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 - FE200486 CS31

• Conditions: Prostate cancer; MedDRA version: 9.1Level: PTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2008-008604-40-SE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-03
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 180

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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified