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

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).

NCT Number	NCT07593079
Lead Sponsor	Washington University School of Medicine Collaborators: The Society of Nuclear Medicine and Molecular Imaging
Conditions	Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic
Enrollment	20 participants
Start Date	2026-07-31
Primary Completion	2027-08-14 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-01