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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00884273
• Date of registration: 17/04/2009
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
• Scientific title: 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
• Date of first enrolment: August 2009
• Target sample size: 182
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00884273
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Belgium, Denmark, Finland, Italy, Norway, Portugal, Sweden, Turkey

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Bicalutamide

Drug: Degarelix

Drug: Goserelin

Primary Outcome(s)

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) [Time Frame: After treatment of 12 weeks compared to Baseline]

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) [Time Frame: After treatment of 12 weeks compared to Baseline]

Secondary Outcome(s)

Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) [Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline]

Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 [Time Frame: After treatment of 4 and 8 weeks compared to Baseline]

Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit [Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline]

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 [Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline]

Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study [Time Frame: At 4, 8, and 12 weeks compared to baseline.]

Change in Serum Testosterone Levels During the Study [Time Frame: At 4, 8, and 12 weeks compared to baseline.]

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [Time Frame: Baseline to 12 weeks of treatment]

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [Time Frame: Baseline to 12 weeks of treatment]

Secondary ID(s)

2008-008604-40

FE200486 CS31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors