Back to resultsStudy 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
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, PSA
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
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
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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