A Study of Degarelix in Taiwanese Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01220869
First received: October 13, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 [ Time Frame: From Day 28 to Day 168 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Day 0 to Day 28 ] [ Designated as safety issue: No ]
    Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28

  • Cumulative Probability of no PSA Failure [ Time Frame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis [ Time Frame: From Day 28 to Day 168 ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • degarelix acetate
  • Firmagon
  • FE200486

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220869

Locations
Taiwan
Changhua Christian Hospital
Changhua City, Taiwan
Chang Gung Medical Foundation, Chiayi Branch
Chiayi, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chi-Mei Foundation Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkuo
Taoyuan, Taiwan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01220869     History of Changes
Other Study ID Numbers: FE200486 CS43
Study First Received: October 13, 2010
Results First Received: October 14, 2013
Last Updated: December 6, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014