A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer

Inclusion Criteria

• •1. Confirmed prostate cancer by histopathology or cytology;
• •2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
• •3. Males at least 18 years of age;
• •4. Any of the following clinical criteria:
• •* High risk localized, treatment naive prostate cancer, defined as clinical ≥T3a, Gleason score ≥8 (or grade group 4-5), or PSA \>20ng/mL. Clinical T-stage may be defined based on physical exam or standard pelvic imaging (MRI/CT).
• •* High-tier intermediate risk, defined as at least two of the following: clinical T2c, Gleason score ≥7 (or Grade group 2-3) and PSA 10-20 ng/mL.
• •* Biochemically recurrent prostate cancer defined as persistently elevated or rising PSA after radical prostatectomy, with a PSA value of ≥0.2ng/mL on at least two readings, or PSA with a rise of at least ≥2 ng/mL above the nadir in patients who have received definitive radiation therapy (28).
• •* Metastatic disease documented on conventional imaging (CT and/or bone scan).
• •5. 99m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
• •6. Receipt of a complete \[18\]F-PSMA-1007 PET/CT or PET/MRI referral package, including baseline history information and treatment intent from the referring physician, prior to enrolment.
• •7. Able and willing to follow instructions and comply with the protocol;
• •8. Ability to provide written informed consent prior to participation in the study.