Focal Prostate Ablation Versus Radical Prostatectomy (FARP)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, HIFU Focal Treatment, Radical prostatectomy
Eligibility Criteria
Inclusion Criteria:
- PSA ≤ 20 ng/ml
- Initial diagnosis of localized prostate cancer (stage ≤ T2b)
- Biopsy proven unilateral prostate cancer Gleason score 3+3 and not eligible to active surveillance program [cancer invades over a length of at least 5 mm and MRI demonstrates cancer suspicious lesion score ESUR ≥ 4/5 localized in line with the biopsy AND/OR Gleason score 3+4 (without length criteria of positive biopsies or tumor volume on MRI)
- Patients may have biopsy verified clinically insignificant prostate cancer on the contra-lateral prostate lobe (Gleason score 3+3, maximal cancer core length < 5 mm, MRI score ESUR ≤ 3)
Exclusion Criteria:
- Clinical stage T3
- Metastatic lymph node on MRI or CT
- Patients already treated for Pca (hormone therapy, EBRT)
- Patients with contra-indications to MRI
- Patients with inflammatory bowel disease or 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
Sites / Locations
- Department of Urology Aker, Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Focal prostate cancer treatment by HIFU
Radical Prostatectomy
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.
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.