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Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

NCT00651326 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-08-04

No results posted yet for this study

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer.

CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.

Conditions

Interventions

DRUG

bicalutamide

DRUG

buserelin

DRUG

flutamide

DRUG

goserelin

DRUG

leuprolide acetate

PROCEDURE

neoadjuvant therapy

PROCEDURE

quality-of-life assessment

RADIATION

radiation therapy

46 Gy in 23 fractions over \< 5 weeks. Boost: 24-28 Gy in 12-14 fractions over \< 3 weeks

DRUG

Docetaxel

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Michael R. McKenzie, MD, FRCPC · British Columbia Cancer Agency

  • Kim N. Chi, MD · British Columbia Cancer Agency

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-02
Primary Completion
2010-05-14
Completion
2011-01-18

Countries

  • Canada

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 NCT00651326 on ClinicalTrials.gov