A Study of Degarelix in Taiwanese Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

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

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

Inclusion Criteria:

• 20 years or older

• Has a histological confirmed prostate cancer

• Has a screening serum testosterone above 1.5 ng/mL

• Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2

• Has a screening PSA value of ≥2 ng/mL

• Has a life expectancy of at least 168 days

Exclusion Criteria:

• Current or previous hormone therapy

• Is currently treated with 5-α-reductase inhibitor

• Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema

• Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy

• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.

• Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator

• Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial