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Recruiting
NCT07052214
PSMA PET Combined With MRI for the Detection of PCa
Conditions: PCA, Prostate Cancer, Prostatic Neoplasm, PSMA PET, Diagnostic Imaging, Elevated PSA, Positron Emission Tomography, Prostate Biopsy, Carcinoma of the Prostate
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 338
Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Location: University of California Los Angeles Los Angeles California
Summary
This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).
Eligibility Criteria
Inclusion Criteria:
1. Male, at least 18 years old.
2. Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and/or have non-imaging risk factors (including but not exclusive to):
a) Persistently elevated or rising PSA b) High PSA density c) Abnormal digital rectal examination (DRE) d) Strong family history of prostate cancer: i. First-degree relative (father or brother) with csPCa ii. Any relative diagnosed at \
Source: ClinicalTrials.gov (NCT07052214). StuddyBuddy aggregates publicly available trial information.
