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Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
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 Hormone refractory prostate cancer, Agonist treatment failure

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has given written informed consent before any trial-related activity is performed.
  • Patient is 18 years or older.
  • Histologically confirmed prostate cancer.
  • Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
  • Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
  • Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Estimated life expectancy at least 12 months.

Exclusion Criteria:

  • Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
  • Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
  • Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
  • Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
  • Known hypersensitivity towards any component of the investigational medical product.
  • History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Known or suspected clinically significant liver and/or biliary disease.
  • Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
  • Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
  • Previous participation in any degarelix trial.

Sites / Locations

  • Urologische Praxis
  • Urologische Klinik
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Martini Klinik
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Klinik
  • Wissenschaftskontor Nord

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Outcomes

Primary Outcome Measures

Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level

Secondary Outcome Measures

Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level. Per protocol, the two month timeframe was only analyzed for cohort 2.
Participants at Testosterone Castrate Level Throughout the Study
Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
Change From Baseline in Serum Levels of Testosterone at the Last Visit
Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
LH is measured in IU/L
Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.
Kaplan-Meier Estimate for Overall Survival
The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

Full Information

First Posted
August 18, 2008
Last Updated
December 12, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00738673
Brief Title
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Official Title
An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone refractory prostate cancer, Agonist treatment failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Arm Description
Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).
Primary Outcome Measure Information:
Title
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
Description
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level
Time Frame
Day 0 (baseline), 3 months
Secondary Outcome Measure Information:
Title
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
Description
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.
Time Frame
Day 0 (baseline), 1 month
Title
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
Description
Response to treatment was defined as: Response (stabilisation or decrease): Difference ≤ +10% of Baseline level No response (increase): Difference > +10% of Baseline level. Per protocol, the two month timeframe was only analyzed for cohort 2.
Time Frame
Day 0 (baseline), 2 months
Title
Participants at Testosterone Castrate Level Throughout the Study
Description
Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
Time Frame
up to month 12
Title
Change From Baseline in Serum Levels of Testosterone at the Last Visit
Time Frame
Day 0 (baseline), up to month 12 (last visit)
Title
Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
Time Frame
Day 0 (baseline), up to month 12 (last visit)
Title
Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
Description
LH is measured in IU/L
Time Frame
Day 0 (baseline), up to month 12 (last visit)
Title
Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
Time Frame
Day 0 (baseline), up to month 12 (last visit)
Title
Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
Description
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
Time Frame
up to month 12
Title
Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
Description
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
Time Frame
up to month 12
Title
Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
Description
Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.
Time Frame
up to month 12
Title
Kaplan-Meier Estimate for Overall Survival
Description
The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.
Time Frame
up to month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has given written informed consent before any trial-related activity is performed. Patient is 18 years or older. Histologically confirmed prostate cancer. Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due). Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months. Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Estimated life expectancy at least 12 months. Exclusion Criteria: Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years. Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1). Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication. Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer. Known hypersensitivity towards any component of the investigational medical product. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. Known or suspected clinically significant liver and/or biliary disease. Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator. Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator. Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation. Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial. Previous participation in any degarelix trial.
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
Urologische Praxis
City
Bautzen
Country
Germany
Facility Name
Urologische Klinik
City
Berlin
Country
Germany
Facility Name
Urologische Praxis
City
Berlin
Country
Germany
Facility Name
Urologische Praxis
City
Borken
Country
Germany
Facility Name
Urologische Praxis
City
Erkrath - Hochdal
Country
Germany
Facility Name
Urologische Praxis
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
Facility Name
Martini Klinik
City
Hamburg
Country
Germany
Facility Name
Urologische Praxis
City
Husum
Country
Germany
Facility Name
Urologische Praxis
City
Kirchheim
Country
Germany
Facility Name
Urologische Praxis
City
Köln
Country
Germany
Facility Name
Urologische Praxis
City
Lauenburg/Elbe
Country
Germany
Facility Name
Urologische Praxis
City
Leipzig
Country
Germany
Facility Name
Urologische Praxis
City
Markkleeberg
Country
Germany
Facility Name
Urologische Klinik
City
Planegg
Country
Germany
Facility Name
Wissenschaftskontor Nord
City
Rostock
Country
Germany

12. IPD Sharing Statement

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Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

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