Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of Degarelix in Taiwanese Patients With Prostate Cancer

NCTNCT01220869Other idFE200486 CS43

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 110 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Taiwan
Start: Dec 2010
Primary completion: Oct 2012
Completion: Oct 2012
First posted: 14 Oct 2010 (estimated)
Last update posted: 13 Apr 2025
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201120122013

Ph 3
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
NCT01220869
Dec 2010 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

DegarelixDrug

Arms1

Experimental
Degarelix

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry 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.

Secondary outcomes(3)

Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Time frame · Day 3
Registry description
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
Registry description
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
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From Day 28 to Day 168

Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168

Group	Value (Percentage of participants)
Degarelix	97.2

Secondary and other outcome results(4)

Secondary outcomeMean· Day 3

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

Group	Value (Percentage of participants)
Degarelix	93.5

Secondary outcomeMedian· From Day 0 to Day 28

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

Group	Value (Percentage change of PSA)
Degarelix	-92.4

Other pre specified outcomeMean· From Day 28 to Day 168

Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis

Group	Value (Percentage of participants)
Degarelix	97.2

Secondary outcomeMean· Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

Cumulative Probability of no PSA Failure

Group	Value (Percentage of participants)
Degarelix	100

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
DegarelixDegarelix 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).	–	9 / 110	69 / 110

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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