Status:
TERMINATED
Micro-ultrasound for Prostate Cancer Diagnosis
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a single-center, paired-cohort, prospective study. Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits. The results of the diagnostic procedures...
Eligibility Criteria
Inclusion
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Exclusion
- Prior treatment for prostate cancer
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
- Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
- Unfit to undergo any procedures listed in protocol
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04832997
Start Date
September 14 2020
End Date
July 16 2025
Last Update
July 20 2025
Active Locations (1)
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1
IRCCS San Raffaele
Milan, Italy, 20132