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Completed

NCT Number: NCT01220869

A Study of Degarelix in Taiwanese Patients With Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Changhua Christian Hospital, Changhua, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

degarelix

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).

Other names: degarelix acetate, Firmagon, FE200486

Primary outcomes

  1. 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

    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 outcomes

  1. Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3

    Time frame: Day 3

    Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3

  2. Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28

    Time frame: From Day 0 to Day 28

    Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28

  3. Cumulative Probability of no PSA Failure

    Time frame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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