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

A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration

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