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Prostate CancerPhase 2FOCALENCT03568188

Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

A Phase 2 study testing treatment with focal HIFU, PSA dosage and MRI in people with Prostate Cancer, run by Hospices Civils de Lyon at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life… Read more about this study

Who is it for?
Ages 50 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
treatment with focal HIFU, PSA dosage and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
14 sitesFrance
Study dates
28 Sep 2018to 9 Feb 2026
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 50 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
  • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
  • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
  • A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
  • Gleason score= 7 (3+4).
  • Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
  • PSA ≤ 15ng / ml.
  • Patient affiliated with health insurance or beneficiary of an equivalent plan.

Who cannot join

  • Contraindications to treatment with HIFU-F:
  • Tumor not accessible.
  • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
  • History of pelvic irradiation
  • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
  • Fistula of the urinary tract or rectum.
Show all 26Show fewer
  • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
  • Anatomical abnormality of the rectum or rectal mucosa.
  • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
  • History of intestinal inflammatory pathology.
  • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
  • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
  • Allergy to latex.
  • Thickness of the rectal wall> 10mm.
  • TURP indication. Bladder neck incision is allowed.
  • Patient with a medical contraindication to Sonovue® injection.
  • Patient with a medical contraindication on MRI.
  • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
  • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
  • History of pelvic radiotherapy.
  • History of sclerosis of the bladder neck or urethral stenosis.
  • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy).
  • Patients with unstable neurological pathology.
  • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
  • Legal person protected by law.
  • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Polyclinique du parc Rambot

    Aix-en-Provence, 13100

  • Clinique Saint-Vincent

    Besançon, 25044

  • Service d'Urologie, Clinique Tivoli Ducos

    Bordeaux, 33000

  • Groupe Hospitalier Pellegrin - CHU

    Bordeaux, 33076

  • Hôpital L. Pasteur, Hôpitaux Civils de Colmar

    Colmar, 68024

  • Service d'Urologie CHRU de Lille, Hôpital HURIEZ

    Lille, 59000

  • Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

    Lille, 59000

  • Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

    Lyon, 69437

  • Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

    Marseille, 13915

  • Département d'Urologie, Institut Montsouris

    Paris, 75014

  • Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

    Pierre-Bénite, 69495

  • Clinique Urologique Nantes Atlantis

    Saint-Herblain, 44800

  • Service d'Urologie, Hôpital Foch

    Suresnes, 92150

  • CHU de Toulouse - Hôpital de Rangueil

    Toulouse, 31400

Other trials in France

About this study

Official title: Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer

The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

Conditions
Prostate Cancer
Being tested
treatment with focal HIFU, PSA dosage, MRI, Questionnaires, Prostatic biopsies
Keywords
prostate cancer, HIFU focal, adverse effect, intermediate risk
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • treatment with focal HIFUProcedure or surgery

    HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.

  • PSA dosageBiological

    PSA dosage will be regularly performed during patient follow up thanks to blood sampling.

  • MRIDevice

    MRI exam will be regularly performed during patient follow up.

  • QuestionnairesOther

    Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function).

  • Prostatic biopsiesProcedure or surgery

    Prostatic biopsies will be regularly performed during patient follow up.

  • blood testBiological

    if the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) will be performed during their follow up.

  • urine testBiological

    if the patient decides to participate in the ancillary study, a urine test (for PCA3 test) will be performed during their follow up.

Study groups in NCT03568188
Study groupRoleWhat they receive
HIFU treatmentExperimental170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
Receives: Procedure: treatment with focal HIFU; Biological: PSA dosage; Device: MRI; Other: Questionnaires; Procedure: Prostatic biopsies; Biological: blood test; Biological: urine test

What is being measured

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

  1. patient proportion with controlled disease (Control of the pathology)

    The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.

    Measured: 12 months

Secondary outcomes (32)

  1. proportion of patients needing additional treatment

    The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 12 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.

    Measured: 12 months

  2. proportion of patients needing additional treatment

    The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 48 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.

    Measured: 48 months

  3. proportion of patients needing additional radical treatment

    The objective is to determine the proportion of patients needing additional radical treatment at 12 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.

    Measured: 12 months

  4. proportion of patients needing additional radical treatment

    The objective is to determine the proportion of patients needing additional radical treatment at 48 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.

    Measured: 48 months

  5. rate of positive biopsies

    The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 12 months.

    Measured: 12 months

  6. rate of positive biopsies

    The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 24 months.

    Measured: 24 months

  7. rate of positive biopsies

    The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 48 months.

    Measured: 48 months

  8. clinically significant cancer rate

    The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the carcinologic evolution at 48 months.

    Measured: 48 months

  9. Gleason score

    Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 12 month.

    The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

    Measured: 12 months

  10. Gleason score

    Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 24 month.

    The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

    Measured: 24 months

  11. Gleason score

    Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 48 month.

    The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

    Measured: 48 months

  12. Appearance of another cancerous focus in the other half of the prostate

    Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

    Measured: 12 months

  13. Appearance of another cancerous focus in the other half of the prostate

    Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

    Measured: 24 months

  14. Appearance of another cancerous focus in the other half of the prostate

    Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

    Measured: 48 months

  15. Appearance of metastases

    Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

    Measured: 12 months

  16. Appearance of metastases

    Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

    Measured: 24 months

  17. Appearance of metastases

    Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

    Measured: 48 months

  18. Appearance of an extra capsular extension

    Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

    Measured: 12 months

  19. Appearance of an extra capsular extension

    Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

    Measured: 24 months

  20. Appearance of an extra capsular extension

    Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

    Measured: 48 months

  21. Overall survival

    Overall survival at 48 months will be measured from the date of inclusion to the date of death, all causes of death combined or the date of last new or point date to 48 months.

    Measured: 48 months

  22. Prostate cancer specific survival

    Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of death related to prostate cancer or the date of last new or point date to 48 months

    Measured: 48 months

  23. Recurrence free survival

    Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of first metastasis , or the date of last new or point date to 48 months.

    Measured: 48 months

  24. Proportion of serious adverse effect

    comparison of the proposition of serious adverse effect at 48 months

    Measured: 48 months

  25. Quality of life score

    quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire.

    It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the better the quality of life.

    Measured: over the 48 months

  26. EPIC-26 score

    urinary function will be assessed using the EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire.

    The EPIC-26 is a self-reported scale health-related quality of life questionnaire for prostate cancer patients . It is composed of 26 items in 4 different domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal.

    Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Each items as a standardized value from 0 to 100. Then the average of the standardized value is determined in each domain to crate the summary score. The higher the score, the better the quality of life.

    Measured: over the 48 months

  27. IPSS score

    urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire.

    The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.

    Measured: over the 48 months

  28. IIEF-5 score

    Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.

    The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).

    The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.

    Measured: over the 48 months

  29. patient proportion with controlled disease (Control of the pathology)

    The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 48 months after inclusion.

    Measured: 48 months

  30. Ancillary study: Measure of anti-tumoral immunity induction

    The consequences of HIFU treatment over immune anti-tumoral induction will be estimated by the description of Programmed death-ligand 1/ligand 2 (PDL1/L2) overexpression on immune cells and overexpression of Programmed cell death 1 (PD-1) on T lymphocytes (T-cells).

    Measured: over the 48 months

  31. Ancillary study: Measure of Circulating Tumor Cells (CTC) number reduction

    The consequences of HIFU treatment over Messenger RNA (mRNA) will be estimated by measure of CTC number reduction.

    Measured: over the 48 months

  32. Ancillary study: Measure of ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level reduction.

    The consequences of HIFU treatment over PCA3 will be estimated by measure of ncRNA PCA3 level reduction.

    Measured: over the 48 months

Timeline

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

  1. First posted26 Jun 2018
  2. Study start28 Sep 2018
  3. Primary completion9 Feb 2026
  4. Study completion9 Feb 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568188
Sponsor's protocol ID
69HCL18_0292
Other IDs
2018-A01171-54
Acronym
FOCALE
Status last verified
Feb 2026
First submitted
6 Jun 2018
Last updated
24 Feb 2026
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 treatment with focal HIFU, PSA dosage and MRI in people with Prostate Cancer, run by Hospices Civils de Lyon at 14 sites 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 26 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: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 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.

What does the primary outcome measure?

patient proportion with controlled disease (Control of the pathology) (time frame: 12 months). 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 NCT03568188.

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 24 Feb 2026.

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