Gallium Ga 68-labeled PSMA-11 PET / CT in Diagnosing Participants with Biochemical Recurrent Prostate Cancer

This phase II trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET) / computed tomography (CT) works in diagnosing patients with prostate cancer and with rising prostate specific antigen after treatment. Ga-68 PSMA is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT, may help find the presence of prostate cancer.

Inclusion Criteria

• Histopathological proven prostate adenocarcinoma
• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation ** PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and, ** Confirmatory persistent PSA greater than 0.2 ng/mL * Post-radiation therapy –American Society for Therapeutic Radiology and Oncology (ASTRO) (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

• Current investigational therapy for prostate cancer
• Unable to lie flat, still or tolerate a 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
• Prisoner

PRIMARY OBJECTIVES:

I. Determine the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga PSMA-11) PET/CT for detecting prostate cancer on a per-patient basis, confirmed by histopathology.

SECONDARY OBJECTIVES:

I. Determine sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 PET/CT for detection of tumor location confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available.

II. Determine detection rates on a per-subject basis of 68Ga PSMA-11 PET/CT stratified by prostate-specific antigen (PSA) value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - < 5.0, 5.0 or greater).

III. Determine the impact of 68Ga PSMA-11 PET/CT on clinical management in patients who have prostate cancer with biochemical recurrence.

IV. Continue to evaluate safety of 68Ga-PSMA-11.

OUTLINE:

Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Within 50-100 minutes, participants undergo PET/CT over 30-40 minutes.

After completion of study treatment, participants are followed up for 1 day and then up to 12 months.

Trial Phase Phase II

Trial Type Diagnostic

Lead Organization
University of Michigan Comprehensive Cancer Center

Principal Investigator
Morand Piert

• Primary ID UMCC 2017.016
• Secondary IDs NCI-2018-00297
• Clinicaltrials.gov ID NCT03396874