Back to resultsCasodex - Nolvadex Combination
Primary Purpose
Gynaecomastia, Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Casodex
Tamoxifen
Sponsored by
About this trial
This is an interventional treatment trial for Gynaecomastia focused on measuring Casodex, bicalutamide, Tamoxifen, Gynaecomastia, Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
- Subjects in need of immediate hormonal therapy.
- PSA equal or above 4 ng/ml
Exclusion Criteria:
- Presence of gynaecomastia and/or breast pain at screening visit
- Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
- Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
- Previous mastectomy or radiation to chest wall
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
To describe the extent of gynaecomastia and breast pain by treatment group
To describe the relative change from baseline in sex hormones concentrations by treatment group
To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily
To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637871
Brief Title
Casodex - Nolvadex Combination
Official Title
Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynaecomastia, Prostate Cancer
Keywords
Casodex, bicalutamide, Tamoxifen, Gynaecomastia, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Casodex
Intervention Description
150mg once daily
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Nolvadex
Secondary Outcome Measure Information:
Title
To describe the extent of gynaecomastia and breast pain by treatment group
Title
To describe the relative change from baseline in sex hormones concentrations by treatment group
Title
To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily
Title
To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
Subjects in need of immediate hormonal therapy.
PSA equal or above 4 ng/ml
Exclusion Criteria:
Presence of gynaecomastia and/or breast pain at screening visit
Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
Previous mastectomy or radiation to chest wall
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Fradet, M.D.
Organizational Affiliation
Quebec City
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Casodex - Nolvadex Combination
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