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CMAB vs IMAB in Metastatic Prostate Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255268
First Posted: November 18, 2005
Last Update Posted: August 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255268


Locations
Mexico
Research Site
Metepec, Mexico
Research Site
Mexico City, Mexico
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Mexico Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00255268     History of Changes
Other Study ID Numbers: D6876L00010
First Submitted: October 26, 2005
First Posted: November 18, 2005
Last Update Posted: August 28, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Bicalutamide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs