CompletedPhase 3

Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

138 participantsStarted 2000-04

Plain-language 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.

Who can participate

Age range45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Suppression of testosterone to chemical castration levels (<= 50 ng/dL)

Timeframe: 52 weeks

Trial details

NCT IDNCT01697384

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-08

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