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Casodex - Nolvadex Combination

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 12, 2008
Last updated: January 21, 2011
Last verified: January 2011
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:

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


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

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 identifier: NCT00637871

Sponsors and Collaborators
Principal Investigator: Yves Fradet, M.D. Quebec City
  More Information Identifier: NCT00637871     History of Changes
Other Study ID Numbers: 7054IL/0044
Study First Received: March 12, 2008
Last Updated: January 21, 2011

Keywords provided by AstraZeneca:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
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 processed this record on June 22, 2017