Prostate cancer MedDRA version: 9.1 Level: PT Classification code 10060862 Term: Prostate cancer
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean percentage reduction in prostate volume measured with TRUS [ Time Frame: End of trial (12 weeks) compared to baseline. ] [ Designated as safety issue: No ];Secondary Objective: Mean percentage reduction in prostate volume [ Time Frame: At 4 and at 8 weeks compared to baseline. ] Lower urinary tract symptom (LUTS) relief based on international prostate symptom score (IPSS) form [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] Change in testosterone based on serum level measurements [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] Mean percentage change in PSA based on serum level measurements [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] Change in Quality of Life evaluation due to urinary symptoms based on the supplementary question on quality of life on the IPSS form [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] Change in burden of urinary symptoms based on the benign prostatic hyperplasia impact index (BPHII) [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] Frequency and severity of adverse events (AEs) and clinically significant change in laboratory value [ Time Frame: During the entire study ] ;Primary end point(s): Mean percentage reduction in prostate volume measured with TRUS [ Time Frame: End of trial (12 weeks) compared to baseline. ] [ Designated as safety issue: No ] | — |
Countries
Belgium, Denmark, Finland, Italy, Portugal, Sweden
Outcome results
None listed