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

Metastatic Prostate Cancer Prostate Cancer (Adenocarcinoma)

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

Inclusion Criteria9

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 Criteria17

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.