Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,209

participants targeted

Target at P75+ for phase_3

Timeline

121mo left

Started Dec 2023

Longer than P75 for phase_3

Geographic Reach

4 countries

383 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.3 years study duration

Study Progress20%

Dec 2023Mar 2036

First Submitted

Initial submission to the registry

June 28, 2023

Completed

16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed

5 months until next milestone

Study Start

First participant enrolled

December 14, 2023

Completed

12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2036

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2036

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

12.3 years

First QC Date

June 28, 2023

Last Update Submit

January 29, 2026

Conditions

Prostate Adenocarcinoma Stage IVA Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Metastasis-free survival (MFS)
Based on conventional imaging. Median MFS time comparing the curves.
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

Secondary Outcomes (8)

Failure-free survival
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Overall survival
From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years
MFS
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Incidence of adverse events (AEs)
Up to 15 years
Urinary incontinence
Up to 5 years
+3 more secondary outcomes

Other Outcomes (5)

Patient-reported outcomes
Up to 5 years
Cost
Up to 1 year
Estimate of treatment effect by sex
Up to 15 years
+2 more other outcomes

Study Arms (2)

Arm I (SBRT)

EXPERIMENTAL

Patients undergo SBRT for a total of 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

Procedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Stereotactic Body Radiation Therapy

Arm II (EBRT)

ACTIVE COMPARATOR

Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

Procedure: Biospecimen CollectionProcedure: Computed TomographyRadiation: External Beam Radiation TherapyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (SBRT)Arm II (EBRT)

Bone ScanPROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Arm I (SBRT)

Computed TomographyPROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm I (SBRT)Arm II (EBRT)

External Beam Radiation TherapyRADIATION

Undergo EBRT

Also known as: 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

Arm II (EBRT)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (SBRT)Arm II (EBRT)

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm I (SBRT)Arm II (EBRT)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SBRT)Arm II (EBRT)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (SBRT)Arm II (EBRT)

Stereotactic Body Radiation TherapyRADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Arm I (SBRT)

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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) value \> 20 ng/mL prior to starting androgen deprivation therapy (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 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
No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy)
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; Please note: PSA prior to the start of any ADT will be used to define disease
No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologylead

Study Sites (383)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States

RECRUITING

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, 35401, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

RECRUITING

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

RECRUITING

Kaiser Permanente Dublin

Dublin, California, 94568, United States

RECRUITING

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

RECRUITING

Washington Hospital

Fremont, California, 94538, United States

RECRUITING

Fresno Cancer Center

Fresno, California, 93720, United States

RECRUITING

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, 93720, United States

RECRUITING

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Kaiser Permanente- Modesto MOB II

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

RECRUITING

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, 94063, United States

RECRUITING

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

RECRUITING

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

RECRUITING

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

RECRUITING

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

RECRUITING

South Sacramento Cancer Center

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

RECRUITING

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

RECRUITING

Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505, United States

RECRUITING

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

RECRUITING

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

RECRUITING

Jupiter Medical Center

Jupiter, Florida, 33458, United States

RECRUITING

Moffitt Cancer Center at SouthShore

Ruskin, Florida, 33570, United States

RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States

RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza