Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Goserelin

Criteria

Key Inclusion Criteria:

• Male patients with histologically confirmed adenocarcinoma of the prostate

• Disease staging of M1 or apparent failure of the initial definitive therapy (e.g., prostatectomy, radiation, etc.), suggested by either an elevated PSA (5 ng/mL or greater within the previous 28 days), or when below 5ng/mL, rising PSA values (elevation from previous measurement greater than or equal to 0.1 ng/mL on three consecutive measurements at least two weeks apart with at least one of these measurements being within the last 28 days which may include the Screening Visit result, if needed)

• Clinically indicated for androgen suppression therapy

• Age 45 years or older

• Serum testosterone level of 150 ng/dL (5.25 nmol/L) or greater at screening

• PSA level of 5ng/mL or greater within the previous 28 days, or an increase in PSA (elevation from previous measurements greater than or equal to 0.1ng/mL on three consecutive measurements at least two weeks apart)

Key Exclusion Criteria:

• Bilateral orchiectomy

• Prior androgen-ablative or systemic corticosteroid therapy within the past year

• Second malignancy within five years, except adequately treated nonmelanomatous skin cancer or superficial bladder cancer

• Spinal cord compression

• Location of vertebral metastases that indicate risk of spinal cord compression during initial treatment period in the opinion of the Investigator

• Brain metastasis previously confirmed by CT scan