drugset / Trial / NCT07069465
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
Phase 0
Completed
10 enrolled
Urology Clinics of North Texas
Blue Earth Diagnostics · collabTexas Health Resources · collab
Non-randomizedParallel-groupOpen-labelDiagnostic
Summary
This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.
Timeline
- Start
- 2024-06-15
- Primary completion
- 2024-11-06
- Completion
- 2024-11-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Relugolix | Small molecule | 120 mg | Oral |