Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
1 other identifier
interventional
138
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Apr 2000
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedJanuary 2, 2024
December 1, 2023
3.3 years
July 13, 2011
December 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
52 weeks
Secondary Outcomes (3)
PSA measurements
52 weeks
Pain measurements
52 weeks
QoL outcomes
52 weeks
Study Arms (1)
one histrelin acetate 50 mg implant
EXPERIMENTALThe test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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: 16515997RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Regulatory Division
Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
October 2, 2012
Study Start
April 1, 2000
Primary Completion
August 1, 2003
Study Completion
October 1, 2004
Last Updated
January 2, 2024
Record last verified: 2023-12