Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
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 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.
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: 182.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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