A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220869
• Other study ID #: FE200486 CS43
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2010
• Last updated: December 6, 2013
• Start date: December 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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-a-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 Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
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	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi-Mei Foundation Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkuo	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No