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Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

StatusRecruiting
PhasePhase 2
Started2025-02-13
View on ClinicalTrials.gov ↗

Amendment history

2026-02-17
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2025-02-28
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations, IPDSharing v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-30→confirmed 2025-02-13
Study sites2→1
Study description+697 characters
To test whether giving dexamethasone with or without metronidazole in combination with abiraterone could help reverse resistance to abiraterone for patients with metastatic castration-resistant prostate cancer (mCRPC). Abiraterone and prednisone (AA/P) is a second-line therapy for mCRPC given when f [...]
Collaborators+62 characters
United States Department of Defense Prostate Cancer Foundation
Study title-9 characters
Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse [...]
2024-12-10
Study Status v1
Primary completion date2030-12-30→2031-03-30
Completion date2030-12-30→2032-03-30
Start date2024-12-30→2025-03-30
2024-09-26
Original filing
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
Trial Details
NCT Number NCT06616597
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: United States Department of Defense, Prostate Cancer Foundation
Conditions Prostate Cancer (Adenocarcinoma), Metastatic Prostate Cancer
Enrollment 58 participants
Start Date 2025-02-13
Primary Completion 2031-03-30 (estimated)
Study Completion 2032-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-19