Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study
Phase 1
40 Years
85 Years
40 Years
85 Years
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study
Inclusion Criteria:
- Patient of age between 40 to 85
- Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy
(min:12 cores)
- Patient with PSA ≤ 10 ng/mL
- Gleason score 6 (3+3) or max 7 (3+4)
- Up to two (2) MR identifiable lesions
- No definite evidence of extracapsular extension
Exclusion Criteria:
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS
treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Any rectal pathology, anomaly or previous treatment
- Identified calcification of 2 mm or more in largest diameter neighboring the rectal
wall
- Bladder cancer
- Seminal vesicle/lymph node
- Prostate with multiple cystic lesions
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Safety
Outcome Description:
Measure of expected or UN-expected adverse events
Outcome Time Frame:
One year
Safety Issue:
Yes
Principal Investigator
alessandro napoli, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Radiological Sciences, Sapienza University of Rome
Authority:
Italy: Ethics Committee
Study ID:
PCa-MRgFUS-I
NCT ID:
NCT01522118
Start Date:
January 2011
Completion Date:
June 2012
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- High Intensity Focused Ultrasound
- Magnetic Resonance guided Focused Ultrasound
- Non-invasive therapy
- Focal Disease
- Prostatic Neoplasms
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