A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220869

FE200486 CS43

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Degarelix

Experimental group

Treatment:

Drug: Degarelix