Back to resultsTwo Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Bicalutamide
Tamoxifen
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring Casodex monotherapy
Eligibility Criteria
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary Outcome Measures
Sexual functioning, Quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233610
Brief Title
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Casodex monotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Primary Outcome Measure Information:
Title
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary Outcome Measure Information:
Title
Sexual functioning, Quality of life.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astra Zeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Bari
State/Province
BA
Country
Italy
Facility Name
Research Site
City
Bologna
State/Province
BO
Country
Italy
Facility Name
Research Site
City
Catania
State/Province
CT
Country
Italy
Facility Name
Research Site
City
Bagno a Ripoli
State/Province
FI
Country
Italy
Facility Name
Research Site
City
Firenze
State/Province
FI
Country
Italy
Facility Name
Research Site
City
Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Pisa
State/Province
PI
Country
Italy
Facility Name
Research Site
City
Parma
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Udine
State/Province
UD
Country
Italy
Facility Name
Research Site
City
Como
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
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