Cisplatin in Castration Resistant Prostate Cancer

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Cisplatin

• Registration Number: NCT03275857
• Lead Sponsor: University of Rochester

Brief Summary

It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-08
• Study Start: 2018-09-21
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wilmot Cancer Institute; 🇺🇸 Rochester, New York, United States