RecruitingPhase 2NCT06616597

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

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

58 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether targeting a specific type of gut bacteria that produce androgens (male hormones) can help reverse resistance to abiraterone — a hormone therapy commonly used for prostate cancer. Some prostate cancers stop responding to abiraterone because gut bacteria continue producing the hormones that fuel cancer growth; this study tests whether an antibiotic (metronidazole) can disrupt that process. **You may be eligible if...** - You are a male 18 years or older - You have been diagnosed with prostate cancer (adenocarcinoma) - Your PSA level is 2.0 ng/mL or higher - Your cancer has progressed while on abiraterone and prednisone for at least 12 weeks - You are on hormone-suppressing therapy (GnRH analogue) or have had surgical removal of the testes - Your life expectancy is at least 6 months - You are willing to collect urine and stool samples and abstain from alcohol during the study **You may NOT be eligible if...** - You have an active infection that makes steroid use dangerous - You require high doses of corticosteroids for another condition - You have significant liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone acetate

Abiraterone acetate 1000mg/ day

DRUGDexamethasone

Dexamethasone 0.5mg/day

DRUGMetronidazole

Metronidazole 1500mg/ per day


Locations(1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

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NCT06616597


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