A randomised, parallel arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of prostate size reduction in prostate cancer patients of intermediate-to-high risk, who require neoadjuvant hormone therapy prior to radiotherapy (curative intent) - FE200486 CS30

Phase 1

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

• Registration Number: EUCTR2008-005232-33-DE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-25
• Study Completion: 2011-09-26
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

1. Patient has given written informed consent before any trial-related activity is performed.
2. Has a confirmed prostate cancer in which this type of treatment is needed.
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. Previous treatment for prostate cancer
2. Previous trans-urethral resection of the prostate
3. Patients who are lymph node positive or have other metastatic disease
4. Use of urethral catheter
5. Current treatment with a 5-alpha reductase inhibitor or a-adrenoceptor antagonist.
6. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
7. Hypersensitivity towards any component of the investigational product
8. Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
9. Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
10. Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Study & Design

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