68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma

• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

  • Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

    • PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
    • Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)

  • Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

    • A rise of PSA measurement of 2 or more ng/mL over the nadir

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

• Able to provide written consent

Exclusion Criteria:

• Investigational therapy for prostate cancer.
• Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.