68Ga PSMA in Preprostatectomy Patients

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• 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
• Collaborators: Holden Comprehensive Cancer Center; University of Iowa
• Treatments: Edetic Acid

Criteria

Inclusion Criteria:

• Biopsy-proven prostate adenocarcinoma

• Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater

• A PSA level resulted within the past 2 months

• Planned prostatectomy with lymph node dissection

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

• Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)

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

• Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

• Cannot receive furosemide

• Allergy to sulfa or sulfa-containing medications

• History of Stevens-Johnson syndrome

• Known Paget's disease

• 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