An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer

Inclusion Criteria:

• Pathologically proven prostate adenocarcinoma

• For the initial staging arm (initial staging cohort), high risk characteristics,including any of the following:

• Grade group 4-5 and/or

• PSA > 20 ng/mL

• For patients with biochemical recurrence (biochemical recurrence cohort):

• Rising PSA after definitive therapy with prostatectomy or targeted localtherapy (including but not limited to external beam radiation therapy,brachytherapy, high-frequency ultrasound, and cryotherapy)

• If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weekspost-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence

• If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mLrise above PSA nadir (American Society of Radiation Oncology (ASTRO) definitionfor biochemical recurrence)

• For patients undergoing systemic therapy (treatment monitoring cohort):

• Diagnosis of metastatic castration-resistant prostate cancer

• At least one or more measurable ( > 1 cm diameter in short axis) or evaluablelesions by any modality obtained within the past 60 days

• Planned for treatment with standard of care androgen receptor pathway inhibitoror chemotherapy

• This can include patients who have already undergone a standard of care Ga-68 PSMAPET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom thePET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and whoare planned to start treatment on chemotherapy or androgen receptor signalinginhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also includepatients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for risingPSA to help with restaging prior to starting new treatment with ARSI orchemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 mustbe completed within 30 days of enrollment. Any patient with an equivocal lesion byconventional imaging, regardless of where they are in the course of evaluation ortreatment (equivocal lesion cohort)

• No other malignancy within the past 2 years (with the exception of skin basal cellor cutaneous superficial squamous cell carcinoma, superficial bladder cancer,carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia,which are allowed)

• Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performancestatus grades 0, 1, or 2

• Ability to understand and willingness to provide informed consent

Exclusion Criteria:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements