BiPASS: This study is looking at better ways to diagnose prostate cancer using advanced imaging techniquesA Single Arm, Multicenter, Prospective, 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).

Inclusion

1. Male, at least 18 years old.
2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollment, but a clinician indicated intent to proceed with template biopsy due to non-imaging risk factors.

These are non-imaging risk factors that would lead a patient to be considered for a template biopsy (including but not exclusive to):

1. Persistently elevated or rising PSA i. PSA ≥ 3.0 ng/mL ii. Rising PSA velocity (e.g., >0.35-0.75 ng/mL/year over 2-3 years) is also considered suspicious, especially in men with PSA<10ng/mL.
2. High PSA density (PSAD) i. PSA density > 0.15 ng/mL/cm³ is considered high-risk for csPCa. ii. Calculated as PSA (ng/mL) divided by prostate volume (from MRI).

3. Abnormal digital rectal examination (DRE) i. abnormal findings include:

   1. Nodules
   2. Induration
   3. Asymmetry
   4. Fixation of the prostate ii. An abnormal DRE in any PSA range (including <3 ng/mL) increases cancer suspicion.

b) Strong family history of prostate cancer: i. First-degree relative (father or brother) with PCa ii. Any relative diagnosed at <65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g., BReast CAncer gene [BRCA]1/2, Homeobox protein Hox-B13 [HOXB13] mutations) c) Other high-risk biomarkers i. 4Kscore: ≥ 7.5-10% risk of high-grade PCa ii. PHI (Prostate Health Index): ≥ 35 suggests elevated risk iii. Prostate Cancer Antigen 3 (PCA3) Score: ≥ 35 considered positive and associated with increased risk of PCa.

iv. Any other established biomarker with values in the high-risk range d) Clinical presentation i. Symptoms suggestive of locally advanced disease (e.g., urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern 3. Prostate biopsy naïve participants. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines. 5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 6. Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result. 7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.

8. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG [Clinical Trial Facilitation Group], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.