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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals

Criteria

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