drugset / Trial / NCT07593079

Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer

NCT07593079

RandomizedParallel-groupOpen-labelDiagnostic

Summary

This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).

Timeline

Start
2026-07-31
Primary completion
2027-08-14
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-rhPSMA-7.3 Diagnostic / imaging agent Intravenous
Background Bicalutamide Other / unclassified Oral