Phase III, Open-Label Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Metastatic Prostate Cancer
Sponsor study identifier
interventional
59
0 countries
N/A
Study Start
May 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2001
Actual (reported)Study Completion
December 2003
Actual (reported)This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2003
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.
May 2000
Date type not reportedThis date has not been verified as actual or estimated.
December 2001
Actual (reported)December 2003
Actual (reported)July 13, 2011
Actual (reported)July 14, 2011
Actual (reported)Suppression of testosterone via the percent of patients whose testosterone was at or below chemical castration levels (<=50 n/dL) through 52 weeks of treatment.
52 weeks
Secondary efficacy was assessed by serum LH, PSA, and PAP, WHO Performance Status, Pain Level assessment, the National Prostatic Cancer Project (NPCP) assessment for objective clinical status, PSA status, time to disease progression, and QoL.
52 weeks
Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall.
Histrelin hydrogel implant, 3 cm x 3.5 mm, containing 50 mg of histrelin acetate, surgically placed subdermally into the inner aspect of the upper arm.
50 mg histrelin acetate in hyrogel implant
goserelin implant injection.
59 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2011
First Posted
July 14, 2011
Study Start
May 2000
Date type not reportedThis date has not been verified as actual or estimated.
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2001
Actual (reported)Study Completion
December 2003
Actual (reported)Last Updated
January 2, 2024
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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