Prostate Cancer
Conditions
Keywords
Prostate Cancer, HIFU and TULSA Focal Treatment, Radical prostatectomy
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.
Interventions
DEVICEFocal 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
PROCEDURERadical prostatectomy
Prostatectomy arm: Robot assisted or open retropubic prostatectomy
Sponsors
University of Oslo
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure. | 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
| Measure | Time frame | Description |
|---|---|---|
| Total re-ablation rate | Within 36 months from the treatment date. | Secondary HIFU ablation was allowed if control biopsies revealed prostate cancer ISUP 1 ( \> 5 mm) and/or ISUP 2-3) in treated or untreated areas. |
| Diagnostic failure. | Within 36 months from the treatment date. | Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area. |
| Cancer specific and all-cause mortality. | Within 36 months from the treatment date. | Cause of the mortality will be evaluated and registered. |
| Difference in metastasis-free and overall survival. | Within 36 months years from the treatment date. | Whole body MRI or PET CT will be performed if suspicion on metastases. |
| Focal ablation failure. | Within 36 months from the treatment date. | Focal ablation failure is classified as presence of Pca ISUP 1 ( \> 5 mm) and/or ISUP 2-3 (any length) on follow up biopsies of the treated prostate zone. |
| Difference in erectile function between focal ablation and radical prostatectomy. | 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. |
| Difference in quality of life between focal ablation and radical prostatectomy. | 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. |
| Difference in adverse events related to both treatments. | Within 36 months from the treatment date | All adverse events will be registered prospectively according to Clavien-Dindo classification. |
| Difference in urinary continence between focal ablation and radical prostatectomy. | Within 36 months from the treatment date. | Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used. Difference in pad free urinary continence and difference in number of pads needed per day. Difference in urinary incontinens defined as (full continence= 0 pads/day; security pad or mild incontinence = 1pad/day; moderate incontinence = 2pads/day and severe incontinence \> 2pads/day). |
Countries
Norway
Outcome results
None listed