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Cisplatin in Castration Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilmot Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2017
Last Updated
July 12, 2023
Sponsor
University of Rochester
Collaborators
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03275857
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Weekly IV
Primary Outcome Measure Information:
Title
Response to dosing differences of Cisplatin from lab and scan results
Description
Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.
Time Frame
2 years
Title
Toxicity observed with dosing differences of Cisplatin
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Khan
Phone
5852755531
Email
ayesha_khan@urmc.rochester.edu
Facility Information:
Facility Name
Wilmot Cancer Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Khan
Phone
585-275-3351
Email
ayesha_khan@urmc.rochester.edu

12. IPD Sharing Statement

Learn more about this trial

Cisplatin in Castration Resistant Prostate Cancer

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