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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00590213 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Casodex 150mg Procedure: Radiotherapy Procedure: Haematology |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 Prostate Cancer Patients |
Estimated Enrollment: | 125 |
Study Start Date: | June 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Research Site | |
Adana, Turkey | |
Research Site | |
Ankara, Turkey | |
Research Site | |
Diyarbak?r, Turkey | |
Research Site | |
Edirne, Turkey | |
Research Site | |
Samsun, Turkey | |
Research Site | |
Istanbul, Turkey | |
Research Site | |
Izmir, Turkey | |
Research Site | |
Manisa, Turkey | |
Research Site | |
Eskisehir, Turkey |
Principal Investigator: | Haluk Ozen, Prof | Hacettepe Univ. Med. Fac |
Responsible Party: | Turkey Clinical Study Information ( AstraZeneca ) |
Study ID Numbers: | 7054TR/01 |
Study First Received: | December 28, 2007 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00590213 |
Health Authority: | Turkey: Ministry of Health |
Casodex Prostate Cancer |
Prostatic Diseases Genital Neoplasms, Male Bicalutamide Urogenital Neoplasms |
Pain Genital Diseases, Male Prostatic Neoplasms Gynecomastia |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |