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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Androgen Antagonists; Androgens; Bicalutamide; Goserelin

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