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

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-04
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patient has given written informed consent before any trial-related activity is performed.
Patient is 18 years or older.
Planned for radical radiotherapy treatment and in whom neoadjuvant endocrine treatment is indicated.
Tumour, Nodule, and Metastatic (TNM) stage T2 (b or c)/T3/T4, N0, M0; or Gleason score = 7 or PSA = 10 ng/ml.
Eastern Co-operative Oncology Group (ECOG) score of ? 2.
Estimated life expectancy at least 30 months.
Prostate size > 30 cubic centimetres, measured by TRUS.
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

Any previous treatment for prostate cancer.
Previous trans-urethral resection of the prostate.
Patients who are lymph node positive or have other metastatic disease.
Use of urethral catheter.
Is not considered a candidate for hormonal therapy as neoadjuvant treatment to radiotherapy.
Is currently treated with a 5-alpha reductase inhibitor. If the patient has been treated with a 5-alpha reductase inhibitor the treatment must have stopped at least 6 months prior to this study.
Is currently treated with an a-adrenoceptor antagonist. If the patient has been treated with an a-adrenoceptor antagonist the treatment must have stopped at least 8 weeks prior to this study.
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Hypersensitivity towards any component of the investigational products.
Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
Has a corrected QT interval (using the Fridericia correction method) over 450 msec.
Has a history of or risk factors for Torsades de Pointes
At time of inclusion receive concomitant medications that might prolong the QT interval
A clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient’s health or the outcome of the trial as judged by the Investigator.
Mental incapacity or language barrier precluding adequate understanding or co-operation.
Receipt of an investigational drug within the last 28 days proceeding screening or longer if considered to possibly influence the outcome of the current trial.
Previous participation in any degarelix trial.

Study & Design

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