Prostate CancerFARPNCT03668652
Focal Prostate Ablation Versus Radical Prostatectomy
A study testing Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) and Radical prostatectomy in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study aims to compare the treatment results of HIFU and Radical prostatectomy. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) and Radical prostatectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteNorway
- Study dates
- 30 Sep 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet
Oslo, 0514
About this study
Official title: A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
This study aims to compare the treatment results of HIFU and Radical prostatectomy.
Read the 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
- Prostate Cancer
- Being tested
- Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical), Radical prostatectomy
- Keywords
- Prostate Cancer, HIFU and TULSA Focal Treatment, Radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)Device
HIFU arm:
Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO
Radical prostatectomyProcedure or surgery
Prostatectomy arm:
Robot assisted or open retropubic prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Focal prostate cancer treatment by HIFU | Experimental | 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 localized > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO device. Receives: Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) |
| Radical Prostatectomy | Active comparator | 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. Receives: Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure.
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.
Measured: At 36 months from the treatment date.
Secondary outcomes (9)
Focal ablation failure.
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.
Measured: Within 36 months from the treatment date.
Total re-ablation rate
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.
Measured: Within 36 months from the treatment date.
Diagnostic failure.
Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area.
Measured: Within 36 months from the treatment date.
Cancer specific and all-cause mortality.
Cause of the mortality will be evaluated and registered.
Measured: Within 36 months from the treatment date.
Difference in metastasis-free and overall survival.
Whole body MRI or PET CT will be performed if suspicion on metastases.
Measured: Within 36 months years from the treatment date.
Difference in urinary continence between focal ablation and radical prostatectomy.
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).
Measured: Within 36 months from the treatment date.
Difference in erectile function between focal ablation and radical prostatectomy.
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.
Measured: Within 36 months from the treatment date.
Difference in quality of life between focal ablation and radical prostatectomy.
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.
Measured: Within 36 months from the treatment date.
Difference in adverse events related to both treatments.
All adverse events will be registered prospectively according to Clavien-Dindo classification.
Measured: Within 36 months from the treatment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start30 Sep 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Eduard Baco, Oslo University Hospital
- Investigators
- Eduard Baco, MD, PhD, Prof. assoc., Principal investigator, Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668652
- Sponsor's protocol ID
- 2017/703
- Acronym
- FARP
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2018
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated during this study will be evaluated at Oslo University Hospital
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03668652
- Acronym / sponsor ID
- FARP / 2017/703
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, HIFU and TULSA Focal Treatment, Radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Focal prostate cancer treatment by HIFU | Experimental | Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)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 localized > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO device. |
| Radical Prostatectomy | Active comparator | Procedure: Radical prostatectomyRobot 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Focal prostate cancer treatment by HIFU |
| Radical prostatectomyProstatectomy arm: Robot assisted or open retropubic prostatectomy | Procedure or surgery | Radical Prostatectomy |
Primary outcome
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.
9 secondary outcomes
Focal ablation failure.
Time frame: Within 36 months from the treatment date.
Total re-ablation rate
Time frame: Within 36 months from the treatment date.
Diagnostic failure.
Time frame: Within 36 months from the treatment date.
Cancer specific and all-cause mortality.
Time frame: Within 36 months from the treatment date.
Difference in metastasis-free and overall survival.
Time frame: Within 36 months years from the treatment date.
Difference in urinary continence between focal ablation and radical prostatectomy.
Time frame: Within 36 months from the treatment date.
Difference in erectile function between focal ablation and radical prostatectomy.
Time frame: Within 36 months from the treatment date.
Difference in quality of life between focal ablation and radical prostatectomy.
Time frame: Within 36 months from the treatment date.
Difference in adverse events related to both treatments.
Time frame: Within 36 months from the treatment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. All data generated during this study will be evaluated at Oslo University Hospital
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Baco, MD, PhD, Prof. assoc. principal investigator
Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) and Radical prostatectomy in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure. (time frame: At 36 months from the treatment date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.