Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68-labeled PSMA-11 PET whole body imaging for detection of disease
recurrence in clinically relevant anatomic regions.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes
after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

After completion of study, patients are followed up for 3-12 months.

Inclusion Criteria:

- Histopathological proven prostate adenocarcinoma

- Rising PSA after definitive therapy with prostatectomy or radiation therapy.

- Post radical prostatectomy (RP)

- PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP

- Post-radiation therapy ? American Society for Therapeutic Radiation and Oncology
(ASTRO)-Phoenix consensus definition

- Nadir + greater than or equal to 2 ng/mL rise in PSA

- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/
World Health Organization [WHO] equivalent)

- Ability to understand a written informed consent document, and the willingness to sign
it

Exclusion Criteria:

- Concomitant investigational therapy

- Unable to lie flat, still or tolerate a PET scan

- Patient undergoing active treatment for non-prostate malignancy, other than skin basal
cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
superficial bladder cancer