Cisplatin in Castration Resistant Prostate Cancer

NCT03275857 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: UGUP-17050
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Cisplatin

OTHER

Drug: Cisplatin

Interventions

Cisplatin DRUG

Weekly IV

Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Roswell Park Cancer Institute: collaborator

Study Sites (1)

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: September 8, 2017
• Study Start: September 21, 2018
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)