Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Recruiting · NCT05946213 · Interventional (participants receive a specific treatment) · Lead sponsor: NRG Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionBone ScanComputed TomographyExternal Beam Radiation TherapyMagnetic Resonance ImagingPositron Emission TomographyQuality-of-Life AssessmentQuestionnaire AdministrationStereotactic Body Radiation Therapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific 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
Where it is running
60 locations listed across 42 US states.
- University of Alabama at Birmingham Cancer Center - Birmingham, Alabama, United States
- The Kirklin Clinic at Acton Road - Birmingham, Alabama, United States
- Lewis and Faye Manderson Cancer Center - Tuscaloosa, Alabama, United States
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
- Tower Cancer Research Foundation - Beverly Hills, California, United States
- Kaiser Permanente Dublin - Dublin, California, United States
- Kaiser Permanente-Fremont - Fremont, California, United States
- Washington Hospital - Fremont, California, United States
- Fresno Cancer Center - Fresno, California, United States
- Kaiser Permanente Fresno Orchard Plaza - Fresno, California, United States
- Kaiser Permanente-Fresno - Fresno, California, United States
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Kaiser Permanente- Modesto MOB II - Modesto, California, United States
- Kaiser Permanente-Modesto - Modesto, California, United States
- Kaiser Permanente Oakland-Broadway - Oakland, California, United States
- Kaiser Permanente-Oakland - Oakland, California, United States
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange, California, United States
- Kaiser Permanente-Rancho Cordova Cancer Center - Rancho Cordova, California, United States
- Kaiser Permanente- Marshall Medical Offices - Redwood City, California, United States
- Kaiser Permanente-Richmond - Richmond, California, United States
- Rohnert Park Cancer Center - Rohnert Park, California, United States
- Kaiser Permanente-Roseville - Roseville, California, United States
- The Permanente Medical Group-Roseville Radiation Oncology - Roseville, California, United States
- Kaiser Permanente Downtown Commons - Sacramento, California, United States
- Kaiser Permanente-South Sacramento - Sacramento, California, United States
- South Sacramento Cancer Center - Sacramento, California, United States
- Kaiser Permanente-San Francisco - San Francisco, California, United States
- Kaiser Permanente-Santa Teresa-San Jose - San Jose, California, United States
- Kaiser Permanente San Leandro - San Leandro, California, United States
- Kaiser San Rafael-Gallinas - San Rafael, California, United States
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara, California, United States
- Kaiser Permanente-Santa Rosa - Santa Rosa, California, United States
- Kaiser Permanente Cancer Treatment Center - South San Francisco, California, United States
- Kaiser Permanente-South San Francisco - South San Francisco, California, United States
- Kaiser Permanente-Stockton - Stockton, California, United States
- Torrance Memorial Physician Network - Cancer Care - Torrance, California, United States
- Kaiser Permanente Medical Center-Vacaville - Vacaville, California, United States
- Kaiser Permanente-Vallejo - Vallejo, California, United States
- Kaiser Permanente-Walnut Creek - Walnut Creek, California, United States
- UCHealth University of Colorado Hospital - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs, Colorado, United States
- UCHealth Memorial Hospital Central - Colorado Springs, Colorado, United States
- Memorial Hospital North - Colorado Springs, Colorado, United States
- UCHealth Highlands Ranch Hospital - Highlands Ranch, Colorado, United States
- Helen F Graham Cancer Center - Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA - Newark, Delaware, United States
- Christiana Care Health System-Wilmington Hospital - Wilmington, Delaware, United States
- George Washington University Medical Center - Washington D.C., District of Columbia, United States
- Mount Sinai Comprehensive Cancer Center at Aventura - Aventura, Florida, United States
- Bay Pines VA Healthcare System - Bay Pines, Florida, United States
- Jupiter Medical Center - Jupiter, Florida, United States
- Mount Sinai Medical Center - Miami Beach, Florida, United States
- Moffitt Cancer Center at SouthShore - Ruskin, Florida, United States
- Moffitt Cancer Center-International Plaza - Tampa, Florida, United States
- Moffitt Cancer Center - McKinley Campus - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center at Wesley Chapel - Wesley Chapel, Florida, United States
- Grady Health System - Atlanta, Georgia, United States
Showing 60 of 413 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →