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OpenTrials
Completed

NCT Number: NCT03275857

Cisplatin in Castration Resistant Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

Weekly IV

Primary outcomes

  1. Response to dosing differences of Cisplatin from lab and scan results

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Roswell Park Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2017
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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