PSMA PET Combined With MRI for the Detection of PCa

This is a single arm, multicenter, prospective, open label Phase 3 study with PSMA PET for the detection of PCa. A total of 338 participants will be enrolled from approximately 25 investigative sites in the United States and Australia. Participants with a clinical suspicion of PCa, who will undergo template biopsy, based on initial MRI (PI-RADs 3-4) within 6 months before enrollment and/or based on clinical suspicion (for PI-RADs 1-2) and who have never undergone a prostate biopsy will be eligible for the study. All participants will first undergo MRI and PSMA PET scans, followed by standard 12 core anatomical (2 core six sectors) template biopsy. If the patient does not have a biopsy, at the discretion of clinician, they'll be followed up at 6month visit. If additional lesions are detected on MRI and/or PSMA PET, MRI and/or PMSA PET targeted biopsy can be performed (according to clinician judgment). Both MRI and/or PSMA targeted biopsies will be performed with 2 cores per lesion or as per institutional standards. Clinicians may use PSMA PET to rule out the need for biopsy, in which case, the patient will not have a histopathological SOT and will need to be followed up at 6 months. All biopsy and clinical care decisions are at the discretion of the investigator/clinician (i.e. the clinician may decide to: not biopsy, solely template biopsy, additional targeted biopsies, etc.) Participants presenting with csPCa will undergo therapy/management as per institutional standard, or according to clinician judgment. Follow-up data will be collected for up to 6-months for participants (participants with no baseline imaging or histopathological evidence of PCa). Additional imaging, template and/or targeted biopsies may be performed during the follow-up period, at the discretion of the investigator. Any additional biopsy, imaging, clinical, histological, genetic, and intervention data will contribute to the determination of the CSOT. Follow-up will provide longitudinal surveillance to ensure that participants initially evaluated as negative for PCa on both imaging and histopathology are reliably negative.