Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Goserelin; Bicalutamide
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.; 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.; 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.
Intervention MeSH terms: Goserelin; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.