Clinical Trial: Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Randomised Trial to Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX Monotherapy Induced Gynaecomastia and/or Breast Pain in Pro

Brief Summary: The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: To examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To examine the tolerability of radiotherapy to male breast
  • To examine the tolerability of Casodex 150mg in localized and locally advanced prostate cancer patients
  • To examine the efficacy of Casodex 150mg in prostate cancer patients


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: December 28, 2007
Date Started: June 2003
Date Completion:
Last Updated: January 23, 2008
Last Verified: January 2008