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Testing Shorter Radiation for High-Risk Prostate Cancer

This study is comparing two types of radiation therapy for men with high-risk prostate cancer: stereotactic body radiation therapy (SBRT), which involves 5 treatments over 2 weeks, and the usual radiation therapy, which takes 20 to 45 treatments over 4 to 9 weeks. The goal is to see if the shorter SBRT treatment is just as effective at preventing the cancer from spreading (metastasis-free survival) as the longer, usual radiation. You may be eligible if you are an adult male with a confirmed diagnosis of high-risk prostate adenocarcinoma. The study is currently unclear on its recruitment status and plans to enroll 1209 participants.

Study design
This is an interventional study comparing two different radiation therapy schedules. It plans to enroll 1209 adult male participants.
What's involved
You would undergo blood and urine sample collection, a bone scan, CT or PET/CT, MRI, and receive either SBRT or usual external beam radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for metastasis-free survival for up to 15 years after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05946213

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
NRG Oncology
~1,209 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanComputed TomographyExternal Beam Radiation TherapyMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
409 of 413 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Metastasis-free survival (MFS)
Measured over From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

413 sites across 47 states
Illinois42
Wisconsin39
California37
Ohio30
Pennsylvania27
Michigan24
New York22
Minnesota19

Study leadership

  • Karen E Hoffman · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Metastasis-free survival (MFS)From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

    Based on conventional imaging. Median MFS time comparing the curves.