Clinical trial NCT03668652: Focal Prostate Ablation Versus Radical Prostatectomy
Official title: A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
HIFU and TULSA Focal Treatment
Radical prostatectomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-09-12
Enrollment: 213
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment failure.
timeFrame: At 36 months from the treatment date.
Secondary outcomes:
measure: Focal ablation failure.
timeFrame: Within 36 months from the treatment date.
measure: Total re-ablation rate
timeFrame: Within 36 months from the treatment date.
measure: Diagnostic failure.
timeFrame: Within 36 months from the treatment date.
measure: Cancer specific and all-cause mortality.
timeFrame: Within 36 months from the treatment date.
measure: Difference in metastasis-free and overall survival.
timeFrame: Within 36 months years from the treatment date.
measure: Difference in urinary continence between focal ablation and radical prostatectomy.
timeFrame: Within 36 months from the treatment date.
measure: Difference in erectile function between focal ablation and radical prostatectomy.
timeFrame: Within 36 months from the treatment date.
measure: Difference in quality of life between focal ablation and radical prostatectomy.
timeFrame: Within 36 months from the treatment date.
measure: Difference in adverse events related to both treatments.
timeFrame: Within 36 months from the treatment date
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet
Study officials:
affiliation: Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet
name: Eduard Baco, MD, PhD, Prof. assoc.
role: PRINCIPAL_INVESTIGATOR
References: