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 twoweeks 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 bedefined based on physical exam or standard pelvic imaging (MRI/CT).

• High-tier intermediate risk, defined as at least two of the following: clinicalT2c, Gleason score ≥7 (or Grade group 2-3) and PSA 10-20 ng/mL.

• Biochemically recurrent prostate cancer defined as persistently elevated orrising PSA after radical prostatectomy, with a PSA value of ≥0.2ng/mL on atleast two readings, or PSA with a rise of at least ≥2 ng/mL above the nadir inpatients 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 ofstudy enrollment.

6. Receipt of a complete [18]F-PSMA-1007 PET/CT or PET/MRI referral package, includingbaseline 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.

Exclusion Criteria:

1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,etc.);

2. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);

3. Weight exceeding the PET/CT or PET/MRI scanner limit;

4. Known allergic reaction to [18]F-PSMA-1007;

5. Patients who have initiated new therapy (ADT, systemic therapy, or radiation) fortheir prostate cancer within 4 weeks of enrollment in those with high-tierintermediate risk or high risk localized prostate cancer, or biochemically recurrentprostate cancer post-prostatectomy or definitive radiotherapy.