Neoadjuvant 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 first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, 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 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: 246.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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

          -  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.