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| Sponsored by: |
AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00590213 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | Turkey: Ministry of Health |
|
Casodex Prostate Cancer |
|
Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Pain Urogenital Neoplasms Genital Diseases, Male |
Hormones Androgen Antagonists Bicalutamide Prostatic Neoplasms Gynecomastia Androgens |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Pharmacologic Actions Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Bicalutamide Prostatic Neoplasms |