Trials / Completed
CompletedNCT03668652
Focal Prostate Ablation Versus Radical Prostatectomy
A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- Male
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to compare the treatment results of HIFU and Radical prostatectomy.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) | HIFU arm: Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO |
| PROCEDURE | Radical prostatectomy | Prostatectomy arm: Robot assisted or open retropubic prostatectomy |
Timeline
- Start date
- 2017-09-30
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2018-09-12
- Last updated
- 2025-04-03
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT03668652. Inclusion in this directory is not an endorsement.