Clinical Trial

PSMA PET Combined With MRI for the Detection of PCa

Study acronym: BiPASS
Recruiting Phase 3
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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).
Protocol Amendment History 4 changes
notable Enrollment increased: 204 -> 338 participants 2026-07-24
notable Trial sites expanded: 1 -> 18 locations 2026-07-24
notable Primary completion pushed: 2026-06 -> 2027-01 2026-07-24
minor Completion pushed: 2026-11 -> 2027-04 2026-07-24
Trial Details
NCT Number NCT07052214
Lead Sponsor Telix Pharmaceuticals (Innovations) Pty Limited
Collaborators: Telix Innovations S.A.
Conditions PCA, Prostate Cancer, Prostatic Neoplasm, PSMA PET, Diagnostic Imaging, Elevated PSA, Positron Emission Tomography, Prostate Biopsy +1 more
Enrollment 338 participants
Start Date 2025-08-18
Primary Completion 2027-01 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-23