A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
OBJECTIVES:
Primary
- Demonstrate an overall survival (OS) advantage in patients with intermediate-risk
prostate cancer treated with dose-escalated radiotherapy (RT) with versus without
short-term androgen-deprivation therapy (ADT).
Secondary
- Determine whether the addition of ADT to dose-escalated RT versus RT alone improves
clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of
salvage ADT, and prostate cancer-specific mortality in these patients.
- Estimate the magnitude of benefit of ADT with respect to OS in patients treated with
different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate
brachytherapy boost vs high-dose rate brachytherapy boost).
- Compare acute and late treatment adverse events of these regimens and correlate these
events with the presence or absence of pre-existing comorbidity as documented by the
Adult Comorbidity Evaluation 27 assessment.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are
stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs
< 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and
low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments).
Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy
implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at
discretion of treating physician and may include either 3D-conformal RT or
intensity-modulated RT.
- Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone
releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin)
subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy
(flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks
after the first LHRH injection, patients undergo radiotherapy as in arm I.
After completion of study therapy, patients are followed up periodically.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival (OS)
No
Alvaro A. Martinez, MD, FACR
Study Chair
21st Century Oncology - Michigan Institute for Radiation Oncology
Unspecified
CDR0000648194
NCT00936390
September 2009
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
St. John Macomb Hospital | Warren, Michigan 48093 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
University of California Davis Cancer Center | Sacramento, California 95817 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Lourdes Regional Cancer Center | Binghamton, New York 13905 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Cancer Treatment Center | Wooster, Ohio 44691 |
West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Community Cancer Center | Elyria, Ohio 44035 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
Easton Regional Cancer Center at Easton Hospital | Easton, Pennsylvania 18042 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Regional Cancer Center - Erie | Erie, Pennsylvania 16505 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
St. John's Regional Medical Center | Joplin, Missouri 64804 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
Center for Cancer Care and Research at Watson Clinic, LLP | Lakeland, Florida 33805 |
Mercy General Hospital | Sacramento, California 95819 |
Memorial Medical Center | Modesto, California 95355 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
Mitchell Memorial Cancer Center at Owensboro Medical Health System | Owensboro, Kentucky 42303 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
Trinity CancerCare Center | Minot, North Dakota 58701 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
Franciscan Skemp Healthcare - La Crosse Campus | La Crosse, Wisconsin 54601 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Providence Cancer Center at PMCC | Medford, Oregon 97504 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Central Maryland Oncology Center | Columbia, Maryland 21044 |
Cancer Centers of North Carolina - Raleigh | Raleigh, North Carolina 27607 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
Immanuel St. Joseph's | Mankato, Minnesota 56002 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |
University Medical Center at Princeton | Princeton, New Jersey 08540 |
Emory Crawford Long Hospital | Atlanta, Georgia 30308 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Hudson Valley Oncology Associates | Poughkeepsie, New York 12601 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
University Radiation Oncology at Parkridge Hospital | Rochester, New York 14626 |
Coleman Radiation Oncology Center at Carter General Hospital | Morehead City, North Carolina 28557 |
CarolinaEast Cancer Care | New Bern, North Carolina 28560 |
South Atlantic Radiation Oncology, LLC | Supply, North Carolina 28462 |
Coastal Carolina Radiation Oncology Center | Wilmington, North Carolina 28401 |
Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Longview Cancer Center | Longview, Texas 75601 |
Piedmont Fayette Hospital | Fayetteville, Georgia 30214 |
Clemens Regional Medical Center | Mount Clemens, Michigan 48043 |
Lakeside Hospital | Omaha, Nebraska 68130 |
University of New Mexico Cancer Center - South | Las Cruces, New Mexico 88011 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Saint Helena Hospital | Saint Helena, California 94574 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Arizona Center for Cancer Care - Peoria | Peoria, Arizona 85381 |
Feather River Hospital Cancer Center | Paradise, California 95969 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
McLaren Cancer Institute | Flint, Michigan 48532 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Texas Oncology, PA at Harris Center HEB | Bedford, Texas 76022 |
Texas Oncology, PA at Texas Cancer Center - Denton South | Denton, Texas 76210 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Bloomington Hospital Regional Cancer Institute | Bloomington, Indiana 47403 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Tate Cancer Center at Baltimore Washington Medical Center | Glen Burnie, Maryland 21061 |
Robinson Radiation Oncology | Ravenna, Ohio 44266 |
Saint Agnes Cancer Center at Saint Agnes Medical Center | Fresno, California 93720 |
Coastal Cancer Center at Sentara Virginia Beach General Hospital | Virginia Beach, Virginia 23454 |
Veterans Affairs Medical Center - Tampa | Tampa, Florida 33612 |
Memorial Hermann Hospital - Memorial City | Houston, Texas 77024 |
Texas Oncology, PA - Wichita Falls | Wichita Falls, Texas 76310 |
Zangmeister Center | Columbus, Ohio 43219 |
Great Lakes Cancer Institute - Lapeer Campus | Lapeer, Michigan 48446 |
St. Peter's Hospital | Albany, New York 12208 |
RMH Regional Cancer Center at Rockingham Memorial Hospital | Harrisonburg, Virginia 22801 |