Focal Prostate Ablation Versus Radical Prostatectomy (FARP)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03668652|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) Procedure: Radical prostatectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial.|
|Masking:||None (Open Label)|
|Masking Description:||Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.|
|Official Title:||A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy|
|Actual Study Start Date :||September 30, 2017|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Focal prostate cancer treatment by HIFU
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 > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO.
Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)
Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO
Active Comparator: Radical Prostatectomy
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.
Procedure: Radical prostatectomy
Robot assisted or open retropubic prostatectomy
- Treatment failure. [ Time Frame: At 36 months from the treatment date. ]
Treatment failure in HIFU focal ablation arm is classified as the need for secondary whole gland treatment as radical prostatectomy or EBRT.
Treatment failure in radical prostatectomy arm is classified as PSA > 0.2 and need for EBRT.
- To compare urinary continence between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]
Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used.
Variation in urinary continence according to the number of pads used/day due to continence problems compared to baseline.
Categories are defined as (full continence= 0 pads/day; security pad or mild incontinence =1pad/day; moderate incontinence= 2pads/day and severe incontinence >2pads/day).
- To compare erectile function between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]
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.
- To compare quality of life between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]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.
- Focal ablation failure. [ Time Frame: Within 36 months from the treatment date. ]
Focal ablation failure is classified as presence of clinically significant cancer on control MRI-3D TRUS image fusion guided biopsy in the treated prostate zone.
At least 2 targeted biopsy cores will be localized in the treatment zone. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
- To compare short, medium and long term adverse events related to treatments. [ Time Frame: Within 36 months from the treatment date ]All adverse events will be registered prospectively.
- Diagnostic failure. [ Time Frame: Within 36 months from the treatment date. ]Diagnostic failure is classified as diagnosis of clinically significant cancer localized outside of treatment zone in treated lobe and in any region of non- treated prostate lobe. MRI and systematic radom prostate biopsy form each prostate sextant will be performed and location of each biopsy trajectory will be registered using Trinity (Koelis) device. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
- Cancer progression including development of metastases. [ Time Frame: Within 36 months years from the treatment date. ]Whole body MRI or PET CT will be performed if suspicion on metastases.
- Cancer specific and all-cause mortality. [ Time Frame: Within 36 months from the treatment date. ]Cause of the mortality will be evaluated and registered.
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): NCT03668652
|Contact: Anne Klara Sørbø, nurse||+47 23 03 31 firstname.lastname@example.org|
|Department of Urology Aker, Oslo University Hospital||Recruiting|
|Oslo, Norway, 0514|
|Contact: Eduard Baco, MD, PhD +47 22 89 40 00 Eduard.Baco@medisin.uio.no|
|Principal Investigator:||Eduard Baco, MD, PhD||Department of Urology Aker, Oslo University Hospital|