Health Trials

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

ConditionsProstate Cancer (Adenocarcinoma)Metastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Abiraterone acetate
  • Dexamethasone
  • Metronidazole

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

United States Department of Defense

Collaborator

Prostate Cancer Foundation

Collaborator

Source ClinicalTrials.gov