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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Degarelix
Degarelix
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

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.

Sites / Locations

  • Urology Centers of Alabama
  • South Orange County Medical Research Center
  • South Florida Medical Research
  • Florida Foundation for Healthcare Research
  • Regional Urology
  • Investigational site
  • The Urology Center
  • State College Urologic Association
  • Grand Strand Urology
  • Urology of Virginia Research
  • Urology Research Center
  • Investigational site
  • Investigational site
  • Investigational site
  • The Female/Male Health Centres
  • Nemocnice Jindrichuv Hradec a.s.
  • Slezska nemocnice
  • Vseobecna fakultni nemocnice v Praze
  • Dombóvári Szent Lukács Egészségügyi Kht
  • Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
  • Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Private Medical Center
  • "Prof Dr Th Burghele" Clinical Hospital
  • Dinu Uromedica
  • Fundeni Clinical Institute
  • E-Uro Medical Center S.R.L.
  • Provita Center
  • Sibiu County Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Treatment group A: 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.

Treatment group B: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum Levels of Testosterone Over Time
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.
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).
Serum Levels of PSA Over Time
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
Serum Levels of Luteinizing Hormone (LH) Over Time
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.
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.

Full Information

First Posted
April 13, 2007
Last Updated
March 21, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00468286
Brief Title
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Treatment group A: 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.
Arm Title
B
Arm Type
Experimental
Arm Description
Treatment group B: 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.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Probability of Testosterone at Castration Level (≤0.5 ng/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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Serum Levels of Testosterone Over Time
Time Frame
1 year
Title
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364
Description
Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.
Time Frame
1 year
Title
Probability of no PSA Failure
Description
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).
Time Frame
1 year
Title
Serum Levels of PSA Over Time
Time Frame
1 year
Title
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
Time Frame
1 year
Title
Serum Levels of Luteinizing Hormone (LH) Over Time
Time Frame
1 year
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
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.
Time Frame
Baseline up to 1 year
Title
Liver Function Tests
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92653
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
Investigational site
City
Carmel
State/Province
New York
ZIP/Postal Code
10512
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
State College Urologic Association
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
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 of Virginia Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Urology Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Investigational site
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Investigational site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Investigational site
City
Kentville
State/Province
Nova Scotia
Country
Canada
Facility Name
The Female/Male Health Centres
City
Ontario
Country
Canada
Facility Name
Nemocnice Jindrichuv Hradec a.s.
City
Hradec
Country
Czech Republic
Facility Name
Slezska nemocnice
City
Opava
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha
Country
Czech Republic
Facility Name
Dombóvári Szent Lukács Egészségügyi Kht
City
Dombovar
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Facility Name
Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
City
Miskolc
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
Country
Hungary
Facility Name
Private Medical Center
City
Arad
Country
Romania
Facility Name
"Prof Dr Th Burghele" Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Dinu Uromedica
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
E-Uro Medical Center S.R.L.
City
Cluj-Napoca
Country
Romania
Facility Name
Provita Center
City
Constanta
Country
Romania
Facility Name
Sibiu County Clinical Hospital
City
Sibiu
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

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

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