Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

AstraZeneca180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

180

Conditions

Prostate Cancer

Interventions

BicalutamideDRUG

TamoxifenDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (11)

Research Site

Bari, BA, Italy

Research Site

Bologna, BO, Italy

Research Site

Catania, CT, Italy

Research Site

Bagno a Ripoli, FI, Italy

Outcomes

Primary Outcomes

Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.

Secondary Outcomes

Sexual functioning, Quality of life.

Data from ClinicalTrials.gov

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