Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04307056
Recruitment Status : Active, not recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Association Francaise d'Urologie

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Ultrasound Therapy Procedure: Radical Prostatectomy Procedure: High Intensity Focused Ultrasound (HIFU) Treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4022 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIFU
Patients Treated with high intensity focused ultrasound (HIFU)
Procedure: High Intensity Focused Ultrasound (HIFU) Treatment
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.

Active Comparator: Prostatectomy
Patients Treated by Radical Prostatectomy
Procedure: Radical Prostatectomy
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.




Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 30 months ]
    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


Secondary Outcome Measures :
  1. Immediate or late complications [ Time Frame: 6 weeks after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  2. Immediate or late complications [ Time Frame: Day 0, Inclusion ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  3. immediate or late complications [ Time Frame: 3 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  4. immediate or late complications [ Time Frame: 6 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  5. immediate or late complications [ Time Frame: 12 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  6. immediate or late complications [ Time Frame: 18 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  7. immediate or late complications [ Time Frame: 24 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  8. immediate or late complications [ Time Frame: 30 months after treatment ]
    clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)

  9. urinary function [ Time Frame: Day 0, Inclusion ]
    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

  10. urinary function [ Time Frame: 6 months after treatment ]
    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

  11. urinary function [ Time Frame: 12 months after treatment ]
    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

  12. urinary function [ Time Frame: 24 months after treatment ]
    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

  13. urinary function [ Time Frame: 30 months after treatment ]
    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

  14. urinary function [ Time Frame: Day 0, Inclusion ]

    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)


  15. urinary function [ Time Frame: 6 months after treatment ]

    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)


  16. urinary function [ Time Frame: 12 months after treatment ]

    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)


  17. urinary function [ Time Frame: 18 months after treatment ]

    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)


  18. urinary function [ Time Frame: 24 months after treatment ]

    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)


  19. urinary function [ Time Frame: 30 months after treatment ]

    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)


  20. urinary function [ Time Frame: Day 0, Inclusion ]

    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)


  21. urinary function [ Time Frame: 6 months after treatment ]

    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)


  22. urinary function [ Time Frame: 12 months after treatment ]

    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)


  23. urinary function [ Time Frame: 18 months after treatment ]

    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)


  24. urinary function [ Time Frame: 24 months after treatment ]

    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)


  25. urinary function [ Time Frame: 30 months after treatment ]

    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)


  26. sexual fonction [ Time Frame: Day 0, Inclusion ]
    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

  27. sexual fonction [ Time Frame: 6 months after treatment ]
    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

  28. sexual fonction [ Time Frame: 12 months after treatment ]
    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

  29. sexual fonction [ Time Frame: 24 months after treatment ]
    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

  30. sexual fonction [ Time Frame: 30 months after treatment ]
    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

  31. Evaluation of quality of life [ Time Frame: Day 0, Inclusion ]
    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)

  32. Evaluation of quality of life [ Time Frame: 6 months after treatment ]
    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)

  33. Evaluation of quality of life [ Time Frame: 12 months after treatment ]
    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)

  34. Evaluation of quality of life [ Time Frame: 18 months after treatment ]
    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)

  35. Evaluation of quality of life [ Time Frame: 24 months after treatment ]
    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)

  36. Evaluation of quality of life [ Time Frame: 30 months after treatment ]
    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)

  37. Evaluation of quality of life [ Time Frame: Day 0, Inclusion ]
    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)

  38. Evaluation of quality of life [ Time Frame: 6 months after treatment ]
    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)

  39. Evaluation of quality of life [ Time Frame: 12 months after treatment ]
    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)

  40. Evaluation of quality of life [ Time Frame: 18 months after treatment ]
    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)

  41. Evaluation of quality of life [ Time Frame: 24 months after treatment ]
    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)

  42. Evaluation of quality of life [ Time Frame: 30 months after treatment ]
    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)

  43. Evaluation of quality of life [ Time Frame: Day 0, Inclusion ]

    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)


  44. Evaluation of quality of life [ Time Frame: 6 months after treatment ]

    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)


  45. Evaluation of quality of life [ Time Frame: 12 months after treatment ]

    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)


  46. Evaluation of quality of life [ Time Frame: 18 months after treatment ]

    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)


  47. Evaluation of quality of life [ Time Frame: 24 months after treatment ]

    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)


  48. Evaluation of quality of life [ Time Frame: 30 months after treatment ]

    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)


  49. The rate of patients in biochemical failure [ Time Frame: 6 weeks after treatment ]

    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

  50. The rate of patients in biochemical failure [ Time Frame: 3 months after treatment ]

    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

  51. The rate of patients in biochemical failure [ Time Frame: 6 months after treatment ]

    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

  52. The rate of patients in biochemical failure [ Time Frame: 12 months after treatment ]

    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

  53. The rate of patients in biochemical failure [ Time Frame: 18 months after treatment ]

    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

  54. The rate of patients in biochemical failure [ Time Frame: 24 months after treatment ]

    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

  55. The rate of patients in biochemical failure [ Time Frame: 30 months after treatment ]

    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

  56. The rate of local recurrence [ Time Frame: 3 months after treatment ]
    The rate of local recurrence is measured by control biopsy (number of positive biopsies)

  57. Survival without metastases [ Time Frame: 6 months after treatment ]
    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

  58. Survival without metastases [ Time Frame: 12 months after treatment ]
    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

  59. Survival without metastases [ Time Frame: 18 months after treatment ]
    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

  60. Survival without metastases [ Time Frame: 24 months after treatment ]
    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.

  61. Survival without metastases [ Time Frame: 30 months after treatment ]
    demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

General inclusion criteria

  • Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
  • classified as low or intermediate risk
  • Patient with PSA < 15 ng/ml, Gleason score ≤ 7 restricted to the form [3 + 4].
  • Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
  • Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA > 10 ng/ml
  • Patient affiliated with health insurance or beneficiary of an equivalent plan

Inclusion criteria for the HIFU Arm

  • 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

Inclusion Criteria for Total Prostatectomy Arm

• 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307056


Locations
Show Show 49 study locations
Sponsors and Collaborators
Association Francaise d'Urologie

Layout table for additonal information
Responsible Party: Association Francaise d'Urologie
ClinicalTrials.gov Identifier: NCT04307056    
Other Study ID Numbers: HIFU/AFU/12.03
2013-A01042-43 ( Other Identifier: ANSM )
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Francaise d'Urologie:
HIFU
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes