Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
To test whether giving dexamethasone with or without metronidazole in combination with abiraterone could help reverse resistance to abiraterone for patients with metastatic castration-resistant prostate cancer (mCRPC). Abiraterone and prednisone (AA/P) is a second-line therapy for mCRPC given when first-line androgen deprivation therapy fails. However, resistance to AA/P can develop. The investigators do not know exactly how cancer becomes resistant, but there is evidence that suggests it could be due to androgen production by the bacteria in your gut (gut microbiome). This study is focused on…
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 inf…
Abiraterone acetate 1000mg/ day
Dexamethasone 0.5mg/day
Metronidazole 1500mg/ per day
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