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A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
October 13, 2010
Last Updated
December 6, 2013
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01220869
Brief Title
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
degarelix acetate, Firmagon, FE200486
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
Description
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.
Time Frame
From Day 28 to Day 168
Secondary Outcome Measure Information:
Title
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Description
Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3
Time Frame
Day 3
Title
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
Description
Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28
Time Frame
From Day 0 to Day 28
Title
Cumulative Probability of no PSA Failure
Description
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.
Time Frame
Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168
Other Pre-specified Outcome Measures:
Title
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis
Description
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.
Time Frame
From Day 28 to Day 168

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua City
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Chiayi Branch
City
Chiayi
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi-Mei Foundation Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkuo
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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A Study of Degarelix in Taiwanese Patients With Prostate Cancer

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