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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00295750
First received: February 22, 2006
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Leuprolide 7.5 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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).

  • Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.

  • Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 [ Time Frame: Day 252, Day 255, and Day 259 ] [ Designated as safety issue: No ]
    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.

  • Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 [ Time Frame: Days 14 and 28 ] [ Designated as safety issue: No ]
    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.

  • Participants Grouped by Time to Prostate-specific Antigen Failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) [ Time Frame: Baseline to Day 364 ] [ Designated as safety issue: No ]
    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.

  • The Mean Value of QTc Interval as Measured by Electrocardiogram [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 620
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: degarelix 240/160 mg
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.
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.
Other Name: FE200486
Experimental: degarelix 240/80 mg
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.
Drug: 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.
Other Name: FE 200486
Active Comparator: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Drug: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Other Name: Lupron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295750

  Show 35 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications:
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00295750     History of Changes
Other Study ID Numbers: FE200486 CS21
Study First Received: February 22, 2006
Results First Received: January 5, 2009
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014