Cisplatin in Castration Resistant Prostate Cancer

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03275857
• Collaborator: Roswell Park Cancer Institute (Other)
• Enrollment: 37
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 55.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Cisplatin	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide
• Actual Study Start Date: Sep 21, 2018
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Cisplatin	Drug: Cisplatin; Weekly IV

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilmot Cancer Institute	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• Roswell Park Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deepak Sahasrabudhe, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03275857
• Other Study ID Numbers: UGUP-17050
• First Posted: Sep 8, 2017
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Cisplatin

Study Results

No Results Posted as of Jun 9, 2022