Focal Prostate Ablation Versus Radical Prostatectomy (FARP)
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|ClinicalTrials.gov Identifier: NCT03668652|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Focal HIFU treatment using Focal One (EDAP TMS) 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, 2019|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Focal prostate cancer treatment by HIFU
Focal HIFU treatment using Focal One (EDAP TMS) device will be applied to the prostate region where MRI and 3D-TRUS registered prostate biopsy detected clinically significant prostate cancer. Treatment efficacy will be per-operatively controlled using dynamic contrast enhanced ultrasound. If like non-necrotic area within the treatment zone will be identified, additional HIFU treatment limited to sub-optimally treated regions will be performed during the same intervention.
Device: Focal HIFU treatment using Focal One (EDAP TMS)
Focal ablation of prostate cancer using HIFU Focal One
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. ]EPIC-26 questionnaire for the evaluation of continence will be used.
- To compare erectile function between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]IIEF-5 questionnaire for the evaluation erectil function will be used.
- To compare quality of life between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]EORTC QLQ-C30 questionnaire 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|