Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
Sponsor study identifier
interventional
138
0 countries
N/A
Study Start
April 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2003
Actual (reported)Study Completion
October 2004
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2000
Date type not reportedThis date has not been verified as actual or estimated.
August 2003
Actual (reported)October 2004
Actual (reported)July 13, 2011
Actual (reported)October 2, 2012
Actual (reported)Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
52 weeks
PSA measurements
52 weeks
Pain measurements
52 weeks
QoL outcomes
52 weeks
The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
52 week implant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Regulatory Division
Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
138 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2011
First Posted
October 2, 2012
Study Start
April 2000
Date type not reportedThis date has not been verified as actual or estimated.
Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Contact the study team to confirm eligibility.
Primary Completion
August 2003
Actual (reported)Study Completion
October 2004
Actual (reported)Last Updated
January 2, 2024
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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