Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233610
• Other study ID #: 7054IT/0003
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: January 25, 2011
• Start date: December 2003
• Est. completion date: October 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed prostate cancer

• Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

Exclusion Criteria:

• Age > 75 yrs

• No metastatic disease (M1).

• No presence of gynaecomastia and/or mastalgia at screening

• No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gynecomastia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide

• Tamoxifen

Locations

Country	Name	City	State
Italy	Research Site	Bagno a Ripoli	FI
Italy	Research Site	Bari	BA
Italy	Research Site	Bologna	BO
Italy	Research Site	Catania	CT
Italy	Research Site	Como
Italy	Research Site	Firenze	FI
Italy	Research Site	Genova	GE
Italy	Research Site	Parma	PR
Italy	Research Site	Pisa	PI
Italy	Research Site	Roma
Italy	Research Site	Udine	UD

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary	Sexual functioning, Quality of life.