drugset / Trial / NCT07142551
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Phase 2
Recruiting
60 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bayer · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Timeline
- Start
- 2026-03-09
- Primary completion
- 2030-06-01
- Completion
- 2034-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | — |
| Subject | Testosterone Cypionate | Small molecule | 400 mg | Intramuscular |
| Background | Decapeptyl | Unknown | — | — |
| Background | Degarelix | Other / unclassified | — | — |
| Background | Goserelin | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |
| Background | Relugolix | Small molecule | — | — |