397
Participants
Start Date
January 31, 2000
Primary Completion Date
April 30, 2010
Study Completion Date
November 30, 2013
bicalutamide
Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
estramustine phosphate sodium
280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
etoposide
50 mg/m\^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
flutamide
Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
paclitaxel
135 mg/m\^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
Luteinizing hormone releasing hormone [LHRH] agonist
Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
Radiation therapy
Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
warfarin
To keep international normalized ratio (INR) \> 1.5 and \< 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
Herbert Irving Comprehensive Cancer Center at Columbia University, New York
CCOP - North Shore University Hospital, Manhasset
Wellspan Health - York Cancer Center, York
St. Luke's Hospital Cancer Center, Bethlehem
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown
Delaware County Memorial Hospital, Drexel Hill
CCOP - MainLine Health, Wynnewood
Fox Chase Cancer Center, Philadelphia
Greater Baltimore Medical Center and Cancer Center, Baltimore
Anne Arundel Oncology Center, Annapolis
CCOP - Columbus, Columbus
Akron General Medical Center, Akron
Akron City Hospital, Akron
CCOP - Dayton, Dayton
West Michigan Cancer Center, Kalamazoo
Marquette General Hospital, Marquette
St. Luke's Medical Center, Milwaukee
Medical College of Wisconsin Cancer Center, Milwaukee
All Saints Cancer Center at All Saints Healthcare, Racine
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse
CCOP - Metro-Minnesota, Saint Louis Park
Lutheran General Cancer Care Center, Park Ridge
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia
CCOP - Ochsner, New Orleans
Mary Bird Perkins Cancer Center, Baton Rouge
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver
LDS Hospital, Salt Lake City
Dixie Regional Medical Center, St. George
Foundation for Cancer Research and Education, Phoenix
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas
Sutter Health Western Division Cancer Research Group, Greenbrae
CCOP - Santa Rosa Memorial Hospital, Santa Rosa
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham
Mount Diablo Medical Center, Concord
Baptist Hospital of Miami, Miami
Methodist Cancer Center at Methodist Hospital, Indianapolis
Ball Memorial Hospital Cancer Center, Muncie
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington
University of Michigan Comprehensive Cancer Center, Ann Arbor
Veterans Affairs Medical Center - East Orange, East Orange
Monmouth Medical Center, Long Branch
South Jersey Regional Cancer Center, Millville
Atlantic City Medical Center, Pomona
Fox Chase Cancer Center at St. Francis Medical Center, Trenton
Arthur G. James Cancer Hospital - Ohio State University, Columbus
CCOP - Toledo Community Hospital, Toledo
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia
Albert Einstein Cancer Center, Philadelphia
University of Texas - MD Anderson Cancer Center, Houston
University Cancer Center at University of Washington Medical Center, Seattle
St. Vincent Hospital, Green Bay
Saint John Regional Hospital, Saint John
Cancer Care Ontario-London Regional Cancer Centre, London
National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK