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Completed

NCT Number: NCT00637871

Casodex - Nolvadex Combination

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.

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Key information

Conditions

Gynaecomastia Breast Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gynecomastia Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Casodex

Drug

150mg once daily

Tamoxifen

Drug

Other names: Nolvadex

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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…..

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Mar 18, 2008
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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