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Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

NCT00005044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1579

Last updated 2022-06-15

Study results available
· View outcomes & findings →

Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Conditions

Interventions

DRUG

Casodex

Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.

DRUG

Eulexin

Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.

DRUG

LHRH agonist

LHRH agonist of choice. The manufacturer's instructions should be followed.

RADIATION

radiation therapy

\[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)\] OR \[regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin\]

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Michael G. Haddock, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2012-09-30
Completion
2022-05-20

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00005044 on ClinicalTrials.gov