68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Graham PhD, MD
• Collaborators: Holden Comprehensive Cancer Center; University of Iowa
• Treatments: Edetic Acid

Criteria

Inclusion Criteria:

• Pathologically proven prostate adenocarcinoma

• Rising PSA after definitive therapy with prostatecomy or radiation therapy (external beam or brachytherapy)

• If post-radical prostatecomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence)

• If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence)

• Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations)

• No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion)

• Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)

• Ability to understand and willingness to provide informed consent

Exclusion Criteria:

• Cannot receive furosemide

• History of Stevens Johnson syndrome

• History or diagnosis of Paget's disease

• Malignancy other than current disease under study

• Allergy to sulfa or sulfa-containing medications

• 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