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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 (Jun 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 Jun 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

Treatments studied

Endocrine / hormonal

Abiraterone acetate

Other

DexamethasoneMetronidazole

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Demographics

Male only

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 →

Frequently asked questions

Is NCT06616597 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior investigational therapeutic or invasive surgical procedure (not including surgical castration), antibacterial therapy disqualifies patients from enrollment.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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