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Focal Prostate Ablation Versus Radical Prostatectomy (FARP)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)
Radical prostatectomy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, HIFU Focal Treatment, Radical prostatectomy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Focal prostate cancer treatment by HIFU

Radical Prostatectomy

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment failure.
Treatment failure in HIFU focal ablation arm is classified as the need for secondary whole gland treatment as radical prostatectomy or EBRT. Treatment failure in radical prostatectomy arm is classified as PSA > 0.2 or positive surgical margins and need for EBRT.

Secondary Outcome Measures

To compare 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. Variation in urinary continence according to the number of pads used/day due to continence problems compared to baseline. Categories are defined as (full continence= 0 pads/day; security pad or mild incontinence =1pad/day; moderate incontinence= 2pads/day and severe incontinence >2pads/day).
To compare 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.
To compare 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.
Focal ablation failure.
Focal ablation failure is classified as presence of clinically significant cancer on control MRI-3D TRUS image fusion guided biopsy in the treated prostate zone. At least 2 targeted biopsy cores will be localized in the treatment zone. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
To compare short, medium and long term adverse events related to treatments.
All adverse events will be registered prospectively.
Diagnostic failure.
Diagnostic failure is classified as diagnosis of clinically significant cancer localized outside of treatment zone in treated lobe and in any region of non- treated prostate lobe. MRI and systematic radom prostate biopsy form each prostate sextant will be performed and location of each biopsy trajectory will be registered using Trinity (Koelis) device. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
Cancer progression including development of metastases.
Whole body MRI or PET CT will be performed if suspicion on metastases.
Cancer specific and all-cause mortality.
Cause of the mortality will be evaluated and registered.

Full Information

First Posted
April 15, 2018
Last Updated
March 13, 2021
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03668652
Brief Title
Focal Prostate Ablation Versus Radical Prostatectomy
Acronym
FARP
Official Title
A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, HIFU Focal Treatment, Radical prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
None (Open Label)
Masking Description
Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focal prostate cancer treatment by HIFU
Arm Type
Experimental
Arm Description
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.
Arm Title
Radical Prostatectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)
Intervention Description
HIFU arm: Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO
Intervention Type
Procedure
Intervention Name(s)
Radical prostatectomy
Intervention Description
Prostatectomy arm: Robot assisted or open retropubic prostatectomy
Primary Outcome Measure Information:
Title
Treatment failure.
Description
Treatment failure in HIFU focal ablation arm is classified as the need for secondary whole gland treatment as radical prostatectomy or EBRT. Treatment failure in radical prostatectomy arm is classified as PSA > 0.2 or positive surgical margins and need for EBRT.
Time Frame
At 36 months from the treatment date.
Secondary Outcome Measure Information:
Title
To compare urinary continence between focal ablation and radical prostatectomy.
Description
Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used. Variation in urinary continence according to the number of pads used/day due to continence problems compared to baseline. Categories are defined as (full continence= 0 pads/day; security pad or mild incontinence =1pad/day; moderate incontinence= 2pads/day and severe incontinence >2pads/day).
Time Frame
Within 36 months from the treatment date.
Title
To compare erectile function between focal ablation and radical prostatectomy.
Description
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.
Time Frame
Within 36 months from the treatment date.
Title
To compare quality of life between focal ablation and radical prostatectomy.
Description
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.
Time Frame
Within 36 months from the treatment date.
Title
Focal ablation failure.
Description
Focal ablation failure is classified as presence of clinically significant cancer on control MRI-3D TRUS image fusion guided biopsy in the treated prostate zone. At least 2 targeted biopsy cores will be localized in the treatment zone. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
Time Frame
Within 36 months from the treatment date.
Title
To compare short, medium and long term adverse events related to treatments.
Description
All adverse events will be registered prospectively.
Time Frame
Within 36 months from the treatment date
Title
Diagnostic failure.
Description
Diagnostic failure is classified as diagnosis of clinically significant cancer localized outside of treatment zone in treated lobe and in any region of non- treated prostate lobe. MRI and systematic radom prostate biopsy form each prostate sextant will be performed and location of each biopsy trajectory will be registered using Trinity (Koelis) device. Prostate biopsy will be performed at 12 and 36 months from the treatment date.
Time Frame
Within 36 months from the treatment date.
Title
Cancer progression including development of metastases.
Description
Whole body MRI or PET CT will be performed if suspicion on metastases.
Time Frame
Within 36 months years from the treatment date.
Title
Cancer specific and all-cause mortality.
Description
Cause of the mortality will be evaluated and registered.
Time Frame
Within 36 months from the treatment date.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Klara Sørbø, nurse
Phone
+47 23 03 31 88
Email
anklso@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Baco, MD, PhD
Organizational Affiliation
Department of Urology Aker, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology Aker, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduard Baco, MD, PhD
Phone
+47 22 89 40 00
Email
Eduard.Baco@medisin.uio.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data generated during this study will be evaluated at Oslo University Hospital

Learn more about this trial

Focal Prostate Ablation Versus Radical Prostatectomy

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