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…..”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2005

Intervention(s) in this Clinical Trial

• Drug: Casodex
  • 150mg once daily
• Drug: Tamoxifen

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Secondary 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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Yves Fradet, M.D. Principal Investigator Quebec City  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637871

Study ID Number: 7054IL/0044

ClinicalTrials.gov Identifier: NCT00637871

Health Authority: United States: Food and Drug Administration