AzTrials
AzTrials

Prostate CancerHIFINCT04307056

Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

A study testing Radical Prostatectomy and High Intensity Focused Ultrasound (HIFU) Treatment in people with Prostate Cancer and Ultrasound Therapy, run by Association Francaise d'Urologie at 49 sites in 2 countries.

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

to compare the efficacy of HIFU treatment with standard treatment in two situations: 1. as first-line cancer treatment, HIFU is compared to radical prostatectomy. 2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy. Read more about this study

Who is it for?
Ages 70 years and older, men only
Conditions the study is for
Prostate Cancer, Ultrasound Therapy
What is being tested?
Radical Prostatectomy and High Intensity Focused Ultrasound (HIFU) Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,862 participants
Where
49 sitesin 2 countries
Study dates
23 Mar 2015to 24 Aug 2022
Phase
Interventional
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 70 years and older
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients 70 years of age or older
  • Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years
  • Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.
  • NON-INCLUSION CRITERIA
  • Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
  • Included patient simultaneously participating in another research study

Who cannot join

None listed.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

France48 sites

  • Centre Hospitalier d'Aix en Provence

    Aix-en-Provence, 13616

  • Polyckinique du Beaujolais

    Arnas, 69400

  • Clinique St Etienne

    Bayonne, 64100

  • CHRU de Besançon

    Besançon, 25000

  • Clinique St Vincent

    Besançon, 25044

  • Clinique Tivoli-Ducos

    Bordeaux, 33000

  • Clinique St Augustin

    Bordeaux, 33074

  • CHU de Bordeaux

    Bordeaux, 33076

  • Nouvelle clinique Bel Air

    Bordeaux, 33200

  • CHR de Chambéry

    Chambéry, 73011

  • Pôle Santé Léonard de Vinci

    Chambray-lès-Tours, 37170

  • PôleSanté République

    Clermont-Ferrand, 63050

  • Hôpitaux civils de Colmar

    Colmar, 68024

  • Polyclinique du parc Drevon

    Dijon, 21000

  • CHU de Dijon

    Dijon, 21079

  • Cliniqe du Val d'Ouest

    Écully, 69130

  • CHU de Grenoble

    Grenoble, 38043

  • Hôpital Privé Drome Ardèche

    Guilherand-Granges, 07500

  • Cliique du Pré

    Le Mans, 72018

  • Clinique Bon Secours

    Le Puy-en-Velay, 43000

  • CHRU de Lille

    Lille, 59037

  • Clinique La Louvière

    Lille, 59042

  • CHU de Limoges

    Limoges, 87042

  • Hospices Civils de lyon

    Lyon, 69002

  • Hôpital St Joseph

    Marseille, 13008

  • AP-AM

    Marseille, 13015

  • Clinique Beau Soleil

    Montpellier, 34070

  • Clinique Diaconat-Roosevelt

    Mulhouse, 68100

  • CHU de Nice

    Nice, 06200

  • CHU de Nîmes

    Nîmes, 30029

  • Fondation St Jean de Dieu - Clinique Oudinot

    Paris, 75007

  • Clinique Turin

    Paris, 75008

  • Hôpital St Joseph

    Paris, 75014

  • Hôpital TENON

    Paris, 75020

  • Institut Mutualiste Montsouris

    Paris, 75674

  • Hôpital Europeen Georges Pompidou

    Paris, 75908

  • CH de pontoise

    Pontoise, 95300

  • Clinique Courlancy

    Reims, 51100

  • CHU de rennes

    Rennes, 35033

  • Clinique Nantes Atlantis

    Saint-Herblain, 44800

  • CH de Saintonge

    Saintes, 17108

  • Clinique Rhéna

    Strasbourg, 67000

  • Hôpital Foch

    Suresnes, 92150

  • Clinique St Michel

    Toulon, 83000

  • CHU de Toulouse

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, 31076

  • Clinique St Jean du Languedoc

    Toulouse, 31400

  • Clinique Océanne

    Vannes, 56000

Other trials in France

Guadeloupe1 site

  • CHU de guadeloupe

    Pointe-à-Pitre, 97159

Other trials in Guadeloupe

About this study

Official title: EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)

to compare the efficacy of HIFU treatment with standard treatment in two situations:

  1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
  2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
Being tested
Radical Prostatectomy, High Intensity Focused Ultrasound (HIFU) Treatment
Keywords
HIFU
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Radical ProstatectomyProcedure or surgery

    The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA > 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.

  • High Intensity Focused Ultrasound (HIFU) TreatmentProcedure or surgery

    The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.

Study groups in NCT04307056
Study groupRoleWhat they receive
HIFUExperimentalPatients Treated with high intensity focused ultrasound (HIFU)
Receives: Procedure: High Intensity Focused Ultrasound (HIFU) Treatment
ProstatectomyActive comparatorPatients Treated by Radical Prostatectomy
Receives: Procedure: Radical Prostatectomy

What is being measured

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

  1. Recurrence-free survival

    The main objective for patients is to compare recurrence-free survival (i.e., the rate of salvage therapy by external beam radiotherapy and/or hormone therapy) in patients treated by HIFU and those treated by radical prostatectomy. The implementation of salvage therapy will be decided according to several non-exclusive criteria (positivity of margins (for patients with radical prostatectomy), PSA at 3 months, biologic recurrence (increase in PSA > 0.2 ng/ml after radical surgery, > Nadir +2 after HIFU), control biopsies positive, the appearance of metastases

    Measured: 30 months

Secondary outcomes (61)

  1. Immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 6 weeks after treatment

  2. Immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: Day 0, Inclusion

  3. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 3 months after treatment

  4. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 6 months after treatment

  5. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 12 months after treatment

  6. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 18 months after treatment

  7. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 24 months after treatment

  8. immediate or late complications

    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

    Measured: 30 months after treatment

  9. urinary function

    measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort

    Measured: Day 0, Inclusion

  10. urinary function

    measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort

    Measured: 6 months after treatment

  11. urinary function

    measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort

    Measured: 12 months after treatment

  12. urinary function

    measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort

    Measured: 24 months after treatment

  13. urinary function

    measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort

    Measured: 30 months after treatment

  14. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: Day 0, Inclusion

  15. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: 6 months after treatment

  16. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: 12 months after treatment

  17. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: 18 months after treatment

  18. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: 24 months after treatment

  19. urinary function

    Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)

    Translated with www.DeepL.com/Translator (free version)

    Measured: 30 months after treatment

  20. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: Day 0, Inclusion

  21. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: 6 months after treatment

  22. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: 12 months after treatment

  23. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: 18 months after treatment

  24. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: 24 months after treatment

  25. urinary function

    Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:

    stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)

    Measured: 30 months after treatment

  26. sexual fonction

    Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function

    Measured: Day 0, Inclusion

  27. sexual fonction

    Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function

    Measured: 6 months after treatment

  28. sexual fonction

    Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function

    Measured: 12 months after treatment

  29. sexual fonction

    Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function

    Measured: 24 months after treatment

  30. sexual fonction

    Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function

    Measured: 30 months after treatment

  31. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: Day 0, Inclusion

  32. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: 6 months after treatment

  33. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: 12 months after treatment

  34. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: 18 months after treatment

  35. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: 24 months after treatment

  36. Evaluation of quality of life

    Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)

    Measured: 30 months after treatment

  37. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: Day 0, Inclusion

  38. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: 6 months after treatment

  39. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: 12 months after treatment

  40. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: 18 months after treatment

  41. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: 24 months after treatment

  42. Evaluation of quality of life

    Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)

    Measured: 30 months after treatment

  43. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: Day 0, Inclusion

  44. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: 6 months after treatment

  45. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: 12 months after treatment

  46. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: 18 months after treatment

  47. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: 24 months after treatment

  48. Evaluation of quality of life

    Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)

    1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)

    1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)

    1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)

    1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)

    1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)

    Measured: 30 months after treatment

  49. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 6 weeks after treatment

  50. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 3 months after treatment

  51. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 6 months after treatment

  52. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 12 months after treatment

  53. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 18 months after treatment

  54. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 24 months after treatment

  55. The rate of patients in biochemical failure

    The rate of patients in biochemical failure is measured by PSA dosage:

    • PSA > 0.2 ng for patients treated by radical surgery
    • PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU

    Measured: 30 months after treatment

  56. The rate of local recurrence

    The rate of local recurrence is measured by control biopsy (number of positive biopsies)

    Measured: 3 months after treatment

  57. Survival without metastases

    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

    Measured: 6 months after treatment

  58. Survival without metastases

    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

    Measured: 12 months after treatment

  59. Survival without metastases

    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

    Measured: 18 months after treatment

  60. Survival without metastases

    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

    Measured: 24 months after treatment

  61. Survival without metastases

    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

    Measured: 30 months after treatment

Timeline

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

  1. First posted13 Mar 2020
  2. Study start23 Mar 2015
  3. Primary completion24 Aug 2022
  4. Study completion24 Aug 2022

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,862 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307056
Sponsor's protocol ID
HIFU/AFU/12.03
Other IDs
2013-A01042-43
Acronym
HIFI
Status last verified
Nov 2022
First submitted
7 Feb 2020
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ploussard G, Coloby P, Chevallier T, Occean BV, Kassab D, Houede N, Villers A, Rischmann P. Salvage High-intensity Focused Ultrasound for Prostate Cancer Recurrence after Radiotherapy (HIFI-2 Study). Eur Urol Oncol. 2026 Apr 28:S2588-9311(26)00112-4. doi: 10.1016/j.euo.2026.04.007. Online ahead of print.

    PubMed 42055879

  • Ploussard G, Coloby P, Chevallier T, Occean BV, Houede N, Villers A, Rischmann P; HIFI group. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. 2025 May;87(5):526-533. doi: 10.1016/j.eururo.2024.11.006. Epub 2024 Dec 4.

    PubMed 39632125

Questions about this trial

What is this clinical trial studying?

A study testing Radical Prostatectomy and High Intensity Focused Ultrasound (HIFU) Treatment in people with Prostate Cancer and Ultrasound Therapy, run by Association Francaise d'Urologie at 49 sites in 2 countries.

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 6 inclusion and 0 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France, Guadeloupe. 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.

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?

Recurrence-free survival (time frame: 30 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 NCT04307056, which also lists 2 linked publications.

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 12 Jan 2023.

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