Description:
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.
Recruiting
Early Phase 1
Drug | Synonyms | Arms |
---|---|---|
Cisplatin | Cisplatin |
Name | Type | Description | Interventions |
---|---|---|---|
Cisplatin | Other |
|
Inclusion Criteria: - Histologic diagnosis of prostate cancer - Age 18 yrs or older - Able to provide written, informed consent - Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate - Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression Exclusion Criteria: - Subjects with estimated glomerular filtration rate of less than 50 ml/min - Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment. - Subjects with grade 2 or greater neuropathy - Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin - Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Response to dosing differences of Cisplatin from lab and scan results |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases. |
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Rochester |
March 3, 2021