CMAB vs IMAB in Metastatic Prostate Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255268

Purpose

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.

Condition	Intervention	Phase
Metastatic Prostate Cancer	Drug: Goserelin Drug: Bicalutamide	Phase IV

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to progression

Secondary Outcome Measures:

Safety
Quality of Life

Estimated Enrollment:	15
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological diagnosis of D2 of Adenocarcinoma,
Naivety to treatment
Valuable bone metastasis

Exclusion Criteria:

Hematological, liver or renal toxicity Grade IV
Severe and active infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255268

Locations

Mexico
Research Site
Mexico City, Mexico
Research Site
Metepec, Mexico

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Mexico Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D6876L00010
Study First Received:	October 26, 2005
Last Updated:	August 24, 2007
ClinicalTrials.gov Identifier:	NCT00255268
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Goserelin
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents

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

ClinicalTrials.gov processed this record on January 16, 2009