A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 213
- Locations
- 2
- Primary Endpoint
- Treatment failure.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive MRI (PIRAD 3-5) and biopsy proven unilateral prostate cancer classified as ISUP 1 (with cancer core length > 5mm) or ISUP 2-3 (any length) not eligible to active surveillance or watchful waiting
- •PSA ≤ 20 ng/ml
- •Treatment naive patients with localized prostate cancer (stage ≤ T2b)
Exclusion Criteria
- •Clinical stage T> 2b
- •Metastatic lymph node on imaging
- •Patients already treated for Pca (hormone therapy, EBRT)
- •Patients with contra-indications to MRI
- •Patients with active inflammatory bowel disease or previous rectal fistula
- •History of previous pelvic radiotherapy
- •History of bladder cancer
- •History of bladder neck or urethral stricture
- •Urogenital infection in progress
- •Allergy to latex or gadolinium
- •Patients on life support or suffering form unstable neurological diseases
Outcomes
Primary Outcomes
Treatment failure.
Time Frame: At 36 months from the treatment date.
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.
Secondary Outcomes
- Difference in erectile function between focal ablation and radical prostatectomy.(Within 36 months from the treatment date.)
- Focal ablation failure.(Within 36 months from the treatment date.)
- Total re-ablation rate(Within 36 months from the treatment date.)
- Diagnostic failure.(Within 36 months from the treatment date.)
- Cancer specific and all-cause mortality.(Within 36 months from the treatment date.)
- Difference in metastasis-free and overall survival.(Within 36 months years from the treatment date.)
- Difference in urinary continence between focal ablation and radical prostatectomy.(Within 36 months from the treatment date.)
- Difference in quality of life between focal ablation and radical prostatectomy.(Within 36 months from the treatment date.)
- Difference in adverse events related to both treatments.(Within 36 months from the treatment date)
Investigators
Eduard Baco
Principal Investigator
Oslo University Hospital