A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Degarelix

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).

Interventions

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Degarelix

Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).

Intervention Type DRUG

Other Intervention Names

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degarelix acetate Firmagon FE200486

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No