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Casodex - Nolvadex Combination

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ClinicalTrials.gov Identifier: NCT00637871
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : January 24, 2011
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Gynaecomastia Prostate Cancer Drug: Casodex Drug: Tamoxifen Phase 2

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Study Type : Interventional  (Clinical Trial)
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…..
Study Start Date : November 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Casodex
150mg once daily

Active Comparator: 2 Drug: Tamoxifen
Other Name: Nolvadex

Secondary Outcome Measures :
  1. To describe the extent of gynaecomastia and breast pain by treatment group
  2. To describe the relative change from baseline in sex hormones concentrations by treatment group
  3. 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
  4. To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
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Principal Investigator: Yves Fradet, M.D. Quebec City
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ClinicalTrials.gov Identifier: NCT00637871    
Other Study ID Numbers: 7054IL/0044
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
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