Back to resultsCMAB vs IMAB in Metastatic Prostate Cancer
Primary Purpose
Metastatic Prostate Cancer
Status
Withdrawn
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Goserelin
Bicalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer
Eligibility 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
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Time to progression
Secondary Outcome Measures
Safety
Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255268
Brief Title
CMAB vs IMAB in Metastatic Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Withdrawn
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Primary Outcome Measure Information:
Title
Time to progression
Secondary Outcome Measure Information:
Title
Safety
Title
Quality of Life
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Mexico Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Metepec
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
CMAB vs IMAB in Metastatic Prostate Cancer
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