Status:
COMPLETED
MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
PHASE1
Brief Summary
Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01522118
Start Date
January 1 2011
End Date
June 1 2012
Last Update
February 26 2013
Active Locations (1)
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1
Department of Radiological Sciences, Sapienza University of Rome
Rome, Italy, 00100