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Casodex - Nolvadex Combination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637871
First Posted: March 18, 2008
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 12, 2008
First Posted: March 18, 2008
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Casodex
bicalutamide
Tamoxifen
Gynaecomastia
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Gynecomastia
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