Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Description

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Conditions

Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

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Study Overview

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Study Details

Study overview

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Condition
Stage III Prostate Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States, 35233

Tuscaloosa

Lewis and Faye Manderson Cancer Center, Tuscaloosa, Alabama, United States, 35401

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Antioch

Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States, 94531

Beverly Hills

Tower Cancer Research Foundation, Beverly Hills, California, United States, 90211

Dublin

Kaiser Permanente Dublin, Dublin, California, United States, 94568

Fremont

Kaiser Permanente-Fremont, Fremont, California, United States, 94538

Fresno

Fresno Cancer Center, Fresno, California, United States, 93720

Fresno

Kaiser Permanente-Fresno, Fresno, California, United States, 93720

Irvine

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States, 92612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • * High-risk disease defined as having at least one or more of the following:
  • * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
  • * The patient's prostate specific antigen (PSA) \> 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
  • * Gleason Score of 8-10
  • * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
  • * Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
  • * No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
  • * Age \>= 18
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • * No prior radical prostatectomy
  • * Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration
  • * Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Karen E Hoffman, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

2041-03-31