Casodex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gynaecomastia Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

Intervention Type DRUG

150mg once daily

2

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

Interventions

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Casodex

150mg once daily

Intervention Type DRUG

Tamoxifen

Intervention Type DRUG

Other Intervention Names

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Nolvadex

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No