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OncoMatch/Clinical Trials/NCT06616597

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

Is NCT06616597 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abiraterone acetate and Dexamethasone for prostate cancer (adenocarcinoma).

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT06616597Data as of May 2026

Treatment: Abiraterone acetate · Dexamethasone · MetronidazoleTo determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Prior therapy

Must have received: abiraterone (abiraterone, prednisone)

PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.

Must have received: LHRH agonist or orchiectomy

Must be maintained on a GnRH analogue or have undergone orchiectomy.

Cannot have received: investigational therapeutic or invasive surgical procedure (not including surgical castration)

Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study

Cannot have received: antibacterial therapy

On antibacterial therapy within 30 days prior to administration of study treatment.

Lab requirements

Liver function

Chronic liver disease with Child-Pugh class C cirrhosis; Bilirubin >3x ULN or AST and ALT >5x ULN

Cardiac function

Congenital prolonged QTc syndrome or QTc > 500 msec (non-paced rhythm)

Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol); Bilirubin >3x ULN or AST and ALT >5x ULN; Congenital prolonged QTc syndrome or QTc > 500 msec (non-paced rhythm)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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