Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468286
• Other study ID #: FE200486 CS18
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2007
• Last updated: March 21, 2011
• Start date: May 2007
• Est. completion date: August 2008

Study information

• Verified date: March 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardRomania: Ministry of Public HealthRomania: National Medicines AgencyHungary: National Institute of PharmacyCzech Republic: Ethics CommitteeCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Description:

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion / Exclusion Criteria:

• Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.

• Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.

• Eastern Cooperative Oncology Group (ECOG) score of =2.

• Screening prostate-specific antigen (PSA) level = ng/mL.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
• Degarelix
Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.

Locations

Country	Name	City	State
Canada	Investigational site	Kentville	Nova Scotia
Canada	The Female/Male Health Centres	Ontario
Canada	Investigational site	Surrey	British Columbia
Canada	Investigational site	Victoria	British Columbia
Czech Republic	Nemocnice Jindrichuv Hradec a.s.	Hradec
Czech Republic	Slezska nemocnice	Opava
Czech Republic	Vseobecna fakultni nemocnice v Praze	Praha
Hungary	Dombóvári Szent Lukács Egészségügyi Kht	Dombovar
Hungary	Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ	Miskolc
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged
Romania	Private Medical Center	Arad
Romania	"Prof Dr Th Burghele" Clinical Hospital	Bucharest
Romania	Dinu Uromedica	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	E-Uro Medical Center S.R.L.	Cluj-Napoca
Romania	Provita Center	Constanta
Romania	Sibiu County Clinical Hospital	Sibiu
United States	South Florida Medical Research	Aventura	Florida
United States	Investigational site	Carmel	New York
United States	The Urology Center	Greensboro	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	South Orange County Medical Research Center	Laguna Woods	California
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Urology of Virginia Research	Norfolk	Virginia
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	Urology Research Center	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	State College Urologic Association	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Hungary,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of Testosterone at Castration Level (=0.5 ng/mL) From Day 28 Through Day 364	Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.	1 year	No
Secondary	Serum Levels of Testosterone Over Time		1 year	No
Secondary	Probability of Testosterone at Castration Level (=0.5 ng/mL) From Day 56 Through Day 364	Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.	1 year	No
Secondary	Probability of no PSA Failure	Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).	1 year	No
Secondary	Serum Levels of PSA Over Time		1 year	No
Secondary	Serum Levels of Follicle Stimulating Hormone (FSH) Over Time		1 year	No
Secondary	Serum Levels of Luteinizing Hormone (LH) Over Time		1 year	No
Secondary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.	Baseline up to 1 year	No
Secondary	Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	1 year	No