Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2017-09-30
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Focal prostate cancer treatment by HIFU
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.
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
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.
Radical prostatectomy
Prostatectomy arm:
Robot assisted or open retropubic prostatectomy
Interventions
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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
Radical prostatectomy
Prostatectomy arm:
Robot assisted or open retropubic prostatectomy
Eligibility Criteria
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Inclusion Criteria
* PSA ≤ 20 ng/ml
* Treatment naive patients with localized prostate cancer (stage ≤ T2b)
Exclusion Criteria
* 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
45 Years
80 Years
MALE
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Eduard Baco
Principal Investigator
Principal Investigators
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Eduard Baco, MD, PhD, Prof. assoc.
Role: PRINCIPAL_INVESTIGATOR
Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet
Locations
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Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet
Oslo, , Norway
Countries
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Other Identifiers
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2017/703
Identifier Type: -
Identifier Source: org_study_id
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