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Clinical Trials in Canada / NCT05946213
Recruiting Phase 3

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

NCT05946213 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2023-12-14
Last updated
2026-09-10

Condition(s) studied

Prostate AdenocarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionBone ScanComputed TomographyExternal Beam Radiation TherapyMagnetic Resonance ImagingPositron Emission TomographyQuality-of-Life AssessmentQuestionnaire AdministrationStereotactic Body Radiation Therapy

Biospecimen Collection: Undergo blood and urine sample collection

Bone Scan: Undergo bone scan

Computed Tomography: Undergo CT or PET/CT

External Beam Radiation Therapy: Undergo EBRT

Magnetic Resonance Imaging: Undergo MRI

Positron Emission Tomography: Undergo PET/CT

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Stereotactic Body Radiation Therapy: Undergo SBRT

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (413)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
The Kirklin Clinic at Acton Road Birmingham Alabama Recruiting
Lewis and Faye Manderson Cancer Center Tuscaloosa Alabama Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Tower Cancer Research Foundation Beverly Hills California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Washington Hospital Fremont California Recruiting
Fresno Cancer Center Fresno California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Kaiser Permanente- Modesto MOB II Modesto California Recruiting
Kaiser Permanente-Modesto Modesto California Recruiting
Kaiser Permanente Oakland-Broadway Oakland California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California Recruiting
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California Recruiting
Kaiser Permanente- Marshall Medical Offices Redwood City California Recruiting
Kaiser Permanente-Richmond Richmond California Recruiting
Rohnert Park Cancer Center Rohnert Park California Recruiting
Kaiser Permanente-Roseville Roseville California Recruiting
The Permanente Medical Group-Roseville Radiation Oncology Roseville California Recruiting
Kaiser Permanente Downtown Commons Sacramento California Recruiting
Kaiser Permanente-South Sacramento Sacramento California Recruiting
South Sacramento Cancer Center Sacramento California Recruiting
Kaiser Permanente-San Francisco San Francisco California Recruiting
Kaiser Permanente-Santa Teresa-San Jose San Jose California Recruiting
Kaiser Permanente San Leandro San Leandro California Recruiting
Kaiser San Rafael-Gallinas San Rafael California Recruiting
Kaiser Permanente Medical Center - Santa Clara Santa Clara California Recruiting
Kaiser Permanente-Santa Rosa Santa Rosa California Recruiting
Kaiser Permanente Cancer Treatment Center South San Francisco California Recruiting
Kaiser Permanente-South San Francisco South San Francisco California Recruiting
Kaiser Permanente-Stockton Stockton California Recruiting
Torrance Memorial Physician Network - Cancer Care Torrance California Recruiting
Kaiser Permanente Medical Center-Vacaville Vacaville California Recruiting
Kaiser Permanente-Vallejo Vallejo California Recruiting

+ 373 more sites — see the full list on the official registry below.

More NRG Oncology trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05946213 on ClinicalTrials.gov ↗ ← All trials in Canada