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Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

StatusRecruiting
PhasePhase 2
Started2026-03-09
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-03-20→confirmed 2026-03-09
Study sitesdetails revised at 1 of 1 site
2026-02-25
Study Status v5
Start date2026-02-20→2026-03-20
2025-12-10
Study Status v4
Start date2025-12-30→2026-02-20
2025-11-06
Study Status v3
Start date2025-10-30→2025-12-30
2025-09-22
Study Status v2
Primary completion date2030-05-01→2030-06-01
Completion date2034-05-01→2034-06-01
Start date2025-09-30→2025-10-30
2025-08-26
Study Status v1
Re-verified, no change to tracked fields
2025-08-19
Original filing
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.
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