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Completed

NCT Number: NCT04307056

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Ultrasound Therapy Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Aix en Provence, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radical prostatectomy

Procedure

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) Treatment

Procedure

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Association Francaise d'Urologie

Other

Registry information

Official study 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)

Acronym: HIFI

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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