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CMAB vs IMAB in Metastatic Prostate Cancer

NCT ID: NCT00255268

Last Updated: 2007-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Goserelin

Intervention Type DRUG

Bicalutamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Mexico Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Metepec, , Mexico

Site Status

Research Site

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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D6876L00010

Identifier Type: -

Identifier Source: org_study_id