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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
OBJECTIVES: Primary * Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary * Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients. * Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost). * Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs \< 2), and radiotherapy (RT) modality (dose-escalated external-beam RT \[EBRT\] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. After completion of study therapy, patients are followed up periodically.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
21st Century Oncology-Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States
Mercy Cancer Center-Hot Springs
Hot Springs, Arkansas, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Start Date
September 1, 2009
Primary Completion Date
October 3, 2020
Completion Date
September 4, 2025
Last Updated
March 6, 2026
1,538
ACTUAL participants
bicalutamide
DRUG
flutamide
DRUG
LHRH agonist (antagonist) therapy
DRUG
Dose-Escalated Radiation Therapy
RADIATION
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494