Casodex - Nolvadex Combination

Prostate Cancer Clinical Trial

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…..

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637871
• Other study ID #: 7054IL/0044
• Secondary ID: D6876C00044
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: January 21, 2011
• Start date: November 2002
• Est. completion date: August 2005

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaFinland: Finnish Medicines AgencyGreat Britain: Medicines and Healthcare Product Regulatory AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gynaecomastia
• Gynecomastia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Casodex
150mg once daily
• Tamoxifen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	To describe the extent of gynaecomastia and breast pain by treatment group
Secondary	To describe the relative change from baseline in sex hormones concentrations by treatment group
Secondary	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
Secondary	To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily