Casodex - Nolvadex Combination

Condition(s) targeted: Gynaecomastia; Prostate Cancer

Intervention: Casodex (Drug); Tamoxifen (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Yves Fradet, M.D., Principal Investigator, Affiliation: Quebec City

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.

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

Secondary outcome:

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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

Starting date: November 2002
Ending date: August 2005
Last updated: June 11, 2008