Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Launched by RADIATION THERAPY ONCOLOGY GROUP · Feb 26, 2004
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
OBJECTIVES: Primary: To evaluate whether a combination of Zoladex and flutamide used as cytoreductive agents prior to and during definitive radiation therapy improves overall survival over radiation therapy alone in locally confined carcinomas of the prostate; Secondary: To compare the rates of disease-specific survival, clinical relapse (local progression and/or distant failure), freedom from prostate-specific antigen (PSA) failure, freedom from second clinical relapse, freedom from second PSA relapse, and disease-free survival; To compare the prostate re-biopsy at two years; To measure th...
Gender
MALE
Eligibility criteria
- Inclusion criteria:
- • Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b.
- • Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0).
- • Karnofsky performance status ≥ 70.
- • PSA is mandatory, must be ≤ 20)
- • No prior hormonal therapy, radiation or chemotherapy.
- • Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization.
- • Prior testosterone administration allowed if at least 90 days elapsed since last administration.
- • No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman.
- • Treatment begins within 21 days after randomization.
- • Patients signs a study-specific informed consent form.
- • Alanine Aminotransferase (ALT) within 2x upper normal limits.
- Exclusion criteria:
- • Stage T1a or ≥ T2c disease.
- • Lymph node involvement (N1 - N3).
- • Evidence of distant metastasis. (M1)
- • PSA \> 20.
- • Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy.
- • Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma.
- • Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry.
- • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- • Karnofsky performance status of \< 70.
About Radiation Therapy Oncology Group
The Radiation Therapy Oncology Group (RTOG) is a leading clinical trial sponsor dedicated to advancing the field of radiation oncology through rigorous research and collaboration. Established to improve patient outcomes, RTOG conducts multicenter clinical trials that evaluate innovative radiation treatment techniques, assess the efficacy of combined modality therapies, and enhance quality of life for cancer patients. Committed to scientific excellence, RTOG fosters partnerships among academic institutions, healthcare providers, and industry stakeholders, ensuring that findings translate into clinical practice to optimize cancer care and improve survival rates.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marshfield, Wisconsin, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Akron, Ohio, United States
Tucson, Arizona, United States
Buffalo, New York, United States
New York, New York, United States
Calgary, Alberta, Canada
Fleurimont, Quebec, Canada
Bronx, New York, United States
Houston, Texas, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Montreal, Quebec, Canada
Los Angeles, California, United States
Denver, Colorado, United States
Washington, District Of Columbia, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Albany, New York, United States
Brooklyn, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Milwaukee, Wisconsin, United States
Miami, Florida, United States
Flint, Michigan, United States
Greenville, North Carolina, United States
Burlington, Vermont, United States
Atlanta, Georgia, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
La Jolla, California, United States
San Francisco, California, United States
Wilmington, Delaware, United States
Miami Beach, Florida, United States
Baltimore, Maryland, United States
Columbia, Missouri, United States
Lebanon, New Hampshire, United States
Manhasset, New York, United States
Winston Salem, North Carolina, United States
Memphis, Tennessee, United States
Indianapolis, Indiana, United States
Kalamazoo, Michigan, United States
Saint Louis Park, Minnesota, United States
East Orange, New Jersey, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Danville, Pennsylvania, United States
Nashville, Tennessee, United States
Orlando, Florida, United States
Maywood, Illinois, United States
New Orleans, Louisiana, United States
Toledo, Ohio, United States
Rapid City, South Dakota, United States
Birmingham, Alabama, United States
Iowa City, Iowa, United States
Winston Salem, North Carolina, United States
Charlottesville, Virginia, United States
Edmonton, , Canada
Saskatoon, , Canada
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Concord, California, United States
Fresno, California, United States
Fresno, California, United States
Glendale, California, United States
Greenbrae, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Oakland, California, United States
Pomona, California, United States
Sacramento, California, United States
San Jose, California, United States
Santa Rosa, California, United States
Colorado Springs, Colorado, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Orange Park, Florida, United States
Panama City, Florida, United States
Sarasota, Florida, United States
Columbus, Georgia, United States
Rome, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Harvey, Illinois, United States
Park Ridge, Illinois, United States
Peoria, Illinois, United States
Anderson, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Dubuque, Iowa, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Baton Rouge, Louisiana, United States
Lafayette, Louisiana, United States
New Orleans, Louisiana, United States
Portland, Maine, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Hyannis, Massachusetts, United States
Jamaica Plain, Massachusetts, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
Springfield, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Manchester, New Hampshire, United States
Edison, New Jersey, United States
Newark, New Jersey, United States
Toms River, New Jersey, United States
Trenton, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Clifton Springs, New York, United States
New York, New York, United States
Plattsburgh, New York, United States
Poughkeepsie, New York, United States
Valhalla, New York, United States
Concord, North Carolina, United States
Hickory, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Darby, Pennsylvania, United States
Drexel Hill, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Scranton, Pennsylvania, United States
Wilkes Barre, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
York, Pennsylvania, United States
Providence, Rhode Island, United States
Greenville, South Carolina, United States
Jackson, Tennessee, United States
Amarillo, Texas, United States
Beaumont, Texas, United States
Galveston, Texas, United States
Lackland Air Force Base, Texas, United States
Lubbock, Texas, United States
Pasadena, Texas, United States
Tyler, Texas, United States
Saint George, Utah, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Rutland, Vermont, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Yakima, Washington, United States
Green Bay, Wisconsin, United States
La Crosse, Wisconsin, United States
Madison, Wisconsin, United States
Madison, Wisconsin, United States
Menomonee Falls, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Waukesha, Wisconsin, United States
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Sudbury, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Decatur, Illinois, United States
Mobile, Alabama, United States
Duarte, California, United States
Los Angeles, California, United States
New Orleans, Louisiana, United States
New York, New York, United States
Huntsville, Alabama, United States
Anchorage, Alaska, United States
San Diego, California, United States
Panama City, Florida, United States
Tallahassee, Florida, United States
Elgin, Illinois, United States
Salisbury, Maryland, United States
Midland, Michigan, United States
Royal Oak, Michigan, United States
Tupelo, Mississippi, United States
Omaha, Nebraska, United States
Elizabeth, New Jersey, United States
Long Branch, New Jersey, United States
Millville, New Jersey, United States
Mount Holly, New Jersey, United States
New Brunswick, New Jersey, United States
Pomona, New Jersey, United States
Warren, New Jersey, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Salt Lake City, Utah, United States
Harrisonburg, Virginia, United States
Wheeling, West Virginia, United States
Vancouver, British Columbia, Canada
St. Johns, Newfoundland And Labrador, Canada
Ottawa, Ontario, Canada
Tuscaloosa, Alabama, United States
Miami, Florida, United States
Camden, New Jersey, United States
Trenton, New Jersey, United States
Patients applied
Trial Officials
David G. McGowan, MD
Study Chair
Cross Cancer Institute at University of Alberta
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials