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Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix
Goserelin
Bicalutamide
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:

  1. Patient has given written informed consent
  2. Patient is 18 years or older
  3. Patient has histologically confirmed prostate cancer
  4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL
  5. The prostate size is >30 cubic centimetres (cc), measured by TRUS
  6. Patient has had a bone-scan within 12 weeks before inclusion
  7. Patient must be able to undergo transrectal examinations
  8. Patient has an estimated life expectancy of at least 12 months

Exclusion Criteria:

  1. Any previous treatments for prostate cancer
  2. Previous trans-urethral resection of the prostate (TURP)
  3. Is not considered a candidate for medical castration
  4. Use of urethral catheter
  5. Is currently treated with a 5-alpha reductase inhibitor
  6. Is currently treated with an alpha-adrenoceptor antagonist
  7. Treatment with botulinum toxin A (Botox)
  8. Require radiotherapy during the trial
  9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
  10. Hypersensitivity towards any component of the investigational products or excipients
  11. Previous history or presence of another malignancy
  12. A clinically significant disorder
  13. A corrected QT interval over 450 msec
  14. Mental incapacity or language barrier precluding adequate understanding or co-operation
  15. Receipt of an investigational drug within the last 28 days proceeding screening
  16. Previous participation in any degarelix trial

Sites / Locations

  • Hospital St Jan Brugge
  • Institut Jules Bordet
  • University Hospitals Leuven
  • St. Elisabethziekenhuis
  • Aalborg Sygehus syd
  • Herlev Hospital
  • Regionhospitalet Holstebro
  • Sygehus Syd, Næstved Sygehus
  • Roskilde Sygehus
  • Århus Universitetshospital, Skejby
  • HYKS/kirurgian klin./urologia
  • KYS/kirurgian klin (Kuopio)
  • OYS/kirurgian klinik
  • TAYS/kirurgian klinik
  • Azienda Ospedaliero Universitaria Ospedali riuniti
  • Azienda Ospedaliera S. Giuseppe Moscaaati
  • Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
  • U.O. Di Urologia - Spedali Civili di Brescia
  • Clinica Urologica 1 Universita. Firensa
  • Fondazione IRCCS Istituto Nazionale Tumori
  • Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
  • Clinica Urologica - Azienda Ospedaliera di Perugia
  • Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
  • S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
  • Moelv spesialistsenter
  • Aker Universitetssykehus HF
  • Det Norske Radiumhospitalet HF
  • St Olavs Hospital HF
  • Hospital Fernando da Fonseca
  • Hospitais Universidade Coimbra
  • Centro Hospitalar Lisboa Norte, Hospital Santa Maria
  • Hospital S.João
  • Investigational site
  • SU/Sahlgrenska
  • Helsingborgs Lasarett
  • Universitetssjukhuset MAS
  • Södertälje Sjukhus
  • Uppsala/Akademiska sjukhuset
  • Cerrahpasa Faculty of Medicine, Kocamustafapasa
  • Istanbul University Faculty of Medicine, ÇAPA
  • Marmara University Faculty of Medicine, Altunizade
  • Ankara University Faculty of Medicine
  • Hacettepe University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Degarelix 240 mg/80 mg

Goserelin (3.6 mg) + bicalutamide (50 mg)

Arm Description

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Outcomes

Primary Outcome Measures

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
TRUS is a method of measuring the size of the prostate.

Secondary Outcome Measures

Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Change in Serum Testosterone Levels During the Study
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

Full Information

First Posted
April 17, 2009
Last Updated
October 21, 2013
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00884273
Brief Title
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Official Title
A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 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 a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 240 mg/80 mg
Arm Type
Experimental
Arm Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Arm Title
Goserelin (3.6 mg) + bicalutamide (50 mg)
Arm Type
Active Comparator
Arm Description
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486, FIRMAGON
Intervention Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
ZOLADEX
Intervention Description
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
CASODEX
Intervention Description
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
Primary Outcome Measure Information:
Title
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Description
TRUS is a method of measuring the size of the prostate.
Time Frame
After treatment of 12 weeks compared to Baseline
Title
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
Description
TRUS is a method of measuring the size of the prostate.
Time Frame
After treatment of 12 weeks compared to Baseline
Secondary Outcome Measure Information:
Title
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
Description
TRUS is a method of measuring the size of the prostate.
Time Frame
After treatment of 4 and 8 weeks compared to Baseline
Title
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Description
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change in Serum Testosterone Levels During the Study
Time Frame
At 4, 8, and 12 weeks compared to baseline.
Title
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time Frame
At 4, 8, and 12 weeks compared to baseline.
Title
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
Description
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
Description
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.
Time Frame
After treatment of 4, 8, and 12 weeks compared to Baseline
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time Frame
Baseline to 12 weeks of treatment
Title
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame
Baseline to 12 weeks of treatment

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 Patient is 18 years or older Patient has histologically confirmed prostate cancer Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL The prostate size is >30 cubic centimetres (cc), measured by TRUS Patient has had a bone-scan within 12 weeks before inclusion Patient must be able to undergo transrectal examinations Patient has an estimated life expectancy of at least 12 months Exclusion Criteria: Any previous treatments for prostate cancer Previous trans-urethral resection of the prostate (TURP) Is not considered a candidate for medical castration Use of urethral catheter Is currently treated with a 5-alpha reductase inhibitor Is currently treated with an alpha-adrenoceptor antagonist Treatment with botulinum toxin A (Botox) Require radiotherapy during the trial History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema Hypersensitivity towards any component of the investigational products or excipients Previous history or presence of another malignancy A clinically significant disorder A corrected QT interval over 450 msec Mental incapacity or language barrier precluding adequate understanding or co-operation Receipt of an investigational drug within the last 28 days proceeding screening 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
Hospital St Jan Brugge
City
Brugge
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
St. Elisabethziekenhuis
City
Turnhout
Country
Belgium
Facility Name
Aalborg Sygehus syd
City
Aalborg
Country
Denmark
Facility Name
Herlev Hospital
City
Ballerup
Country
Denmark
Facility Name
Regionhospitalet Holstebro
City
Holstebro
Country
Denmark
Facility Name
Sygehus Syd, Næstved Sygehus
City
Næstved
Country
Denmark
Facility Name
Roskilde Sygehus
City
Roskilde
Country
Denmark
Facility Name
Århus Universitetshospital, Skejby
City
Århus
Country
Denmark
Facility Name
HYKS/kirurgian klin./urologia
City
Helsinki
Country
Finland
Facility Name
KYS/kirurgian klin (Kuopio)
City
Kuopio
Country
Finland
Facility Name
OYS/kirurgian klinik
City
Oulu
Country
Finland
Facility Name
TAYS/kirurgian klinik
City
Tampere
Country
Finland
Facility Name
Azienda Ospedaliero Universitaria Ospedali riuniti
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliera S. Giuseppe Moscaaati
City
Avellino
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
City
Bologna
Country
Italy
Facility Name
U.O. Di Urologia - Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Clinica Urologica 1 Universita. Firensa
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
Country
Italy
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
City
Palermo
Country
Italy
Facility Name
Clinica Urologica - Azienda Ospedaliera di Perugia
City
Perugia
Country
Italy
Facility Name
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
City
Roma
Country
Italy
Facility Name
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
City
Torino
Country
Italy
Facility Name
Moelv spesialistsenter
City
Moelv
Country
Norway
Facility Name
Aker Universitetssykehus HF
City
Oslo
Country
Norway
Facility Name
Det Norske Radiumhospitalet HF
City
Oslo
Country
Norway
Facility Name
St Olavs Hospital HF
City
Trondheim
Country
Norway
Facility Name
Hospital Fernando da Fonseca
City
Amadora
Country
Portugal
Facility Name
Hospitais Universidade Coimbra
City
Coimbra
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Hospital S.João
City
Porto
Country
Portugal
Facility Name
Investigational site
City
Göteborg
Country
Sweden
Facility Name
SU/Sahlgrenska
City
Göteborg
Country
Sweden
Facility Name
Helsingborgs Lasarett
City
Helsingborg
Country
Sweden
Facility Name
Universitetssjukhuset MAS
City
Malmö
Country
Sweden
Facility Name
Södertälje Sjukhus
City
Södertälje
Country
Sweden
Facility Name
Uppsala/Akademiska sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Cerrahpasa Faculty of Medicine, Kocamustafapasa
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Faculty of Medicine, ÇAPA
City
Istanbul
Country
Turkey
Facility Name
Marmara University Faculty of Medicine, Altunizade
City
Istanbul
Country
Turkey
Facility Name
Ankara University Faculty of Medicine
City
Sıhhıye - Ankara
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine
City
Sıhhıye - Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22500884
Citation
Axcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tanko LB, Colli E, Klarskov P. Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide. BJU Int. 2012 Dec;110(11):1721-8. doi: 10.1111/j.1464-410X.2012.11107.x. Epub 2012 Apr 13.
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

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Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

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