<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/NCT01697384</url>
  </required_header>
  <id_info>
    <org_study_id>301</org_study_id>
    <nct_id>NCT01697384</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer</brief_title>
  <official_title>Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endo Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant&#xD;
      (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer&#xD;
      during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified&#xD;
      to eliminate the Lupron arm and continued the study as an open-label non-randomized study.&#xD;
&#xD;
      Primary endpoint was testosterone suppression, as assessed by the percent of patients whose&#xD;
      testosterone indicated chemical castration levels (&lt;=50 ng/dL) through 52 weeks of treatment&#xD;
      with an implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments,&#xD;
      eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety&#xD;
      was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical&#xD;
      examinations, and ECGs. Local tolerability outcomes were also evaluated.&#xD;
&#xD;
      An extension period for the study included annual replacement of the implant until the&#xD;
      implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during&#xD;
      the extension period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2000</start_date>
  <completion_date type="Actual">October 2004</completion_date>
  <primary_completion_date type="Actual">August 2003</primary_completion_date>
  <phase>Phase 3</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>Suppression of testosterone to chemical castration levels (&lt;= 50 ng/dL)</measure>
    <time_frame>52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA measurements</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measurements</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL outcomes</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Adenocarcinoma of the Prostate</condition>
  <arm_group>
    <arm_group_label>one histrelin acetate 50 mg implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>histrelin acetate</intervention_name>
    <description>52 week implant</description>
    <arm_group_label>one histrelin acetate 50 mg implant</arm_group_label>
    <other_name>Vantas</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male Age 45 or older&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Disease Staging III or IV&#xD;
&#xD;
          -  Clinical indication for androgen suppression therapy&#xD;
&#xD;
          -  Serum testosterone at least 150 ng/dL at screening&#xD;
&#xD;
          -  WHO Performance Scale 0 to 3&#xD;
&#xD;
          -  Life expectancy of at least one year&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral orchiectomy&#xD;
&#xD;
          -  Prior androgen-ablative therapy within past year&#xD;
&#xD;
          -  Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer&#xD;
             or superficial bladder cancer)&#xD;
&#xD;
          -  Spinal cord compression&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Regulatory Division</last_name>
    <role>Study Director</role>
    <affiliation>Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)</affiliation>
  </overall_official>
  <results_reference>
    <citation>Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X.</citation>
    <PMID>16515997</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 13, 2011</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer, PSA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_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/NCT01697384
org study id: 301
nct id: NCT01697384
lead sponsor: 
has dmc: No
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant
      (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer
      during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified
      to eliminate the Lupron arm and continued the study as an open-label non-randomized study.

      Primary endpoint was testosterone suppression, as assessed by the percent of patients whose
      testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment
      with an implant.
Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments,
      eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety
      was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical
      examinations, and ECGs. Local tolerability outcomes were also evaluated.

      An extension period for the study included annual replacement of the implant until the
      implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during
      the extension period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
time frame: 52 weeks
measure: PSA measurements
time frame: 52 weeks
measure: Pain measurements
time frame: 52 weeks
measure: QoL outcomes
time frame: 52 weeks
arm group label: one histrelin acetate 50 mg implant
arm group type: Experimental
description: The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
intervention type: Drug
intervention name: histrelin acetate
description: 52 week implant
arm group label: one histrelin acetate 50 mg implant
other name: Vantas
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Regulatory Division
role: Study Director
affiliation: Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
citation: Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X.
PMID: 16515997
responsible party type: Sponsor
mesh term: Prostatic Neoplasms