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Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

NCT00796458 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-08-12

No results posted yet for this study

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.

Conditions

Interventions

DRUG

docetaxel

Given IV

DRUG

releasing hormone agonist therapy

Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.

Sponsors & Collaborators

  • A.O.U. San Giovanni Battista di Torino, Italy

    lead OTHER

Principal Investigators

  • Oscar Bertetto, MD · Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

  • Isabella Chiappino, MD · A.O.U. San Giovanni Battista di Torino, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2013-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT00796458 on ClinicalTrials.gov