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Cisplatin in Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03275857
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Deepak Sahasrabudhe, University of Rochester

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 21, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
Cisplatin Drug: Cisplatin
Weekly IV




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275857


Contacts
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Contact: Ayesha Khan 5852755531 ayesha_khan@urmc.rochester.edu

Locations
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United States, New York
Wilmot Cancer Institute Recruiting
Rochester, New York, United States, 14642
Contact: Ayesha Khan    585-275-3351    ayesha_khan@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
Roswell Park Cancer Institute
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Responsible Party: Deepak Sahasrabudhe, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03275857    
Other Study ID Numbers: UGUP-17050
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Cisplatin
Antineoplastic Agents