Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Launched by NRG ONCOLOGY · Jul 6, 2023
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to treat high-risk prostate cancer using a method called stereotactic body radiation therapy (SBRT). Instead of the usual radiation therapy, which can take up to 9 weeks with many treatments, SBRT delivers radiation in just five sessions over two weeks. The goal is to see if this shorter, more intense treatment can effectively kill cancer cells and prevent the cancer from returning, just as well as the traditional longer treatment.
To participate in this trial, men aged 18 and older with a confirmed diagnosis of prostate cancer may be eligible if they have certain high-risk factors, such as a specific type of tumor or a high level of a marker called PSA. Participants will receive the SBRT treatment and will be monitored to see how well it works. It's important to note that patients must meet specific criteria, such as not having previous radiation treatment in the same area or evidence of cancer spread outside the pelvic area. This trial is currently recruiting participants, so if you think you might qualify, it's worth discussing with your doctor.
Gender
MALE
Eligibility criteria
- 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
- • 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
- • Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Boston, Massachusetts, United States
Washington, District Of Columbia, United States
Saint Louis, Missouri, United States
Flint, Michigan, United States
Flint, Michigan, United States
Edina, Minnesota, United States
Baton Rouge, Louisiana, United States
Newark, New Jersey, United States
Toms River, New Jersey, United States
Salt Lake City, Utah, United States
Little Rock, Arkansas, United States
Fort Sam Houston, Texas, United States
Oklahoma City, Oklahoma, United States
Long Branch, New Jersey, United States
Cleveland, Ohio, United States
Traverse City, Michigan, United States
Delaware, Ohio, United States
Ogden, Utah, United States
Houston, Texas, United States
Urbana, Illinois, United States
Ann Arbor, Michigan, United States
Saint Paul, Minnesota, United States
Grand Forks, North Dakota, United States
Effingham, Illinois, United States
Springfield, Illinois, United States
Downers Grove, Illinois, United States
Portland, Oregon, United States
Hazel Crest, Illinois, United States
Springfield, Illinois, United States
Boston, Massachusetts, United States
Honolulu, Hawaii, United States
Rochester, New York, United States
Valhalla, New York, United States
Danville, Pennsylvania, United States
Salt Lake City, Utah, United States
Birmingham, Alabama, United States
Orange, California, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Burlington, Vermont, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Morgantown, West Virginia, United States
Provo, Utah, United States
Cape Girardeau, Missouri, United States
Honolulu, Hawaii, United States
Livingston, New Jersey, United States
Berlin, Vermont, United States
Beverly Hills, California, United States
Milwaukee, Wisconsin, United States
Oak Lawn, Illinois, United States
Oakland, California, United States
Park Ridge, Illinois, United States
Stony Brook, New York, United States
Sioux Falls, South Dakota, United States
Richmond, Virginia, United States
Saint Louis, Missouri, United States
Toledo, Ohio, United States
Green Bay, Wisconsin, United States
Honolulu, Hawaii, United States
Portland, Oregon, United States
Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Rochester, New York, United States
Seattle, Washington, United States
Los Angeles, California, United States
Stillwater, Minnesota, United States
Great Falls, Montana, United States
Wilkes Barre, Pennsylvania, United States
Spartanburg, South Carolina, United States
Rohnert Park, California, United States
Sacramento, California, United States
Canandaigua, New York, United States
Fremont, California, United States
Richmond, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
Santa Clara, California, United States
Santa Rosa, California, United States
South San Francisco, California, United States
Stockton, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Jupiter, Florida, United States
'Aiea, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Galesburg, Illinois, United States
Wichita, Kansas, United States
Portland, Maine, United States
Bemidji, Minnesota, United States
Springfield, Missouri, United States
Billings, Montana, United States
Newark, New Jersey, United States
Akron, Ohio, United States
Mentor, Ohio, United States
Sylvania, Ohio, United States
Portland, Oregon, United States
Ephrata, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
American Fork, Utah, United States
Cedar City, Utah, United States
Murray, Utah, United States
Burlington, Vermont, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Rhinelander, Wisconsin, United States
Sheboygan, Wisconsin, United States
Stevens Point, Wisconsin, United States
West Allis, Wisconsin, United States
Quebec City, Quebec, Canada
Columbus, Ohio, United States
Columbus, Ohio, United States
York, Pennsylvania, United States
Huntington, West Virginia, United States
Antigo, Wisconsin, United States
Wausau, Wisconsin, United States
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Libertyville, Illinois, United States
Livonia, Michigan, United States
Mansfield, Ohio, United States
Toronto, Ontario, Canada
Kailua, Hawaii, United States
Clackamas, Oregon, United States
Oshkosh, Wisconsin, United States
Albuquerque, New Mexico, United States
Duluth, Minnesota, United States
Saint John, New Brunswick, Canada
Elgin, Illinois, United States
Carthage, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Warrenville, Illinois, United States
Lake Success, New York, United States
Grafton, Wisconsin, United States
Atlanta, Georgia, United States
Mount Kisco, New York, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Geneva, Illinois, United States
Pekin, Illinois, United States
Scarborough, Maine, United States
Bend, Oregon, United States
Erie, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Greenwood, South Carolina, United States
Saint George, Utah, United States
Burlington, Wisconsin, United States
Germantown, Wisconsin, United States
Green Bay, Wisconsin, United States
Kenosha, Wisconsin, United States
Marinette, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Summit, Wisconsin, United States
Two Rivers, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Wisconsin Rapids, Wisconsin, United States
York, Pennsylvania, United States
Gettysburg, Pennsylvania, United States
Vacaville, California, United States
Goshen, Indiana, United States
Saint Louis, Missouri, United States
Pennington, New Jersey, United States
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Antioch, California, United States
Fresno, California, United States
Modesto, California, United States
Oakland, California, United States
Rancho Cordova, California, United States
Roseville, California, United States
South San Francisco, California, United States
Atlanta, Georgia, United States
Lihue, Hawaii, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Parma, Ohio, United States
New Richmond, Wisconsin, United States
Delaware, Ohio, United States
Brooklyn, New York, United States
Aarau, , Switzerland
Saint Peters, Missouri, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Chai Wan, , Hong Kong
New York, New York, United States
Great Falls, Montana, United States
Sugar Land, Texas, United States
Newark, Delaware, United States
Newark, Delaware, United States
Wilmington, Delaware, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Dublin, Ohio, United States
Marion, Ohio, United States
Lewisburg, Pennsylvania, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Flushing, New York, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Conroe, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Sturgeon Bay, Wisconsin, United States
Pottsville, Pennsylvania, United States
Milford, Massachusetts, United States
Richmond, Virginia, United States
Birmingham, Alabama, United States
Dublin, California, United States
Fresno, California, United States
Sacramento, California, United States
San Rafael, California, United States
South Weymouth, Massachusetts, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Ravenna, Ohio, United States
Lebanon, Pennsylvania, United States
Gaffney, South Carolina, United States
Greer, South Carolina, United States
Union, South Carolina, United States
Riverton, Utah, United States
Milwaukee, Wisconsin, United States
New Brunswick, New Jersey, United States
Farmington, Utah, United States
Milwaukee, Wisconsin, United States
Elizabethtown, Kentucky, United States
Fishersville, Virginia, United States
Menomonee Falls, Wisconsin, United States
West Bend, Wisconsin, United States
Carlisle, Pennsylvania, United States
Atlanta, Georgia, United States
Chambersburg, Pennsylvania, United States
Midlothian, Virginia, United States
Glen Burnie, Maryland, United States
Bay Shore, New York, United States
Bath, Maine, United States
Sanford, Maine, United States
Baltimore, Maryland, United States
Dekalb, Illinois, United States
New Bern, North Carolina, United States
Honolulu, Hawaii, United States
Jersey City, New Jersey, United States
Mechanicsville, Virginia, United States
Farrell, Pennsylvania, United States
Mechanicsburg, Pennsylvania, United States
Oak Creek, Wisconsin, United States
Chadds Ford, Pennsylvania, United States
Libertyville, Illinois, United States
Redwood City, California, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Atlanta, Georgia, United States
Tuscaloosa, Alabama, United States
'Ewa Beach, Hawaii, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Sleepy Hollow, New York, United States
New York, New York, United States
Torrance, California, United States
Greenlawn, New York, United States
Alton, Illinois, United States
'Aiea, Hawaii, United States
Springfield, Illinois, United States
Dansville, New York, United States
Lexington, Kentucky, United States
Shiloh, Illinois, United States
Sheboygan, Wisconsin, United States
Seattle, Washington, United States
Avon, Ohio, United States
Lebanon, New Hampshire, United States
Sheboygan, Wisconsin, United States
Wyoming, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Webster, New York, United States
Danville, Illinois, United States
Forest Hills, New York, United States
Decatur, Georgia, United States
Ames, Iowa, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Palos Heights, Illinois, United States
Niles, Michigan, United States
Saint Joseph, Michigan, United States
O'fallon, Illinois, United States
Lansing, Michigan, United States
Milwaukee, Wisconsin, United States
Grand Rapids, Michigan, United States
Saint Joseph, Michigan, United States
Saint Johnsbury, Vermont, United States
Royal Oak, Michigan, United States
Irvine, California, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
Saginaw, Michigan, United States
Aurora, Illinois, United States
Havre, Montana, United States
Largo, Maryland, United States
Sheboygan, Wisconsin, United States
Union, South Carolina, United States
Portland, Maine, United States
Scarborough, Maine, United States
Patients applied
Trial Officials
Karen E Hoffman
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported