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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00233610

Collaborator

(none)

180

Enrollment

Locations

Duration (Months)

16.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Bicalutamide Drug: Tamoxifen	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit. []

Secondary Outcome Measures

Sexual functioning, Quality of life. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Bari	BA	Italy
2	Research Site	Bologna	BO	Italy
3	Research Site	Catania	CT	Italy
4	Research Site	Bagno a Ripoli	FI	Italy
5	Research Site	Firenze	FI	Italy
6	Research Site	Genova	GE	Italy
7	Research Site	Pisa	PI	Italy
8	Research Site	Parma	PR	Italy
9	Research Site	Udine	UD	Italy
10	Research Site	Como		Italy
11	Research Site	Roma		Italy