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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00884273
First received: April 17, 2009
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Goserelin
Drug: Bicalutamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) [ Time Frame: After treatment of 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: After treatment of 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: After treatment of 4 and 8 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 4, 8, and 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
  • Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study [ Time Frame: At 4, 8, and 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
  • Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 182
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 240 mg/80 mg
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.
Drug: Degarelix
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.
Other Names:
  • FE200486
  • FIRMAGON
Active Comparator: Goserelin (3.6 mg) + bicalutamide (50 mg)

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.

Drug: Goserelin
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.
Other Name: ZOLADEX
Drug: Bicalutamide
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.
Other Name: CASODEX

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884273

  Show 46 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications:
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884273     History of Changes
Other Study ID Numbers: FE200486 CS31, 2008-008604-40
Study First Received: April 17, 2009
Results First Received: February 1, 2012
Last Updated: October 21, 2013
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Italy: The Italian Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Turkey: Ministry of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Androgens
Bicalutamide
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014