<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03275857</url>
  </required_header>
  <id_info>
    <org_study_id>UGUP-17050</org_study_id>
    <nct_id>NCT03275857</nct_id>
  </id_info>
  <brief_title>Cisplatin in Castration Resistant Prostate Cancer</brief_title>
  <official_title>A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to&#xD;
      enzalutimide in patients with CRPC by affecting AR function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response to dosing differences of Cisplatin from lab and scan results</measure>
    <time_frame>2 years</time_frame>
    <description>Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toxicity observed with dosing differences of Cisplatin</measure>
    <time_frame>2 years</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Cisplatin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Weekly IV</description>
    <arm_group_label>Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of prostate cancer&#xD;
&#xD;
          -  Age 18 yrs or older&#xD;
&#xD;
          -  Able to provide written, informed consent&#xD;
&#xD;
          -  Subjects who have received docetaxel for metastatic disease are eligible if absolute&#xD;
             neutrophil count is greater than 100 and platelet count is greater than 100,000 and&#xD;
             their bone marrow reserve is deemed to be adequate&#xD;
&#xD;
          -  Subjects with castration resistant prostate cancer, as defined by having testosterone&#xD;
             level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in&#xD;
             PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic&#xD;
             radiographic progression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with estimated glomerular filtration rate of less than 50 ml/min&#xD;
&#xD;
          -  Subjects with hearing impairment. The treating physician may decide which subjects&#xD;
             should not receive cisplatin based on audiometry or based on clinical judgment.&#xD;
&#xD;
          -  Subjects with grade 2 or greater neuropathy&#xD;
&#xD;
          -  Subjects who in the opinion of the treating physician could not tolerate the standard&#xD;
             hydration before receiving cisplatin&#xD;
&#xD;
          -  Chemotherapy naïve subjects who in the opinion of the treating physician should&#xD;
             receive docetaxel instead of enrolling on the trial and receive cisplatin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ayesha Khan</last_name>
    <phone>5852755531</phone>
    <email>ayesha_khan@urmc.rochester.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wilmot Cancer Institute</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayesha Khan</last_name>
      <phone>585-275-3351</phone>
      <email>ayesha_khan@urmc.rochester.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Deepak Sahasrabudhe</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03275857
org study id: UGUP-17050
nct id: NCT03275857
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to
      enzalutimide in patients with CRPC by affecting AR function.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response to dosing differences of Cisplatin from lab and scan results
time frame: 2 years
description: Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.
measure: Toxicity observed with dosing differences of Cisplatin
time frame: 2 years
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.
arm group label: Cisplatin
arm group type: Other
intervention type: Drug
intervention name: Cisplatin
description: Weekly IV
arm group label: Cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ayesha Khan
phone: 5852755531
email: ayesha_khan@urmc.rochester.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Deepak Sahasrabudhe
investigator title: Professor
mesh term: Prostatic Neoplasms
mesh term: Cisplatin