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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
HIFU arm: Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO
Prostatectomy arm: Robot assisted or open retropubic prostatectomy
Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet
Oslo, Norway
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.
Time frame: At 36 months from the treatment date.
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.
Time frame: Within 36 months from the treatment date.
Total re-ablation rate
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.
Time frame: Within 36 months from the treatment date.
Diagnostic failure.
Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area.
Time frame: Within 36 months from the treatment date.
Cancer specific and all-cause mortality.
Cause of the mortality will be evaluated and registered.
Time frame: 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.
Time frame: Within 36 months years from the treatment date.
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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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 36 months from the treatment date