Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer

NCT00031889 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-05-15

No results posted yet for this study

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.

Conditions

Interventions

DRUG

Exemestane

Exemestane

DRUG

Exemestane+bicalutamide

Exemestane as in arm I and oral bicalutamide once daily

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Marco Bonomo, MD · Ospedale Beata Vergine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00031889 on ClinicalTrials.gov