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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)


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 ResearchAventura, Florida  33180
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
Urology Centers Of AlabamaHomewood,, Alabama  35205
Urology AssociatesNashville, Tennessee  37209
Urology Group of New MexicoAlbuquerque, New Mexico  87109
Arizona Urologic SpecialistsTucson, Arizona  85712
University Urology AssociatesNew York, New York  10016
Urology of VirginiaNewport News, Virginia  23606
Alabama Research CenterBirmingham, Alabama  35209
Alaska Urological AssociationAnchorage, Alaska  99508
Orange County UrologyLagua Hills, California  92653
Tri-Valley Urology Medical GroupMurrieta, California  92563
DCT -Celebration, LLC dba Discovery Clinical TrialsCelebration, Florida  34747
Pinellas Urology Inc.St. Petersburg, Florida  33710
Palm Beach Urology AssociatesWellington, Florida  33449
Summit Research InstituteBloomington, Indiana  47403
Urology Center Research InstituteEnglewood, New Jersey  07631
Premier Medical Group of HudsonColumbia, New York  12601