Spots Global Cancer Trial Database for A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
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Trial Identification
Brief Title: A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
Official Title: STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features
Study ID: NCT03809000
Conditions
Study Description
Brief Summary: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.
Detailed Description: PRIMARY OBJECTIVE: To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
Arizona Center for Cancer Care - Peoria, Peoria, Arizona, United States
Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona, United States
Arizona Center for Cancer Care - Scottsdale East, Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Scottsdale North, Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Surprise, Surprise, Arizona, United States
Marin Cancer Care, Inc., Greenbrae, California, United States
Marin Health Medical Center, Greenbrae, California, United States
University of Southern California, Los Angeles, California, United States
USC Medical Center - Los Angeles County, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Roseville Radiation Oncology Center, Roseville, California, United States
Sutter Roseville Medical Center, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California, San Francisco, San Francisco, California, United States
Valley View Hospital Cancer Center, Glenwood Springs, Colorado, United States
University of Florida Health Science Center, Gainesville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Nancy N. & J.C. Lewis Cancer & Research Pavilion, Savannah, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Kansas University Cancer Center Overland Park, Overland Park, Kansas, United States
Kansas University Cancer Center Westwood, Westwood, Kansas, United States
East Jefferson General Hospital, Metairie, Louisiana, United States
LSU Healthcare Network/Metairie Multi-Specialty Clinic, Metairie, Louisiana, United States
Coastal Cancer Treatment Center - Bath, Bath, Maine, United States
Waldo Count General Hospital - Belfast, Belfast, Maine, United States
Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford, Biddeford, Maine, United States
Maine Health/Stephens Memorial - Norway, Norway, Maine, United States
Maine Medical Center - Bramhall S Portland, Portland, Maine, United States
Penobscot Bay Medical Center - Rockport, Rockport, Maine, United States
Maine Health CC of York County - Sanford, Sanford, Maine, United States
Maine Health/SMHCancer Care and Blood Disorders - Sanford, Sanford, Maine, United States
Maine Medical Cancer Center - Scarborough Campus, Scarborough, Maine, United States
Maine Medical Partners - South Portland, South Portland, Maine, United States
McLaren Cancer Institute - Bloomfield, Bloomfield, Michigan, United States
21st Century Oncology MHP - Clarkston, Clarkston, Michigan, United States
McLaren Cancer Institute - Clarkston, Clarkston, Michigan, United States
William Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Wayne State/Karmanos Cancer Institute, Detroit, Michigan, United States
21st Century Oncology MHP - Farmington, Farmington Hills, Michigan, United States
McLaren Cancer Institute - Flint, Flint, Michigan, United States
Singh and Arora Hematology Oncology PC, Flint, Michigan, United States
McLaren Cancer Institute - Greater Lansing, Lansing, Michigan, United States
Mid-Michigan Physicians - Lansing, Lansing, Michigan, United States
McLaren Cancer Institute - Lapeer Region, Lapeer, Michigan, United States
21st Century Oncology MHP - Macomb, Macomb, Michigan, United States
21st Century Oncology MHP - Madison Heights, Madison Heights, Michigan, United States
McLaren Cancer Institute - Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute - Central Michigan, Mount Pleasant, Michigan, United States
McLaren Cancer Institute - Owosso, Owosso, Michigan, United States
McLaren Cancer Institute - Northern Michigan, Petoskey, Michigan, United States
McLaren Cancer Institute - Port Huron, Port Huron, Michigan, United States
William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, United States
William Beaumont Hospital - Troy, Sterling Heights, Michigan, United States
21st Century Oncology MHP - Troy, Troy, Michigan, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology PA - Maplewood, Maplewood, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
HealthPartners, Inc., Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Kansas University Cancer Center North, Kansas City, Missouri, United States
Kansas University Cancer Center Lee's Summit, Lee's Summit, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Exeter Hospital, Exeter, New Hampshire, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
University Physicians at Oneida, Oneida, New York, United States
Upstate Cancer Center Radiation Oncology at Oneida, Oneida, New York, United States
University Physicians at Oswego, Oswego, New York, United States
Upstate Cancer Radiation Oncology at Oswego, Oswego, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Upstate Cancer Center at Hill Radiation Oncology, Syracuse, New York, United States
UNC Rex Cancer Center, Raleigh, North Carolina, United States
Rex Cancer Center of Wakefield, Raleigh, North Carolina, United States
WellSpan Health - Ephrata Cancer Center, Ephrata, Pennsylvania, United States
WellSpan Health - Adams Cancer Center, Gettysburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
WellSpan Health - Sechler Family Cancer Center, Lebanon, Pennsylvania, United States
University of Pittsburgh Medical Center - Shadyside Hospital, Pittsburgh, Pennsylvania, United States
WellSpan Health - York Hospital, York, Pennsylvania, United States
Gibbs Cancer Center - Pelham, Greer, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
UT Southwestern/Simmons Cancer Center - Dallas, Dallas, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Cedar City Hospital, Cedar City, Utah, United States
Logan Regional Medical Center, Logan, Utah, United States
Intermountain Medical Center, Murray, Utah, United States
Utah Valley Regional Medical Center, Provo, Utah, United States
Dixie Regional Medical Center, Saint George, Utah, United States
Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury, Saint Johnsbury, Vermont, United States
Sentara Cancer Institute at Sentara CarePlex Hospital, Hampton, Virginia, United States
Sentara Norfolk General Hospital, Norfolk, Virginia, United States
Sentara Virginia Beach General Hospital, Virginia Beach, Virginia, United States
Aspirus Langlade Hospital, Antigo, Wisconsin, United States
University Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Drexel Town Square, Oak Creek, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Froedtert West Bend Hospital, West Bend, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States
CHU de Quebec - L'Hotel-Dieu de Quebec, Québec City, Quebec, Canada
CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, , Canada
Contact Details
Name: Edwin Posadas, MD
Affiliation: RTOG Foundation
Role: PRINCIPAL_INVESTIGATOR
Name: Hiram Gay, MD
Affiliation: RTOG Foundation
Role: PRINCIPAL_INVESTIGATOR
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