Status:
UNKNOWN
PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
This is prospective single-arm case-control study designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate bio...
Detailed Description
All patients fulfilling inclusion criteria and providing informed consent to the study will undergo mpMRI and PSMA PET followed by software assisted fusion biopsy, performed in day-hospital setting. ...
Eligibility Criteria
Inclusion
- Age \>18 years
- blood PSA level \>4.0ng/ml;
- free-to-total PSA ratio \<20%;
- progressive rise of PSA levels in two consecutive blood samples despite antibiotics;
- serum blood tests suspicious for PCa;
- at least one previous negative biopsy (min 12 cores);
- ASAP and/or high-grade PIN;
- negative digital rectal examination.
Exclusion
- antiandrogen therapy;
- prostate needle biopsy \<21 days before PET and/or mpMRI;
- known active secondary cancer;
- endorectal coil/probe not applicable;
- active prostatitis;
- anaphylaxis against gadolinium-DOTA.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05297162
Start Date
April 1 2022
End Date
January 1 2025
Last Update
April 28 2022
Active Locations (1)
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1
IRCCS Humanitas Research Hospital
Rozzano, Italy, 20089