drugset / Trial / NCT04787744
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2026-09-30
- Completion
- 2029-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Abiraterone acetate | Small molecule | — | — |
| Background | Apalutamide | Small molecule | — | — |
| Background | Bicalutamide | Other / unclassified | — | — |
| Background | Degarelix | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Enzalutamide | Other / unclassified | — | — |
| Background | Flutamide | Small molecule | — | — |
| Background | Goserelin | Other / unclassified | — | — |
| Background | Histrelin | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Nilutamide | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Relugolix | Small molecule | — | — |
| Background | Triptorelin | Other / unclassified | — | — |