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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00233610

First received: October 4, 2005

Last updated: January 25, 2011

Last verified: January 2011

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Bicalutamide

U.S. FDA Resources

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
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Astra Zeneca	AstraZeneca

More Information


ClinicalTrials.gov Identifier:	NCT00233610 History of Changes
Other Study ID Numbers:	7054IT/0003
Study First Received:	October 4, 2005
Last Updated:	January 25, 2011

Keywords provided by AstraZeneca:


Casodex monotherapy

Additional relevant MeSH terms:


Gynecomastia Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Breast Diseases Skin Diseases Tamoxifen	Bicalutamide Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Androgen Antagonists

ClinicalTrials.gov processed this record on July 14, 2017

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