A Study of Degarelix in Taiwanese Patients With Prostate Cancer

An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Changhua City, Taiwan
    • Changhua Christian Hospital
  • Chiayi, Taiwan
    • Chang Gung Medical Foundation, Chiayi Branch
  • Kaohsiung, Taiwan
    • Chang Gung Memorial Hospital, Kaohsiung
  • Kaohsiung, Taiwan
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Tainan, Taiwan
    • Chi-Mei Foundation Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital, Linkuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix	Drug: 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).; Other Names: Firmagon; FE200486; degarelix acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168	Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.	From Day 28 to Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3	Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3	Day 3
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28	Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28	From Day 0 to Day 28
Cumulative Probability of no PSA Failure	The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.	Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis	Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.	From Day 28 to Day 168

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS43