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NCT05946213

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

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2036-03-31

Brief Summary

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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.

Detailed Description

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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 in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 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.

Patients are followed up every 6 months for 5 years.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (SBRT)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and urine sample collection

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type PROCEDURE

Undergo CT or PET/CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SBRT

Arm II (EBRT)

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and urine sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT or PET/CT

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo EBRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo blood and urine sample collection

Intervention Type PROCEDURE

Bone Scan

Undergo bone scan

Intervention Type PROCEDURE

Computed Tomography

Undergo CT or PET/CT

Intervention Type PROCEDURE

External Beam Radiation Therapy

Undergo EBRT

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type RADIATION

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Bone Scintigraphy 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 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 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 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Quality of Life Assessment SABR SBRT Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

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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) 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)
* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen E Hoffman

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

The Kirklin Clinic at Acton Road

Birmingham, Alabama, United States

Site Status RECRUITING

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status RECRUITING

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status RECRUITING

Kaiser Permanente Dublin

Dublin, California, United States

Site Status RECRUITING

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status RECRUITING

Fresno Cancer Center

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status RECRUITING

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status RECRUITING

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status RECRUITING

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Site Status RECRUITING

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status RECRUITING

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status RECRUITING

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status RECRUITING

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status RECRUITING

South Sacramento Cancer Center

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status RECRUITING

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status RECRUITING

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status RECRUITING

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status RECRUITING

George Washington University Medical Center

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

Site Status RECRUITING

Jupiter Medical Center

Jupiter, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status RECRUITING

Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Proton Therapy Center

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status RECRUITING