Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
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.
Adenocarcinoma of the Prostate
Drug: histrelin acetate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer|
- Suppression of testosterone to chemical castration levels (<= 50 ng/dL) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- PSA measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Pain measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- QoL outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2000|
|Study Completion Date:||October 2004|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
Experimental: one histrelin acetate 50 mg implant
The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
Drug: histrelin acetate
52 week implant
Other Name: Vantas
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.