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 local therapy (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 weeks post-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/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for 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 evaluable lesions by any modality obtained within the past 60 days
Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
No other malignancy within the past 2 years (with the exception of skin basal cell or 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) performance status 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 active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements