Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Criteria

Inclusion 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (SBRT)
Patients undergo SBRT for a total of 5 treatments over 2 weeks.
  • Radiation: Stereotactic Body Radiation Therapy
    Undergo SBRT
    Other names:
    • SABR
    • SBRT
    • Stereotactic Ablative Body Radiation Therapy
Active Comparator
Arm II (EBRT)
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks.
  • Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other names:
    • Definitive Radiation Therapy
    • EBRT
    • External Beam Radiation
    • External Beam Radiotherapy
    • External Beam Radiotherapy (conventional)
    • External Beam RT
    • external radiation
    • External Radiation Therapy
    • external-beam radiation
    • Radiation, External Beam
    • Teleradiotherapy
    • Teletherapy
    • Teletherapy Radiation

Recruiting Locations

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Dublin
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691

Kaiser Permanente-Fremont
Fremont, California 94538
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Fresno Cancer Center
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Modesto
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691

Kaiser Permanente-Richmond
Richmond, California 94801
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Rohnert Park Cancer Center
Rohnert Park, California 94928
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Kaiser Permanente-South Sacramento
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

South Sacramento Cancer Center
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente San Leandro
San Leandro, California 94577
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Jupiter Medical Center
Jupiter, Florida 33458
Contact:
Site Public Contact
561-745-5768

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

McFarland Clinic - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Luke's Hospital of Duluth
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-249-7825
kdean@slhduluth.com

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Westchester Medical Center
Valhalla, New York 10595
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Aultman Health Foundation
Canton, Ohio 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Reading Hospital
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718

More Details

NCT ID
NCT05946213
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVE: I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. SECONDARY OBJECTIVES: I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms. II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains). III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain). IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms. V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms. VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms. VIII. To compare overall survival between treatment arms. EXPLORATORY OBJECTIVES: I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms. II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks. ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks. Patients are followed up every 6 months for 5 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.