Clinical Trial · NCT03822845

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

Overview

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.

Sponsor

University of Iowa

Phase

Phase 2/3

Contacts

Michael M Graham, Ph.D., MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT03822845

Drug / Compound

PSMA-HBED-CC

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

A PSA level result within the last 2 months meeting criteria above.
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.
Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
Pathologically proven prostate adenocarcinoma.
Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.
Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).
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').

Exclusion

Cannot receive furosemide.
Malignancy other than current disease under study.
History or diagnosis of 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.
History of Stevens-Johnson syndrome.
Allergy to sulfa or sulfa-containing medications.