Prostate Cancer
Conditions
Brief summary
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.
Interventions
DRUGCisplatin
Weekly IV
Sponsors
Roswell Park Cancer Institute
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to dosing differences of Cisplatin from lab and scan results | 2 years | Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases. |
| Toxicity observed with dosing differences of Cisplatin | 2 years | Blood samples and physical assessments will be conducted and reviewed to determine toxicity of treatment. Toxicity would be symptoms such as ringing in the ears (tinnitus) peripheral neuropathy or lab findings such as rise in creatinine, electrolyte abnormalities such as low magnesium. |
Countries
United States
Outcome results
None listed