Status:
COMPLETED
Cisplatin in Castration Resistant Prostate Cancer
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03275857
Start Date
September 21 2018
End Date
July 31 2023
Last Update
June 10 2024
Active Locations (1)
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1
Wilmot Cancer Institute
Rochester, New York, United States, 14642