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

This study is ongoing, but not recruiting participants.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00233610

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: Bicalutamide Drug: Tamoxifen	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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.

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment:	180
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233610

Locations

Italy
Research Site
Como, Italy
Research Site
Roma, Italy
Italy, BA
Research Site
Bari, BA, Italy
Italy, BO
Research Site
Bologna, BO, Italy
Italy, CT
Research Site
Catania, CT, Italy
Italy, FI
Research Site
Bagno a Ripoli, FI, Italy
Research Site
FIRENZE, FI, Italy
Italy, GE
Research Site
Genova, GE, Italy
Italy, PI
Research Site
Pisa, PI, Italy
Italy, PR
Research Site
Parma, PR, Italy
Italy, UD
Research Site
Udine, UD, Italy

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Astra Zeneca

AstraZeneca

More Information

Study ID Numbers:	7054IT/0003
Study First Received:	October 4, 2005
Last Updated:	June 29, 2006
ClinicalTrials.gov Identifier:	NCT00233610
Health Authority:	Italy: Ministry of Health

Keywords provided by AstraZeneca:

Casodex monotherapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Bicalutamide
Urogenital Neoplasms

Genital Diseases, Male
Tamoxifen
Prostatic Neoplasms
Breast Diseases
Gynecomastia

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009