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Focal Prostate Ablation Versus Radical Prostatectomy (FARP)

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ClinicalTrials.gov Identifier: NCT03668652
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Eduard Baco, Oslo University Hospital

Brief Summary:
This study aims to compare the treatment results of HIFU and Radical prosatectomy

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Focal HIFU treatment using Focal One (EDAP TMS) Procedure: Radical prostatectomy Not Applicable

Detailed Description:
The FARP randomized control study will compare focal ablation of prostate using High Intensity Focused Ultrasound (HIFU) applied by Focal One HIFU device versus Radical Prostatectomy (RP) in patients with unilateral, intermediate risk prostate cancer

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Masking Description: Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Focal prostate cancer treatment by HIFU
Focal HIFU treatment using Focal One (EDAP TMS) device will be applied to the prostate region where MRI and 3D-TRUS registered prostate biopsy detected clinically significant prostate cancer. Treatment efficacy will be per-operatively controlled using dynamic contrast enhanced ultrasound. If like non-necrotic area within the treatment zone will be identified, additional HIFU treatment limited to sub-optimally treated regions will be performed during the same intervention.
Device: Focal HIFU treatment using Focal One (EDAP TMS)

HIFU arm:

Focal ablation of prostate cancer using HIFU Focal One


Active Comparator: Radical Prostatectomy
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.
Procedure: Radical prostatectomy

Prostatectomy arm:

Robot assisted or open retropubic prostatectomy





Primary Outcome Measures :
  1. Treatment failure. [ Time Frame: At 36 months from the treatment date. ]

    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 and need for EBRT.



Secondary Outcome Measures :
  1. To compare urinary continence between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]
    EPIC-26 questionnaire for the evaluation of continence will be used.

  2. To compare erectile function between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]
    IIEF-5 questionnaire for the evaluation erectil function will be used.

  3. To compare quality of life between focal ablation and radical prostatectomy. [ Time Frame: Within 36 months from the treatment date. ]
    EORTC QLQ-C30 questionnaire for the evaluation of quality of life between focal ablation and radical prostatectomy will be used.

  4. Focal ablation failure. [ Time Frame: Within 36 months from the treatment date. ]

    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.


  5. To compare short, medium and long term adverse events related to treatments. [ Time Frame: Within 36 months from the treatment date ]
    All adverse events will be registered prospectively.

  6. Diagnostic failure. [ Time Frame: Within 36 months from the treatment date. ]
    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.

  7. Cancer progression including development of metastases. [ Time Frame: Within 36 months years from the treatment date. ]
    Whole body MRI or PET CT will be performed if suspicion on metastases.

  8. Cancer specific and all-cause mortality. [ Time Frame: Within 36 months from the treatment date. ]
    Cause of the mortality will be evaluated and registered.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males
Accepts Healthy Volunteers:   No
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
  • Haemorrhagic risk patients
  • Urogenital infection in progress
  • Allergy to latex or gadolinium
  • Patients on life support or suffering form unstable neurological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668652


Contacts
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Contact: Anne Klara Sørbø, nurse +47 23 03 31 88 anklso@ous-hf.no

Locations
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Norway
Department of Urology Aker, Oslo University Hospital Recruiting
Oslo, Norway, 0514
Contact: Eduard Baco, MD, PhD    +47 22 89 40 00    Eduard.Baco@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Principal Investigator: Eduard Baco, MD, PhD Department of Urology Aker, Oslo University Hospital

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Responsible Party: Eduard Baco, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03668652     History of Changes
Other Study ID Numbers: 2017/703
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data generated during this study will be evaluated at Oslo University Hospital

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduard Baco, Oslo University Hospital:
Prostate Cancer
HIFU Focal Treatment
Radical prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases