Casodex - Nolvadex Combination

NCT00637871 — Phase 2, Completed, AstraZeneca

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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…..

Registry	NCT00637871
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	AstraZeneca (Industry)
Conditions	Gynaecomastia, Prostate Cancer
Interventions	Casodex, Tamoxifen (Drug)
Dates	start 2002-11-01, primary completion 2005-06-01, completion 2005-08-01, first posted 2008-03-18, last updated 2011-01-24

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: Casodex
2	Active comparator	Drug: Tamoxifen

Casodex (Drug): 150mg once daily
Tamoxifen (Drug), also known as Nolvadex

+Outcome measures

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

+Eligibility

Sex: Male

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

+Investigators

Yves Fradet, M.D., Principal investigator, Quebec City