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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix
Degarelix
Leuprolide 7.5 mg
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Centers of Alabama
  • Alaska Clinical Research Center, LLC
  • Advanced Urology Medical Center
  • Pacific Clinical Center
  • Simi-San Faernando Valley Urology Associates
  • South Orange County Medical Research Center
  • Western Clinical Research
  • Urology Associate PC
  • University of Colorado
  • South Florida Medical Research
  • Florida Foundation for Healthcare Research
  • Regional Urology
  • Lawrenceville Urology
  • Jay A. Motola, MD, FACS
  • Northeast Urology Research
  • The Urology Center
  • State College Urologic Association
  • Univeristy Urological Research Institute
  • University Urological Research Institute
  • Grand Strand Urology
  • Urology San Antonio Research
  • Urology of Virginia Research
  • Office of Jeffrey Frankel
  • Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
  • Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
  • Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
  • Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
  • Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
  • Atrium MC, Henri Dunantstraat 5
  • Cristo Redentor Hospital
  • San Juan VA Medical Center
  • Provita Center, 2 Primaverii Street
  • Andros Urology Clinic, Ulitsa Lenina 36A
  • Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
  • Derriford Hospital, Derriford Road

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

degarelix 240/160 mg

degarelix 240/80 mg

Leuprolide 7.5 mg

Arm Description

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.

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.

Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 22, 2006
Last Updated
December 17, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00295750
Brief Title
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
degarelix 240/160 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
degarelix 240/80 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Leuprolide 7.5 mg
Arm Type
Active Comparator
Arm Description
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE 200486
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Leuprolide 7.5 mg
Other Intervention Name(s)
Lupron
Intervention Description
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Primary Outcome Measure Information:
Title
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Description
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%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
Description
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).
Time Frame
2 weeks
Title
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
Description
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Time Frame
3 days
Title
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Description
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.
Time Frame
Day 252, Day 255, and Day 259
Title
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Description
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.
Time Frame
Days 14 and 28
Title
Participants Grouped by Time to Prostate-specific Antigen Failure
Description
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.
Time Frame
12 months
Title
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Description
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.
Time Frame
Baseline to Day 364
Title
The Mean Value of QTc Interval as Measured by Electrocardiogram
Description
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.
Time Frame
12 months
Title
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Advanced Urology Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pacific Clinical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Simi-San Faernando Valley Urology Associates
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Woods,
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Western Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Associate PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Jay A. Motola, MD, FACS
City
Carmel
State/Province
New York
ZIP/Postal Code
10512
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
State College Urologic Association
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Univeristy Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Urology of Virginia Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Office of Jeffrey Frankel
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4KB
Country
Canada
Facility Name
Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
City
Jindrichuv Hradec
ZIP/Postal Code
37738
Country
Czech Republic
Facility Name
Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
City
Predio Canoas S/N
State/Province
Durango, DGO
ZIP/Postal Code
34079
Country
Mexico
Facility Name
Atrium MC, Henri Dunantstraat 5
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Cristo Redentor Hospital
City
La Hacienda
ZIP/Postal Code
00784
Country
Puerto Rico
Facility Name
San Juan VA Medical Center
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Provita Center, 2 Primaverii Street
City
Constanta
ZIP/Postal Code
900635
Country
Romania
Facility Name
Andros Urology Clinic, Ulitsa Lenina 36A
City
St Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
Facility Name
Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
City
Kiev
ZIP/Postal Code
2125
Country
Ukraine
Facility Name
Derriford Hospital, Derriford Road
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19035858
Citation
Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
Results Reference
result
PubMed Identifier
34350976
Citation
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Results Reference
derived

Learn more about this trial

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

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