Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

1. Histopathological proven prostate adenocarcinoma.

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

1. Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.

3. Karnofsky performance status of ≥ 50.

4. Age ≥ 18.

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

Exclusion Criteria:

1. Current investigational therapy for prostate cancer.

2. Unable to lie flat, still or tolerate a PET/CT scan.

3. Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.

4. Prisoner.