiple illuminating fibres.
Read the detailed description
Prostate cancer is a leading cause of morbidity and mortality in men around the world. Because of the worldwide increase in life expectancy, a dramatic increase in the number of patients with prostate cancer is expected. It has been estimated that by the year 2002, 92,000 men over 65 years of age were diagnosed annually in the European community, where prostate cancer will account for 12% of all new male cancer diagnoses.
Consequently, radiation therapy is used extensively for primary therapy of prostatic carcinoma. The Management Report of clinically localized prostate cancer by the National Cancer Institute SEER program indicated that 30% of patients choose radiation therapy as their first treatment option. However, the ability of radiation therapy to totally and permanently eradicate prostatic cancer has come under question recently as a result of the high number of patients who have post radiotherapy elevated prostatic specific antigen (PSA) determinations (85%), and the high positive post irradiation biopsy rate (31 90%). With high local recurrence rates possibly influencing death rates, the recurrence of prostate cancer after potentially curative local therapy is becoming a significant urological problem. As patients are being treated for prostate cancer at a younger age, a significant number of them will ultimately fail the primary treatment and will be candidates for safe and potentially curative salvage therapy.
High complication and morbidity rates associated with current salvage therapies demand new and improved means for eradicating recurrent local disease. Photodynamic therapy, which allows the destruction of a tumor by the IV administration of a photosensitizer and the local application of light, may provide such means. Transperineal interstitial photodynamic therapy is a minimally invasive procedure to treat selected patients with failed radiation therapy of prostate cancer. A preliminary phase 1 study using the photosensitizer meso-tetrahydroxyphenyl chlorine (mTHPC) in 14 patients indicated that PDT could produce necrosis in prostate involving cancers recurring after radiotherapy, with a low incidence of complications.
- Conditions
- Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
- Being tested
- WST09
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST09Drug
Treatment with WST09 Vascular Photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| WST 09 | Experimental | Treatment with WST09 Vascular Photodynamic therapy Receives: Drug: WST09 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startApr 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- STEBA France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Investigators
- John Trachtenberg, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308919
- Sponsor's protocol ID
- HEC/WST03 658 N/WST 2.08
- Status last verified
- May 2010
- First submitted
- 28 Mar 2006
- Last updated
- 22 Jun 2010
- Results posted
- No
Publications
Haider MA, Davidson SR, Kale AV, Weersink RA, Evans AJ, Toi A, Gertner MR, Bogaards A, Wilson BC, Chin JL, Elhilali M, Trachtenberg J. Prostate gland: MR imaging appearance after vascular targeted photodynamic therapy with palladium-bacteriopheophorbide. Radiology. 2007 Jul;244(1):196-204. doi: 10.1148/radiol.2441060398. Epub 2007 May 16.
PubMed 17507719
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Photodynamic Therapy With WST-09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure : Effect of the Light Dose and the Number of Fibres
- ClinicalTrials.gov ID
- NCT00308919
- Acronym / sponsor ID
- HEC/WST03 658 N/WST 2.08
- Conditions
- Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- STEBA FranceIndustry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Study start
- Apr 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 30 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using different light doses and multiple illuminating fibres.
Detailed description
Prostate cancer is a leading cause of morbidity and mortality in men around the world. Because of the worldwide increase in life expectancy, a dramatic increase in the number of patients with prostate cancer is expected. It has been estimated that by the year 2002, 92,000 men over 65 years of age were diagnosed annually in the European community, where prostate cancer will account for 12% of all new male cancer diagnoses.
Consequently, radiation therapy is used extensively for primary therapy of prostatic carcinoma. The Management Report of clinically localized prostate cancer by the National Cancer Institute SEER program indicated that 30% of patients choose radiation therapy as their first treatment option. However, the ability of radiation therapy to totally and permanently eradicate prostatic cancer has come under question recently as a result of the high number of patients who have post radiotherapy elevated prostatic specific antigen (PSA) determinations (85%), and the high positive post irradiation biopsy rate (31 90%). With high local recurrence rates possibly influencing death rates, the recurrence of prostate cancer after potentially curative local therapy is becoming a significant urological problem. As patients are being treated for prostate cancer at a younger age, a significant number of them will ultimately fail the primary treatment and will be candidates for safe and potentially curative salvage therapy.
High complication and morbidity rates associated with current salvage therapies demand new and improved means for eradicating recurrent local disease. Photodynamic therapy, which allows the destruction of a tumor by the IV administration of a photosensitizer and the local application of light, may provide such means. Transperineal interstitial photodynamic therapy is a minimally invasive procedure to treat selected patients with failed radiation therapy of prostate cancer. A preliminary phase 1 study using the photosensitizer meso-tetrahydroxyphenyl chlorine (mTHPC) in 14 patients indicated that PDT could produce necrosis in prostate involving cancers recurring after radiotherapy, with a low incidence of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST 09 | Experimental | Drug: WST09Treatment with WST09 Vascular Photodynamic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST09Treatment with WST09 Vascular Photodynamic therapy | Drug | WST 09 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 17507719Haider MA, Davidson SR, Kale AV, Weersink RA, Evans AJ, Toi A, Gertner MR, Bogaards A, Wilson BC, Chin JL, Elhilali M, Trachtenberg J. Prostate gland: MR imaging appearance after vascular targeted photodynamic therapy with palladium-bacteriopheophorbide. Radiology. 2007 Jul;244(1):196-204. doi: 10.1148/radiol.2441060398. Epub 2007 May 16.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Trachtenberg, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WST09 in people with Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure, run by STEBA France at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Jun 2010. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308919, which also lists 1 linked publication.
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 22 Jun 2010; AzTrials last refreshed its copy on 26 Oct 2026.