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Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00833248
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : September 27, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Drug: Goserelin Drug: Bicalutamide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Study Start Date : April 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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)

On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).

On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

 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 3. The second and third doses of goserelin were administered on Days 31 and 59, 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 14 days after the first dose of goserelin.
Other Name: Casodex


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    TRUS is a method of measuring the size of the prostate.

  2. 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 ]
    TRUS is a method of measuring the size of the prostate.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Change From Baseline in Serum Testosterone Levels During the Study [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  3. Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  4. Change From Baseline in Serum Oestradiol Levels During the Study [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  5. 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 ]
    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').

  6. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline to 12 weeks of treatment ]
    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.

  7. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Baseline to 12 weeks of treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has given written informed consent before any trial-related activity is performed.
  • Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

  • Previous treatment for prostate cancer
  • Previous trans-urethral resection of the prostate
  • Patients who are lymph node positive or have other metastatic disease
  • Use of urethral catheter
  • Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
  • History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Hypersensitivity towards any component of the investigational product
  • Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
  • Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
  • Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833248


Locations
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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00833248    
Other Study ID Numbers: FE200486 CS30
2008-005232-33 ( EudraCT Number )
First Posted: February 2, 2009    Key Record Dates
Results First Posted: September 27, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Goserelin
 Bicalutamide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs