Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer | Stopped
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Health Conditions
  • Prostate Cancer
Stopped
Recruitment Status
NCT00831233
Primary Trial ID Number
Summary
The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
Primary Outcome Measures
  • Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12; After treatment of 12 weeks compared to Baseline
Secondary Outcome Measures
  • Change From Baseline in Total IPSS at Weeks 4 and 8; After treatment of 4 and 8 weeks compared to Baseline; Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Residual Volume (Vresidual) at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12; After 12 weeks treatment compared to Baseline; Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight; Baseline to 12 weeks of treatment; Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables; Baseline to 12 weeks of treatment
Research Question
  • The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Germany; Spain; United Kingdom
Participant Sex
Male
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
  • - Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
  • - Patients in need of external beam radiotherapy to be started at the same time as
  • hormone therapy
  • - 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)
  • - 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.
  • - 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.
Participant Exclusion 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
  • - Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
  • - Patients in need of external beam radiotherapy to be started at the same time as
  • hormone therapy
  • - 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)
  • - 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.
  • - 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.
Interventions
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.; [Degarelix 240 mg/80 mg]; Drug; Goserelin; Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.; [Goserelin (3.6 mg) + bicalutamide (50 mg)]; Drug; Bicalutamide; On Day 0, three days before the first dose of goserelin on Day 3, patients 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.; [Goserelin (3.6 mg) + bicalutamide (50 mg)]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer
Secondary Trial Identifying Number
2008-004338-26
Website
Sorry, this information is not available
Study Funded By
Ferring Pharmaceuticals
Funder Type
Sorry, this information is not available
Study Sponsored By
Ferring Pharmaceuticals
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

27 Jan 2009

Last Updated

18 Oct 2013

Date Record Refreshed on UKCTG

01 Aug 2015