Recruiting
Phase 2

Dexamethasone & Metronidazole

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06616597

Conditions

Prostate Cancer (Adenocarcinoma)

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abiraterone acetate

Dexamethasone

Metronidazole

Study Details

Brief summary:

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

Conditions

Prostate Cancer (Adenocarcinoma)

Metastatic Prostate Cancer

Study ID

NCT06616597

Start date

Feb 13, 2025

Status verified date

Feb, 2026

Completion date

Mar 30, 2032

Anticipated

Primary completion date

Mar 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males aged 18 years of age and above.
  • Prostate adenocarcinoma
  • Absolute PSA ≥ 2.0 ng/mL at screening.
  • PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.
  • Must be maintained on a GnRH analogue or have undergone orchiectomy.
  • Participants must have a life expectancy ≥ 6 months
  • Ability to swallow study medication tablets
  • Willing to abstain from alcohol during and for 14 days after treatment with metronidazole
  • Willing and able to collect urine and stool samples per protocol

Exclusion Criteria:

  • Active infection or other medical condition that would make dexamethasone use contraindicated
  • Any chronic medical condition requiring a higher systemic dose of corticosteroid
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Has imminent or established spinal cord compression based on clinical findings and/or MRI.
  • 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)
  • History of pituitary or adrenal dysfunction
  • Uncontrolled diabetes (Hemoglobin A1c \> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.
  • 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
  • Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:

  • Any uncontrolled major infection.
  • Crohn's disease or ulcerative colitis.
  • Known or suspected toxic megacolon and/or known small bowel ileus.
  • Known allergy to any of the compounds under investigation.
  • On antibacterial therapy within 30 days prior to administration of study treatment.
  • Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study.

Study Design

Enrollment

58 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Abiraterone + Dexamethasone

Abiraterone acetate plus dexamethasone

experimental: Arm 2: Abiraterone + Dexamethasone + metronidazole

Abiraterone acetate plus dexamethasone plus metronidazole

Interventions

Abiraterone acetate

Abiraterone acetate 1000mg/ day

Dexamethasone

Dexamethasone 0.5mg/day

Metronidazole

Metronidazole 1500mg/ per day

Primary outcome measure

  • Number of participants with PSA30 response [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Donna Bieg, RN

410-502-7635dieg2@jhmi.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Irina Rifkind, RN

410-502-2043Irifkin1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Abiraterone
  • microbiome
  • Dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-02-19.