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)
18 Years
N/A
Male
Prostate Cancer
Trial Information
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)
Inclusion Criteria:
- Patient has given written informed consent before any trial-related activity is
performed.
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria:
- 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
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate
cancer and some types of skin cancer.
- 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)
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Outcome Description:
TRUS is a method of measuring the size of the prostate.
Outcome Time Frame:
After treatment of 12 weeks compared to Baseline
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
FE200486 CS30
NCT ID:
NCT00833248
Start Date:
April 2009
Completion Date:
September 2011
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| South Florida Medical Research | Aventura, Florida 33180 |
| Connecticut Clinical Research Center | Waterbury, Connecticut 06708-2652 |
| Northeast Indiana Research | Fort Wayne, Indiana 46804-4128 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Urology Associates | Nashville, Tennessee 37209 |
| Urology Group of New Mexico | Albuquerque, New Mexico 87109 |
| Arizona Urologic Specialists | Tucson, Arizona 85712 |
| University Urology Associates | New York, New York 10016 |
| Urology of Virginia | Newport News, Virginia 23606 |
| Alabama Research Center | Birmingham, Alabama 35209 |
| Alaska Urological Association | Anchorage, Alaska 99508 |
| Orange County Urology | Lagua Hills, California 92653 |
| Tri-Valley Urology Medical Group | Murrieta, California 92563 |
| DCT -Celebration, LLC dba Discovery Clinical Trials | Celebration, Florida 34747 |
| Pinellas Urology Inc. | St. Petersburg, Florida 33710 |
| Palm Beach Urology Associates | Wellington, Florida 33449 |
| Summit Research Institute | Bloomington, Indiana 47403 |
| Urology Center Research Institute | Englewood, New Jersey 07631 |
| Premier Medical Group of Hudson | Columbia, New York 12601 |
