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Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

NCT00002874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2022-06-15

Study results available
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Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

Conditions

Interventions

DRUG

bicalutamide

One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

RADIATION

radiation therapy

64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.

DRUG

placebo

One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • William U. Shipley, MD · Massachusetts General Hospital and Harvard Medical School, Boston

  • Himanshu R Lukka, MD · Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON

  • Pierre P Major, MD · Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON

  • Niall M Heney, MD · Massachusetts General Hospital and Harvard Medical School, Boston

  • David J Grignon, MD · Indiana University, Indianapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-02-28
Primary Completion
2015-08-31
Completion
2022-05-20

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT00002874 on ClinicalTrials.gov