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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
Endpoint Classification: Safety/Efficacy Study
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:

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

Genders 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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
Great Britain: Medicines and Healthcare Product Regulatory Agency
Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:
Casodex
bicalutamide
Tamoxifen
Gynaecomastia
Prostate Cancer

Additional relevant MeSH terms:
Gynecomastia
Prostatic Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Tamoxifen
Bicalutamide
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Androgen Antagonists

ClinicalTrials.gov processed this record on May 19, 2013