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

NCT06616597 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-19

No results posted yet for this study

Summary

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

Conditions

Interventions

DRUG

Abiraterone acetate

Abiraterone acetate 1000mg/ day

DRUG

Dexamethasone

Dexamethasone 0.5mg/day

DRUG

Metronidazole

Metronidazole 1500mg/ per day

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Prostate Cancer Foundation

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Catherine Handy Marshall, M.D. · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2031-03-30
Completion
2032-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616597 on ClinicalTrials.gov