NCT06616597 Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
| NCT ID | NCT06616597 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2031-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 58 participants in total. It began in 2025-02-13 with a primary completion date of 2031-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
Eligibility Criteria
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.
Contact & Investigator
Catherine Handy Marshall, M.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06616597 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06616597 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06616597 currently recruiting?
Yes, NCT06616597 is actively recruiting participants. Contact the research team at dieg2@jhmi.edu for enrollment information.
Where is the NCT06616597 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06616597 clinical trial?
NCT06616597 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Catherine Handy Marshall, M.D. at Johns Hopkins University. The trial plans to enroll 58 participants.
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