A Degarelix Trial in Patients With Prostate Cancer

Tracking Information
First Submitted Date ICMJE	November 16, 2010
First Posted Date ICMJE	November 17, 2010
Results First Submitted Date	February 26, 2015
Results First Posted Date	June 3, 2015
Last Update Posted Date	June 3, 2015
Study Start Date ICMJE	October 2010
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 13, 2015)	Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]; PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
Original Primary Outcome Measures ICMJE; (submitted: November 16, 2010)	PSA level [ Time Frame: Every 3 months during 27 months of treatment ]
Change History	Complete list of historical versions of study NCT01242748 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 13, 2015)	Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.; Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.; Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.; Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.; Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ]The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.; Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ]Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.; Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ]Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Original Secondary Outcome Measures ICMJE; (submitted: November 16, 2010)	Testosterone level [ Time Frame: Every three months during 27 months of treatment ]; Blood sample assessment [ Time Frame: Every 6 months during 27 months of treatment ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Degarelix Trial in Patients With Prostate Cancer
Official Title ICMJE	An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Brief Summary	A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Detailed Description	CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920). In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg). It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms). The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Drug: Degarelix The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. Other Names: Firmagon FE200486; Drug: Goserelin acetate The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. Other Name: Zoladex
Study Arms	Experimental: Degarelix 240 mg/480 mg Intervention: Drug: Degarelix; Active Comparator: Goserelin acetate Intervention: Drug: Goserelin acetate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: June 29, 2011)	288
Original Estimated Enrollment ICMJE; (submitted: November 16, 2010)	450
Actual Study Completion Date	January 2012
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).; Has completed the CS35 trial. Exclusion Criteria: Has been withdrawn from the CS35 trial.; Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Canada, Czech Republic, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Ukraine, United Kingdom, United States
Removed Location Countries	Russian Federation
Administrative Information
NCT Number ICMJE	NCT01242748
Other Study ID Numbers ICMJE	FE200486 CS35A; 2010-021434-55 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ferring Pharmaceuticals
Study Sponsor ICMJE	Ferring Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account	Ferring Pharmaceuticals
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP