Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2028-12-31
• 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; Michael Graham PhD, MD
• Treatments: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

Criteria

Inclusion Criteria:

• Ability to understand and willingness to provide informed consent.

• Pathologically proven prostate adenocarcinoma.

• Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).

• If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.

• If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').

• A PSA level result within the last 2 months meeting criteria above.

• 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 greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.

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.