MedTrace Logo

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

NCT00388804 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-08-08

Study results available
· View outcomes & findings →

Summary

Primary Objective:

* To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients traditionally considered at intermediate risk for PSA failure following conventional local therapy. PSA failure will be the primary endpoint.

Secondary Objectives:

* To assess local control, freedom from distant metastasis, and overall survival.
* To study the impact of radiation therapy and/or hormone therapy on health-related quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form 12-American Urological Association Symptom Index (EPIC-SF12-AUASI: http://roadrunner.cancer.med.umich.edu/epic/).
* To assess prognostic value of pretreatment serum testosterone as well as the decrease in hemoglobin from neoadjuvant hormone therapy.
* To assess prognostic value of pretreatment biomarkers on subsequent post-treatment clinical outcomes.

Conditions

Interventions

PROCEDURE

Radiation Therapy

Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.

DRUG

Bicalutamide

50 mg By Mouth (PO) Daily

DRUG

Leuprolide

22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month

DRUG

Goserelin

10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month

DRUG

Flutamide

250 mg by mouth three times daily on first 21-30 Days. May be used instead of Bicalutamide.

BEHAVIORAL

Questionnaire

Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Andrew K. Lee, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

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 NCT00388804 on ClinicalTrials.gov