Clinical Trial

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-08-19; most recent amendment 2026-03-10.
Status change: Not Yet Recruiting → Recruiting 2026-03-10
Trial Details
NCT Number NCT07142551
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Bayer
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 60 participants
Start Date 2026-03-09
Primary Completion 2030-06-01 (estimated)
Study Completion 2034-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-11