drugset / Trial / NCT07593079
Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer
Phase 2
Not yet recruiting
20 enrolled
Washington University School of Medicine
The Society of Nuclear Medicine and Molecular Imaging · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 18F-rhPSMA-7.3 | Diagnostic / imaging agent | — | Intravenous |
| Background | Bicalutamide | Other / unclassified | — | Oral |