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NCT05946213Recruiting

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

Official recordSimplified version

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.

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

Exclusion criteria

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, United States, Canada, Hong Kong, Singapore
Sponsor
NRG Oncology(Other)
Protocol no.
NRG-GU013
Conditions
Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Interventions
Procedure, Radiation, Other

Treatments studied

  • Biospecimen Collection
  • Bone Scan
  • Computed Tomography
  • External Beam Radiation Therapy
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Stereotactic Body Radiation Therapy

Locations · 431

  • Aarau, SwitzerlandKantonsspital AarauRecruiting at this site
  • Birmingham, United StatesUniversity of Alabama at Birmingham Cancer CenterRecruiting at this site
  • Birmingham, United StatesThe Kirklin Clinic at Acton RoadRecruiting at this site
  • Tuscaloosa, United StatesLewis and Faye Manderson Cancer CenterRecruiting at this site
  • Little Rock, United StatesUniversity of Arkansas for Medical SciencesRecruiting at this site
  • Antioch, United StatesKaiser Permanente-Deer Valley Medical CenterRecruiting at this site
  • Beverly Hills, United StatesTower Cancer Research FoundationRecruiting at this site
  • Dublin, United StatesKaiser Permanente DublinRecruiting at this site
  • Fremont, United StatesKaiser Permanente-FremontRecruiting at this site
  • Fremont, United StatesWashington HealthRecruiting at this site
  • Fresno, United StatesFresno Cancer CenterRecruiting at this site
  • Fresno, United StatesKaiser Permanente Fresno Orchard PlazaRecruiting at this site
  • Fresno, United StatesKaiser Permanente-FresnoRecruiting at this site
  • Irvine, United StatesUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareRecruiting at this site
  • Los Angeles, United StatesThe Angeles Clinic and Research Institute - West Los Angeles OfficeRecruiting at this site
  • Los Angeles, United StatesCedars-Sinai Medical CenterRecruiting at this site
  • Modesto, United StatesKaiser Permanente- Modesto MOB IIRecruiting at this site
  • Modesto, United StatesKaiser Permanente-ModestoRecruiting at this site
  • Oakland, United StatesKaiser Permanente Oakland-BroadwayRecruiting at this site
  • Oakland, United StatesKaiser Permanente-OaklandRecruiting at this site
  • Orange, United StatesUC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting at this site
  • Rancho Cordova, United StatesKaiser Permanente-Rancho Cordova Cancer CenterRecruiting at this site
  • Redwood City, United StatesKaiser Permanente- Marshall Medical OfficesRecruiting at this site
  • Richmond, United StatesKaiser Permanente-RichmondRecruiting at this site
  • Rohnert Park, United StatesRohnert Park Cancer CenterRecruiting at this site
  • Roseville, United StatesKaiser Permanente-RosevilleRecruiting at this site
  • Roseville, United StatesThe Permanente Medical Group-Roseville Radiation OncologyRecruiting at this site
  • Sacramento, United StatesKaiser Permanente Downtown CommonsRecruiting at this site
  • Sacramento, United StatesKaiser Permanente-South SacramentoRecruiting at this site
  • Sacramento, United StatesSouth Sacramento Cancer CenterRecruiting at this site

In total, worldwide, 431 of the 436 sites listed in the registry are recruiting; the other 5 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 401 more locations

Other identifiers

  • NCI-2023-04142 · other registry
  • NRG-GU013 · other identifier
  • NRG-GU013 · other identifier
  • U10CA180868 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.