search
Back to results

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
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

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent prior to any study related procedures
  • Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
  • Hypersensitivity towards any component of degarelix or mannitol
  • Cancer disease within the last 5 years except for prostate cancer and some skin cancers
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Known hepatic disease
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier precluding adequate understanding or cooperation
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial

Sites / Locations

  • UCL Saint Luc
  • UZ Gent
  • UZ Gasthuisberg
  • Vivantes Klinikum am Urban
  • Loretto Krankenhaus
  • Euromed AG Klinik
  • Urologische Universitätsklinikum
  • Bajcsy-Zsilinszky Hospital, Urology
  • Jahn Ferenc Dél Pesti Hospital, Urology
  • Pez Aladar County Hospital
  • BAZ County Hospital
  • Hospital of Local Gov. Szeged, Urology
  • MÁV Hospital, Urology
  • AMC
  • Atrium MC
  • Wojewódzki Szpital Specjalisttyczny
  • Wojewódzki Szpital Specjalisttyczny
  • CF2 Hospital
  • Dr. Th Burghele Hospital
  • Fundeni Hospital
  • Sf. Ioan Hospital
  • Botkin Clinical Hospital
  • City Hospital #1
  • City Hospital #29
  • City Hospital #50
  • City Hospital #60
  • Institute of Urology of MoH
  • "Andros" Urology Clinic
  • City Hospital #15
  • City Hospital #26
  • Military Medical Academy, Urology
  • Pavlov Medical School Outpatient
  • Pavlov medical School, Urology
  • Sct Petersburg State Medical Academy
  • 370 Clarke Road
  • Pretoria Urology Hospital
  • WITS Medical School
  • 401B Medical Centre
  • Sunninghill Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Degarelix 200/80

Degarelix 200/120

Degarelix 200/160

Degarelix 240/80

Degarelix 240/120

Degarelix 240/160

Arm Description

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Outcomes

Primary Outcome Measures

Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Number of patients who achieved a testosterone level considered a castration level.

Secondary Outcome Measures

Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Days to 50 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
Days to 90 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
Days to Prostate-Specific Antigen Progression
Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Median Serum Testosterone Levels
Median Prostate-specific Antigen Levels
Median Values of Di-Hydrotestosterone
Median Values for Serum Luteinizing Hormone
Median Values for Follicle Stimulation Hormone
The Number of Patients With Abnormal Liver Function Tests
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

Full Information

First Posted
January 7, 2009
Last Updated
December 20, 2011
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00819156
Brief Title
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Official Title
An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2005 (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 purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 200/80
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Arm Title
Degarelix 200/120
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Arm Title
Degarelix 200/160
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Arm Title
Degarelix 240/80
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Arm Title
Degarelix 240/120
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Arm Title
Degarelix 240/160
Arm Type
Experimental
Arm Description
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix was given as subcutaneous injections.
Primary Outcome Measure Information:
Title
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Description
Number of patients who achieved a testosterone level considered a castration level.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
Description
Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Time Frame
Day 28 - 364
Title
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
Description
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Time Frame
Day 28
Title
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
Description
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Time Frame
Day 3
Title
Days to 50 Percent Reduction in Prostate-Specific Antigen
Description
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
Time Frame
Day 0 (post dose) to Day 364
Title
Days to 90 Percent Reduction in Prostate-Specific Antigen
Description
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
Time Frame
Day 0 (post dose) to Day 364
Title
Days to Prostate-Specific Antigen Progression
Description
Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Time Frame
Day 0 (post dose) to Day 364
Title
Median Serum Testosterone Levels
Time Frame
Day 0 (Baseline), Days 1,3,7,14, and 364
Title
Median Prostate-specific Antigen Levels
Time Frame
Day 0 (Baseline), Days 3, 7, 14, and 364
Title
Median Values of Di-Hydrotestosterone
Time Frame
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Title
Median Values for Serum Luteinizing Hormone
Time Frame
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Title
Median Values for Follicle Stimulation Hormone
Time Frame
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Title
The Number of Patients With Abnormal Liver Function Tests
Description
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
Time Frame
364 days
Title
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Description
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
Time Frame
Day 364

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent prior to any study related procedures Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy ECOG score to be equal to or above 2 Testosterone level within age-specific normal range PSA value equal to or above 2 ng/ml Life expectancy of at least 6 months Exclusion Criteria: Previous or current hormonal treatment of prostate cancer Recent or current treatment with any drugs modifying the testosterone level Candidate for curative treatment such as prostatectomy or radiotherapy History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema Hypersensitivity towards any component of degarelix or mannitol Cancer disease within the last 5 years except for prostate cancer and some skin cancers Signs of liver impairment shown as elevated serum ALT or serum bilirubin Known hepatic disease Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator Mental incapacity or language barrier precluding adequate understanding or cooperation Having received an investigational product within the last 12 weeks preceding the trial Previous participation in this 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
UCL Saint Luc
City
Brussels
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Vivantes Klinikum am Urban
City
Berlin
Country
Germany
Facility Name
Loretto Krankenhaus
City
Freiburg
Country
Germany
Facility Name
Euromed AG Klinik
City
Fürth
Country
Germany
Facility Name
Urologische Universitätsklinikum
City
Mannheim
Country
Germany
Facility Name
Bajcsy-Zsilinszky Hospital, Urology
City
Budapest
Country
Hungary
Facility Name
Jahn Ferenc Dél Pesti Hospital, Urology
City
Budapest
Country
Hungary
Facility Name
Pez Aladar County Hospital
City
Györ
Country
Hungary
Facility Name
BAZ County Hospital
City
Miskolc
Country
Hungary
Facility Name
Hospital of Local Gov. Szeged, Urology
City
Szeged
Country
Hungary
Facility Name
MÁV Hospital, Urology
City
Szolnok
Country
Hungary
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
Atrium MC
City
Heerlen
Country
Netherlands
Facility Name
Wojewódzki Szpital Specjalisttyczny
City
Siedlce
Country
Poland
Facility Name
Wojewódzki Szpital Specjalisttyczny
City
Slupsk
Country
Poland
Facility Name
CF2 Hospital
City
Bucharest
Country
Romania
Facility Name
Dr. Th Burghele Hospital
City
Bucharest
Country
Romania
Facility Name
Fundeni Hospital
City
Bucharest
Country
Romania
Facility Name
Sf. Ioan Hospital
City
Bucharest
Country
Romania
Facility Name
Botkin Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #1
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #29
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #50
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #60
City
Moscow
Country
Russian Federation
Facility Name
Institute of Urology of MoH
City
Moscow
Country
Russian Federation
Facility Name
"Andros" Urology Clinic
City
St Petersburg
Country
Russian Federation
Facility Name
City Hospital #15
City
St Petersburg
Country
Russian Federation
Facility Name
City Hospital #26
City
St Petersburg
Country
Russian Federation
Facility Name
Military Medical Academy, Urology
City
St Petersburg
Country
Russian Federation
Facility Name
Pavlov Medical School Outpatient
City
St Petersburg
Country
Russian Federation
Facility Name
Pavlov medical School, Urology
City
St Petersburg
Country
Russian Federation
Facility Name
Sct Petersburg State Medical Academy
City
St Petersburg
Country
Russian Federation
Facility Name
370 Clarke Road
City
Glenwood, Durban
Country
South Africa
Facility Name
Pretoria Urology Hospital
City
Hatfield, Pretoria
Country
South Africa
Facility Name
WITS Medical School
City
Parktown
Country
South Africa
Facility Name
401B Medical Centre
City
Pietermaritzburg
Country
South Africa
Facility Name
Sunninghill Clinic
City
Sunninghill
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
18538469
Citation
Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.
Results Reference
result

Learn more about this trial

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

We'll reach out to this number within 24 hrs