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| Sponsor: | Ferring Pharmaceuticals |
|---|---|
| Information provided by: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00833248 |
Purpose
The purpose of this trial is to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who are scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, hormone therapy will be given for three months and patients will be randomly selected (like flipping a coin) to receive either Degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide) The prostate size will be measured by ultra sound at the beginning and at the end of the trial and patients will be required to come to the clinic for 5 or 6 visits during the three months.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Degarelix Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | 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) |
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental | Drug: Degarelix |
| 2: Active Comparator | Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Clinical Development Support | DK0-Disclosure@ferring.com |
Show 45 Study Locations| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
| Responsible Party: | Ferring Pharmaceuticals ( Clinical Development Support ) |
| Study ID Numbers: | FE200486 CS30, 2008-005232-33 (EudraCT No) |
| Study First Received: | January 30, 2009 |
| Last Updated: | December 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00833248 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Greece: National Organization of Medicines; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Goserelin Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Hormones Pharmacologic Actions Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Bicalutamide Prostatic Neoplasms Androgens |