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