Casodex - Nolvadex Combination

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00637871

First received: March 12, 2008

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Gynaecomastia Prostate Cancer	Drug: Casodex Drug: Tamoxifen	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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…..

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Bicalutamide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Secondary Outcome Measures:

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


Study Start Date:	November 2002
Study Completion Date:	August 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Casodex 150mg once daily
Active Comparator: 2	Drug: Tamoxifen Other Name: Nolvadex

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637871

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Yves Fradet, M.D.	Quebec City

More Information


ClinicalTrials.gov Identifier:	NCT00637871 History of Changes
Other Study ID Numbers:	7054IL/0044 D6876C00044
Study First Received:	March 12, 2008
Last Updated:	January 21, 2011

Keywords provided by AstraZeneca:


Casodex bicalutamide Tamoxifen Gynaecomastia Prostate Cancer

Additional relevant MeSH terms:


Gynecomastia Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Breast Diseases Skin Diseases Tamoxifen	Bicalutamide Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Androgen Antagonists

ClinicalTrials.gov processed this record on July 14, 2017

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