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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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This study aims to compare the treatment results of HIFU and Radical prostatectomy.
The FARP randomized control study will compare focal ablation of prostate using High Intensity Focused Ultrasound (HIFU) applied by FocalOne® or TULSA® device versus Radical Prostatectomy (RP) in patients with unilateral, intermediate risk prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal prostate cancer treatment by HIFU | Experimental | Patients with target lesion distance < 30 mm from the rectum will be treated with High Intensity Focused Ultrasound (HIFU) applied by FocalOne HIFU device and patients with lesion localized > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO device. |
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| Radical Prostatectomy | Active Comparator | Robot assisted laparoscopic radical prostatectomy or open retro-pubic radical prostatectomy will be performed using validated radical prostatectomy technique. Nerve sparing surgery on side of cancer free prostate lobe will be performed and type of nerve sparing procedure will be specified. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) | Device | HIFU arm: Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure. | Treatment failure in focal ablation arm is classified as the need for secondary whole gland treatment such as radical prostatectomy or EBRT due to detection of ISUP > 3 in treated and/or untreated areas on follow up prostate biopsy, or development of metastases on imaging. Treatment failure in the radical prostatectomy arm is classified as PSA > 0.2 ng/ml after surgery. | At 36 months from the treatment date. |
| Measure | Description | Time Frame |
|---|---|---|
| Focal ablation failure. | Focal ablation failure is classified as presence of Pca ISUP 1 ( > 5 mm) and/or ISUP 2-3 (any length) on follow up biopsies of the treated prostate zone. | Within 36 months from the treatment date. |
| Total re-ablation rate |
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Inclusion Criteria:
Exclusion Criteria:
Males
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| Name | Affiliation | Role |
|---|---|---|
| Eduard Baco, MD, PhD, Prof. assoc. | Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet | Oslo | 0514 | Norway |
All data generated during this study will be evaluated at Oslo University Hospital
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized controlled trial.
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Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.
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| Radical prostatectomy | Procedure | Prostatectomy arm: Robot assisted or open retropubic prostatectomy |
|
Secondary HIFU ablation was allowed if control biopsies revealed prostate cancer ISUP 1 ( > 5 mm) and/or ISUP 2-3) in treated or untreated areas.
| Within 36 months from the treatment date. |
| Diagnostic failure. | Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area. | Within 36 months from the treatment date. |
| Cancer specific and all-cause mortality. | Cause of the mortality will be evaluated and registered. | Within 36 months from the treatment date. |
| Difference in metastasis-free and overall survival. | Whole body MRI or PET CT will be performed if suspicion on metastases. | Within 36 months years from the treatment date. |
| Difference in urinary continence between focal ablation and radical prostatectomy. | Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used. Difference in pad free urinary continence and difference in number of pads needed per day. Difference in urinary incontinens defined as (full continence= 0 pads/day; security pad or mild incontinence = 1pad/day; moderate incontinence = 2pads/day and severe incontinence > 2pads/day). | Within 36 months from the treatment date. |
| Difference in erectile function between focal ablation and radical prostatectomy. | International Index of Erectile Function (IIEF-5) questionnaire for the evaluation erectile function will be used. A score of 1-5 is awarded to each of the 5 questions. Change in total score will be measured between the baseline and most recent follow-up visit. | Within 36 months from the treatment date. |
| Difference in quality of life between focal ablation and radical prostatectomy. | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) for the evaluation of quality of life between focal ablation and radical prostatectomy will be used. | Within 36 months from the treatment date. |
| Difference in adverse events related to both treatments. | All adverse events will be registered prospectively according to Clavien-Dindo classification. | Within 36 months from the treatment date |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |