Cisplatin in Castration Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03275857
• Other study ID #: UGUP-17050
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 21, 2018
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Ayesha Khan
• Phone: 5852755531
• Email: ayesha_khan[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Cisplatin
Weekly IV

Locations

Country	Name	City	State
United States	Wilmot Cancer Institute	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to dosing differences of Cisplatin from lab and scan results	Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.	2 years
Primary	Toxicity observed with dosing differences of Cisplatin	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.	2 years