Clinical Trials /

Cisplatin in Castration Resistant Prostate Cancer

NCT03275857

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Cisplatin in Castration Resistant Prostate Cancer
  • Official Title: A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide

Clinical Trial IDs

  • ORG STUDY ID: UGUP-17050
  • NCT ID: NCT03275857

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
CisplatinCisplatin

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CisplatinOther
  • Cisplatin

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response to dosing differences of Cisplatin from lab and scan results
Time Frame:2 years
Safety Issue:
Description:Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Rochester

Last Updated

October 2, 2019