Casodex - Nolvadex Combination

AstraZeneca

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Gynaecomastia Prostate Cancer

Interventions

CasodexDRUG

150mg once daily

TamoxifenDRUG

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Outcomes

Secondary Outcomes

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

Data from ClinicalTrials.gov

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