A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
Inclusion Criteria:
- Histologically confirmed prostate cancer
- Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy
Exclusion Criteria:
- Age > 75 yrs
- No metastatic disease (M1).
- No presence of gynaecomastia and/or mastalgia at screening
- No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6
months of trial entry.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Principal Investigator
Astra Zeneca
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Italy: Ministry of Health
Study ID:
7054IT/0003
NCT ID:
NCT00233610
Start Date:
December 2003
Completion Date:
October 2007
Related Keywords:
- Prostate Cancer
- Casodex monotherapy
- Gynecomastia
- Prostatic Neoplasms
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