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 the gut microbiome as a source of androgen production that could cause AA/P resistance in mCRPC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Abiraterone acetate 1000mg/ day
Dexamethasone 0.5mg/day
Metronidazole 1500mg/ per day
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGNumber of participants with PSA30 response
Number of participants with castration resistant prostate cancer who have a ≥ 30% decline in PSA from baseline until 24 weeks.
Time frame: 24 weeks
Number of participants with PSA50 response
Number of participants with castration resistant prostate cancer who have a ≥ 50% decline in PSA from baseline until 12 weeks.
Time frame: 12 weeks
PSA Progression Free Survival
Number of participants with PSA progression according to PCWG3 (25% rise in PSA from nadir and increase of at least 2ng/mL)
Time frame: 12 weeks
Number of participants with progression
progression is defined as: * Progression of soft tissue lesions according to RECIST 1.1 Criteria. * Progression of bone lesions detected with bone scan according to PCWG3 criteria. * Radiologically-confirmed spinal cord compression or pathological fracture due to malignant progression, or other clinical event deemed to be cancer-related, or death.
Time frame: 24 weeks
Number of grade 3-5 toxicities
Toxicity is evaluated based on current CTCAE standard grading scales.
Time frame: 24 weeks
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