The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295750
• Other study ID #: FE200486 CS21
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2006
• Last updated: December 17, 2012
• Start date: February 2006
• Est. completion date: October 2007

Study information

• Verified date: December 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study was a three-arm, active-control, multi-centre, parallel group study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

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

• Baseline testosterone >1.5 ng/mL.

• Life expectancy of at least 12 months.

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
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
• Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
• Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.

Locations

Country	Name	City	State
Canada	Bruce W. Palmer Urology Inc, 125-70 Exhibition Street	Kentville	Nova Scotia
Czech Republic	Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III	Jindrichuv Hradec
Germany	Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3	Mannheim
Hungary	Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57	Szeged
Mexico	Hospital General "Dr Santiago Ramon y Cajal", ISSSTE	Predio Canoas S/N	Durango, DGO
Netherlands	Atrium MC, Henri Dunantstraat 5	Heerlen
Puerto Rico	Cristo Redentor Hospital	La Hacienda
Puerto Rico	San Juan VA Medical Center	San Juan
Romania	Provita Center, 2 Primaverii Street	Constanta
Russian Federation	Andros Urology Clinic, Ulitsa Lenina 36A	St Petersburg
Ukraine	Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.	Kiev
United Kingdom	Derriford Hospital, Derriford Road	Plymouth
United States	Advanced Urology Medical Center	Anaheim	California
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	South Florida Medical Research	Aventura	Florida
United States	Pacific Clinical Center	Beverly Hills	California
United States	Jay A. Motola, MD, FACS	Carmel	New York
United States	Northeast Urology Research	Concord	North Carolina
United States	University of Colorado	Denver	Colorado
United States	Urology Associate PC	Denver	Colorado
United States	Simi-San Faernando Valley Urology Associates	Granada Hills	California
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	Lawrenceville Urology	Lawrenceville	New Jersey
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	Univeristy Urological Research Institute	Providence	Rhode Island
United States	University Urological Research Institute	Providence	Rhode Island
United States	Urology San Antonio Research	San Antonio	Texas
United States	Office of Jeffrey Frankel	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	State College Urologic Association	State College	Pennsylvania
United States	Western Clinical Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  Mexico,  Netherlands,  Puerto Rico,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

References & Publications (1)

Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Testosterone <=0.5ng/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. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.	12 months	No
Secondary	Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment	A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).	2 weeks	No
Secondary	Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3	This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.	3 days	No
Secondary	Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252	Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.	Day 252, Day 255, and Day 259	No
Secondary	Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28	Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.	Days 14 and 28	No
Secondary	Participants Grouped by Time to Prostate-specific Antigen Failure	The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of =50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.	12 months	No
Secondary	Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)	Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.	Baseline to Day 364	No
Secondary	The Mean Value of QTc Interval as Measured by Electrocardiogram	The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.	12 months	No
Secondary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.	12 months	No