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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This study has been withdrawn prior to enrollment.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
October 26, 2005
November 18, 2005
August 28, 2007
August 2004
Not Provided
Time to progression
Same as current
Complete list of historical versions of study NCT00255268 on ClinicalTrials.gov Archive Site
  • Safety
  • Quality of Life
Same as current
Not Provided
Not Provided
 
CMAB vs IMAB in Metastatic Prostate Cancer
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Prostate Cancer
  • Drug: Goserelin
  • Drug: Bicalutamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
15
Not Provided
Not Provided

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
Canada,   Finland,   Norway,   United Kingdom
 
NCT00255268
D6876L00010
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Mexico Medical Director, MD AstraZeneca
AstraZeneca
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP