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Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

Primary Purpose

Prostate Cancer, Adenocarcinoma of the Prostate

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
histrelin acetate
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, PSA

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male Age 45 or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Disease Staging III or IV
  • Clinical indication for androgen suppression therapy
  • Serum testosterone at least 150 ng/dL at screening
  • WHO Performance Scale 0 to 3
  • Life expectancy of at least one year

Key Exclusion Criteria:

  • Bilateral orchiectomy
  • Prior androgen-ablative therapy within past year
  • Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
  • Spinal cord compression

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    one histrelin acetate 50 mg implant

    Arm Description

    The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.

    Outcomes

    Primary Outcome Measures

    Suppression of testosterone to chemical castration levels (<= 50 ng/dL)

    Secondary Outcome Measures

    PSA measurements
    Pain measurements
    QoL outcomes

    Full Information

    First Posted
    July 13, 2011
    Last Updated
    September 27, 2012
    Sponsor
    Endo Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01697384
    Brief Title
    Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
    Official Title
    Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2000 (undefined)
    Primary Completion Date
    August 2003 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Endo Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Adenocarcinoma of the Prostate
    Keywords
    prostate cancer, PSA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    138 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    one histrelin acetate 50 mg implant
    Arm Type
    Experimental
    Arm 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(s)
    histrelin acetate
    Other Intervention Name(s)
    Vantas
    Intervention Description
    52 week implant
    Primary Outcome Measure Information:
    Title
    Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    PSA measurements
    Time Frame
    52 weeks
    Title
    Pain measurements
    Time Frame
    52 weeks
    Title
    QoL outcomes
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Male Age 45 or older Histologically confirmed adenocarcinoma of the prostate Disease Staging III or IV Clinical indication for androgen suppression therapy Serum testosterone at least 150 ng/dL at screening WHO Performance Scale 0 to 3 Life expectancy of at least one year Key Exclusion Criteria: Bilateral orchiectomy Prior androgen-ablative therapy within past year Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer) Spinal cord compression
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Regulatory Division
    Organizational Affiliation
    Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16515997
    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.
    Results Reference
    result

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    Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

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