Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
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.
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