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Last Modified: 11/13/2009     First Published: 5/19/2006  
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Phase III Randomized Study of Hypofractionated Versus Conventionally Fractionated Three-Dimensional Conformal or Intensity-Modulated Radiotherapy in Patients With Favorable-Risk Stage II Prostate Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCIRTOG-0415
NCT00331773

Special Category: NCI Web site featured trial, CTSU trial

Objectives

Primary

  1. Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).

Secondary

  1. Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
  2. Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
  3. Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens.
  4. Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .
  5. Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens.
  6. Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed adenocarcinoma of the prostate within the past 6 months
    • Clinical stage T1-2c
  • Combined Gleason score 2-6
  • Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months
    • No PSA measurement for ≥ 10 days after prostate biopsy
    • No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation of dutasteride)
  • No regional lymph node involvement
  • No distant metastases

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior radical prostatectomy or cryosurgery for prostate cancer
  • No prior hormonal therapy, including any of the following:
    • Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
    • Antiandrogens (e.g., flutamide or bicalutamide)
    • Estrogens (e.g., diethylstilbestrol [DES])
    • Surgical castration (bilateral orchiectomy)
  • No prior pelvic radiotherapy or prostate brachytherapy
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • At least 30 days since prior finasteride
  • At least 90 days since prior dutasteride
  • No concurrent neoadjuvant or adjuvant hormonal therapy
  • Concurrent warfarin or other blood-thinning agents allowed

Patient Characteristics:

  • Zubrod performance status 0-1
  • No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months
  • No acute bacterial or fungal infection requiring IV antibiotics
  • No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
  • No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • No known AIDS
  • No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
  • No other severe, active comorbidity

Expected Enrollment

1067

A total of 1,067 patients will be accrued to this study.

Outcomes

Primary Outcome(s)

Disease-free survival at 5 years as measured by Kaplan-Meier

Secondary Outcome(s)

Time to failure
Disease-specific survival
Freedom from biochemical recurrence (FFBR)
Overall survival
Incidence of GU and GI acute and late toxicity
Statistical modeling of genomic biomarkers
Comparison of disease-specific HRQOL change in EPIC; the Utilization of Sexual Medications/Devices supplements the EPIC
Assessment of anxiety and depression change using the HSCL-25
Evaluation and comparison of the cost-utility of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis
Collection of paraffin-embedded tissue block, serum, plasma, and buffy coat cells for future translational research analyses

Outline

This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs 4-9 ng/mL), and planned radiotherapy modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).
  • Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).

Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

W. Robert Lee, MD, Protocol chair
Ph: 919-668-7342

Trial Sites

U.S.A.
Arizona
  Phoenix
 Arizona Oncology Services Foundation
 David Brachman, MD, FACRO
Ph: 602-274-4484
  Tucson
 Arizona Oncology - Tucson
 Vivek Kavadi
Ph: 520-797-4468
California
  Auburn
 Auburn Radiation Oncology
 Seth Rosenthal
Ph: 916-888-1266
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center
Ph: 510-204-3428
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
  Burlingame
 Peninsula Medical Center
 David Irwin, MD
Ph: 510-204-1591
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Seth Rosenthal
Ph: 916-622-9700
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Seth Rosenthal
Ph: 916-904-3440
  Castro Valley
 East Bay Radiation Oncology Center
 James Feusner, MD
Ph: 510-428-3689
 Valley Medical Oncology Consultants - Castro Valley
 James Feusner, MD
Ph: 510-428-3689
  Fremont
 Valley Medical Oncology
 James Feusner, MD
Ph: 510-428-3689
  Greenbrae
 Marin Cancer Institute at Marin General Hospital
 David Irwin, MD
Ph: 510-204-1591
 Sutter Health - Western Division Cancer Research Group
 David Irwin, MD
Ph: 510-204-1591
  Hayward
 Kaiser Permanente Medical Center - Hayward
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Long Beach
 Veterans Affairs Medical Center - Long Beach
 Samar Azawi, MD
Ph: 562-826-5606
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Michael Girvigian
Ph: 323-667-4011
800-954-8000
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus
Ph: 510-204-1414
 Bay Area Breast Surgeons, Incorporated
 James Feusner, MD
Ph: 510-428-3689
 CCOP - Bay Area Tumor Institute
 James Feusner, MD
Ph: 510-428-3689
 Kaiser Permanente - Division of Research - Oakland
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Kaiser Permanente Medical Center - Oakland
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Larry G Strieff MD Medical Corporation
 James Feusner, MD
Ph: 510-428-3689
 Tom K Lee, Incorporated
 James Feusner, MD
Ph: 510-428-3689
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 James Feusner, MD
Ph: 510-428-3689
  Rancho Cardova
 Kaiser Permanente Medical Center - Rancho Cordova
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Redwood City
 Kaiser Permanente Medical Center - Redwood City
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Rohnert Park
 Rohnert Park Cancer Center
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Radiation Oncology Center - Roseville
 Seth Rosenthal
Ph: 916-969-4422
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Mercy General Hospital
 Seth Rosenthal
Ph: 916-453-4453
 Radiological Associates of Sacramento Medical Group, Incorporated
 Seth Rosenthal
Ph: 916-646-8300
 South Sacramento Cancer Center
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 South Sacramento Kaiser-Permanente Medical Center
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 University of California Davis Cancer Center
 Clinical Trials Office - University of California Davis Cancer Center
Ph: 916-734-3089
  San Francisco
 California Pacific Medical Center - California Campus
 David Irwin, MD
Ph: 510-204-1591
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James Feusner, MD
Ph: 510-428-3689
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Santa Clara
 Louis Fehrenbacher, MD
Ph: 707-651-2577
 Kaiser Permanente Medical Center - Santa Clara Kiely Campus
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Santa Rosa
 Kaiser Permanente Medical Center - Santa Rosa
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Stockton
 Kaiser Permanente Medical Facility - Stockton
 Louis Fehrenbacher, MD
Ph: 707-651-2577
  Travis AFB
 General Robert Huyser Cancer Center at David Grant Medical Center
 Roland Engel, MD
Ph: 707-423-7691
  Vacaville
 Solano Radiation Oncology Center
 Seth Rosenthal
Ph: 707-447-0400
  Vallejo
 Sutter Solano Medical Center
 David Irwin, MD
Ph: 510-204-1591
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Louis Fehrenbacher, MD
Ph: 707-651-2577
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Rocky Mountain Cancer Centers - Aurora
 Vivek Kavadi
Ph: 303-418-7600
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Fort Collins
 Poudre Valley Radiation Oncology
 C. Kelley Simpson, MD
Ph: 970-482-3328
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Thornton
 North Suburban Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Delaware
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
Florida
  Gainesville
 University of Florida Shands Cancer Center
 Clinical Trials Office - University of Florida Shands Cancer Center
Ph: 888-254-7581
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Miami
 Baptist-South Miami Regional Cancer Program
 Andre Abitbol, MD
Ph: 786-596-6566
  Panama City
 Bay Medical
 Hasan Murshed
Ph: 850-747-6972
Georgia
  Altanta
 Winship Cancer Institute of Emory University
 Ashesh Jani
Ph: 773-702-2526
  Atlanta
 Emory Crawford Long Hospital
 Ashesh Jani
Ph: 773-702-2526
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Ashesh Jani
Ph: 773-702-2526
  Decatur
 Veterans Affairs Medical Center - Atlanta (Decatur)
 Scott Edelman
Ph: 404-728-7680
Illinois
  Alton
 Saint Anthony's Hospital at Saint Anthony's Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3605
  Chicago
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-6601
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3605
  Olympia Fields
 Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
 Clinical Trials Office - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Ph: 708-679-2217
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3605
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3605
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3605
 John Kugler, MD
Ph: 309-243-3605
Indiana
  Indianapolis
 Central Indiana Cancer Centers - East
 Vivek Kavadi
Ph: 317-964-5200
 Methodist Cancer Center at Methodist Hospital
 Contact Person
Ph: 317-962-8288
800-265-3220
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa
Ph: 641-422-6304
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709
  Overland Park
 Kansas City Cancer Centers - Southwest
 Vivek Kavadi
Ph: 913-234-0400
Kentucky
  Louisville
 James Graham Brown Cancer Center at University of Louisville
 William Spanos, Jr.
Ph: 502-562-4158
866-530-5516
 Norton Suburban Hospital
 Mark Cornett
Ph: 502-893-1000
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center
Ph: 800-888-8823
  Columbia
 Central Maryland Oncology Center
 Young Kwok
Ph: 410-964-2212
  Glen Burnie
 Tate Cancer Center at Baltimore Washington Medical Center
 Young Kwok
Ph: 410-553-8100
  Olney
 Helen P. Denit Cancer Center at Montgomery General Hospital
 Young Kwok
Ph: 301-260-3700
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 Clinical Trials Office - Beth Israel Deaconess Medical Center
Ph: 617-667-9925
 Boston University Cancer Research Center
 Clinical Trials Office - Boston University Cancer Research Center
Ph: 617-353-7571
 Dana-Farber/Brigham and Women's Cancer Center
 Clinical Trials Office
Ph: 617-724-5200
 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
 William Shipley, MD, FACR
Ph: 617-726-8146
 Massachusetts General Hospital
 Clinical Trials Office - Massachusetts General Hospital
Ph: 877-726-5130
  Fall River
 Hudner Oncology Center at Saint Anne's Hospital - Fall River
 Clinical Trials Office - Hudner Oncology Center at Saint Anne's Hospital - Fall River
Ph: 508-674-5600 ext. 2019
  Framingham
 MetroWest Medical Center - Framingham Union Hospital
 Allison Sacher, MD
Ph: 508-383-1260
  Lowell
 Lowell General Hospital
 William Shipley, MD, FACR
Ph: 617-726-8146
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Clinical Trials Office - University of Michigan Comprehensive Cancer Center
Ph: 800-865-1125
 Veterans Affairs Medical Center - Ann Arbor
 Shruti Jolly
Ph: 734-769-7100
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
 Josephine Ford Cancer Center at Henry Ford Hospital
 Eleanor Walker, MD
Ph: 313-916-1021
  Flint
 Great Lakes Cancer Institute at McLaren Regional Medical Center
 Clinical Trials Office - Great Lakes Cancer Institute at McLaren Regional Medical Center
Ph: 810-342-4071
  Jackson
 Foote Memorial Hospital
 Mary Feng
Ph: 517-788-4800
Minnesota
  Albert Lea
 Albert Lea Cancer Center at Albert Lea Medical Center
 Timothy Kozelsky, MD
Ph: 507-379-2050
  Bemidji
 MeritCare Bemidji
 Preston Steen, MD
Ph: 701-234-2397
  Burnsville
 Fairview Ridges Hospital
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
 Duluth Clinic Cancer Center - Duluth
 Clinical Trials Office - Duluth Clinic Cancer Center - Duluth
Ph: 218-786-3308
 Miller - Dwan Medical Center
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
 St. Luke's Hospital Cancer Care Center
 Steven Bonin
Ph: 218-249-7800
877-249-7800
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Mankato
 Immanuel St. Joseph's
 Ron Smith
Ph: 507-345-2929
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel Anderson
Ph: 651-232-7970
 Minnesota Oncology Hematology, PA - Maplewood
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - River Campus
 Barbi Kaplan-Frenkel, DO
Ph: 320-229-4901
 Coborn Cancer Center
 Barbi Kaplan-Frenkel, DO
Ph: 320-229-4901
  Saint Louis Park
 CCOP - Metro-Minnesota
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
 Park Nicollet Cancer Center
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Saint Paul
 United Hospital
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Waconia
 Ridgeview Medical Center
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Paul Sperduto, MD, MAPP
Ph: 952-442-6000
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Joplin
 St. John's Regional Medical Center
 Clinical Trials Office - St. John's Regional Medical Center
Ph: 417-625-2488 ext. 2949
  Kansas City
 Kansas City Cancer Centers - North
 Vivek Kavadi
Ph: 816-746-4570
 Kansas City Cancer Centers - South
 Vivek Kavadi
Ph: 816-333-1326
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany Sleckman, MD
Ph: 314-251-7057
 David C. Pratt Cancer Center at St. John's Mercy
 Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy
Ph: 314-251-6770
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jeff Michalski, MD
Ph: 314-362-8566
  Saint Peters
 Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
 Jeff Michalski, MD
Ph: 314-362-8566
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
 Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Northern Rockies Radiation Oncology Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Benjamin Marchello, MD
Ph: 406-238-6290
 Big Sky Oncology
 Clinical Trail Office - Big Sky Oncology
Ph: 406-731-8217
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Grant Harrer, MD, FACP, CCTI
Ph: 406-731-8100
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew Huang
Ph: 402-354-5890
877-850-3212
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
  Reno
 Radiation Oncology Associates - Reno
 Jonathan Tay
Ph: 702-823-1990
 Saint Mary's Regional Medical Center
 Jonathan Tay
Ph: 775-770-3194
New Hampshire
  Concord
 Dartmouth - Hitchcock Concord
 Arul Mahadevan
Ph: 603-230-6100
  Exeter
 Center for Cancer Care at Exeter Hospital
 Gary Proulx
Ph: 570-882-4048
  Keene
 Kingsbury Center for Cancer Care at Cheshire Medical Center
 Alan Hartford, MD, PhD
Ph: 603-650-6600
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
 Email: cancerhelp@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Clinical Trial Office - Cancer Institute of New Jersey at Cooper Uniersity Hospital
Ph: 856-325-6757
  Freehold
 CentraState Medical Center
 Henry Tsai
Ph: 732-431-2000
  Jamesburg
 Princeton Radiation Oncology Center
 Douglas Fein
Ph: 609-655-5755
  Marlton
 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
 Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Ph: 888-847-8823
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Newark
 Newark Beth Israel Medical Center
 Clinical Trials Office - Newark Beth Israel Medical Center
Ph: 973-926-3136
  Princeton
 University Medical Center at Princeton
 Douglas Fein
Ph: 609-497-4000
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Adam Dicker, MD, PhD
Ph: 215-955-6527
  Trenton
 Capital Health Regional Cancer Center
 Shirnett Williamson, MD
Ph: 340-775-5433
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Lemuel Ariaratnam, MD
Ph: 609-261-7074
New Mexico
  Albuquerque
 Lovelace Medical Center - Downtown
 Benny Liem, MD
Ph: 505-727-7900
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Albany
 New York Oncology Hematology, PC at Albany Regional Cancer Care
 Vivek Kavadi
Ph: 518-489-2607
  Binghamton
 Lourdes Regional Cancer Center
 Michael Fallon
Ph: 607-798-5230
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey Kirshner, MD
Ph: 315-472-7504
  Ithaca
 Cayuga Medical Center of Ithaca
 David Cho
Ph: 607-274-4011
  Manhasset
 CCOP - North Shore University Hospital
 Louis Potters, MD, FACR
Ph: 516-632-3370
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital
Ph: 516-734-8900
  New Hyde Park
 Long Island Jewish Medical Center
 Louis Potters, MD, FACR
Ph: 516-632-3370
  New York
 NYU Cancer Institute at New York University Medical Center
 Nicholas Sanfilippo
Ph: 212-263-6485
  Poughkeepsie
 Hudson Valley Oncology Associates
 Adam Dicker, MD, PhD
Ph: 215-955-6527
 Saint Francis Hospital Cancer Center
 Michael Gallagher
Ph: 845-483-5959
800-483-5000
  Rochester
 Highland Hospital of Rochester
 Paul Okunieff, MD
Ph: 585-275-5575
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Paul Okunieff, MD
Ph: 585-275-5575
North Carolina
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
  Gastonia
 CaroMont Cancer Center at Gaston Memorial Hospital
 Clinical Trials Office - CaroMont Cancer Center at Gaston Memorial Hospital
Ph: 704-834-2932
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
 Wayne Radiation Oncology
 James Atkins, MD
Ph: 919-580-0000
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
  Fargo
 CCOP - MeritCare Hospital
 Preston Steen, MD
Ph: 701-234-2397
 MeritCare Broadway
 Preston Steen, MD
Ph: 701-234-2397
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Fromm, MD
Ph: 330-344-6448
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 William Demas, MD
Ph: 330-375-3557
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Kevin Redmond, MD
Ph: 513-584-9089
  Cleveland
 Cleveland Clinic Cancer Center at Fairview Hospital
 Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital
Ph: 216-476-9362
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
  Independence
 Cleveland Clinic Cancer Center
 John Suh, MD
Ph: 216-444-5574
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 John Suh, MD
Ph: 216-444-5574
  Salem
 Cancer Care Center, Incorporated
 William Demas, MD
Ph: 330-375-3557
  West Chester
 Precision Radiotherapy at University Pointe
 Kevin Redmond, MD
Ph: 513-584-9089
  Wooster
 Cancer Treatment Center
 Clinical Trials Office - Cancer Treatment Center
Ph: 330-375-4221
 Cleveland Clinic - Wooster
 Clinical Trials Office - Cleveland Clinic - Wooster
Ph: 800-862-7798
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence Herman
Ph: 405-271-6822
Oregon
  Eugene
 Willamette Valley Cancer Center - Eugene
 Vivek Kavadi
Ph: 541-683-5001
  The Dalles
 Celilo Cancer Center at Mid-Columbia Medical Center
 Keith Stelzer, MD, PhD
Ph: 541-296-7204
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital
Ph: 215-481-2402
  Bryn Mawr
 Bryn Mawr Hospital
 Clinical Trials Office - Bryn Mawr Hospital
Ph: 610-645-2680
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Darby
 Mercy Fitzgerald Hospital
 Clinical Trials Office - Mercy Fitzgerald Hospital
Ph: 610-237-4982
  Dunmore
 Northeast Radiation Oncology Center
 Adam Dicker, MD, PhD
Ph: 215-955-6527
  Langhorne
 St. Mary Regional Cancer Center
 Clinical Trials Office - St. Mary Regional Cancer Center
Ph: 215-710-4585
  Milford
 Upper Delaware Valley Cancer Center
 Adam Dicker, MD, PhD
Ph: 215-955-6527
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Clinical Trials Office - Cancer Center of Paoli Memorial Hospital
Ph: 610-648-1637
  Philadelphia
 Albert Einstein Cancer Center
 Kenneth Zeitzer, MD
Ph: 215-456-6280
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
 Fox Chase Cancer Center CCOP Research Base
 Clinical Trials Office - Fox Chase Cancer Center CCOP Research Base
Ph: 215-728-2983
 Frankford Hospital Cancer Center - Torresdale Campus
 Adam Dicker, MD, PhD
Ph: 215-955-6527
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Ph: 215-955-6084
 MNAP Oncologic Center
 Noel Kramer
Ph: 215-673-9260
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Clinical Trials Office - Guthrie Cancer Center at Guthrie Clinic Sayre
Ph: 800-836-0388
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
  Wynnewood
 CCOP - Main Line Health
 Paul Gilman, MD
Ph: 610-645-2000
 Lankenau Cancer Center at Lankenau Hospital
 Paul Gilman, MD
Ph: 610-645-2000
  York
 York Cancer Center at Apple Hill Medical Center
 Amit Shah
Ph: 717-741-8180
South Carolina
  Myrtle Beach
 Carolina Regional Cancer Center
 Todd Williams, MD
Ph: 843-449-9415
  Spartanburg
 CCOP - Upstate Carolina
 Clinical Trials Office - CCOP - Upstate Carolina
Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Clinical Trials Office - Gibbs Regional Cancer Center
Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Eric Eastmo, MD
Ph: 605-719-2360
Texas
  Bedford
 Texas Oncology, PA at Harris Center HEB
 Vivek Kavadi
Ph: 817-359-9000
  Bryan
 St. Joseph Regional Cancer Center
 Scott Goble, MD
Ph: 979-774-0808
  Dallas
 Medical City Dallas Hospital
 Vivek Kavadi
Ph: 972-566-7000
 Texas Oncology, PA at Texas Cancer Center Dallas Southwest
 Vivek Kavadi
Ph: 972-709-2580
  Fort Worth
 Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
 Vivek Kavadi
Ph: 817-820-4820
  San Antonio
 Cancer Therapy and Research Center
 Clinical Trials Office - Cancer Therapy and Research Center
Ph: 210- 616-5798
 University of Texas Health Science Center at San Antonio
 Gregory Swanson, MD
Ph: 210-450-5648
  Sherman
 Texas Oncology, PA at Texas Cancer Center - Sherman
 Vivek Kavadi
Ph: 903-892-9455
  Sugar Land
 Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
 Vivek Kavadi
Ph: 281-277-5200
Utah
  Cedar City
 Sandra L. Maxwell Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Clinical Trials Office - McKay-Dee Hospital Center
Ph: 801 387-7426
  Provo
 Utah Valley Regional Medical Center - Provo
 Clinical Trials Office - Utah Valley Regional Medical Center - Provo
Ph: 801-357-7965
  Saint George
 Dixie Regional Medical Center - East Campus
 Clinical Trials Office - Dixie Regional Medical Center - East Campus
Ph: 435-688-4167
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Clinical Trials Office - Huntsman Cancer Institute at University of Utah
Ph: 801-581-4477
 Email: clinical.trials@hci.utah.edu
 LDS Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
  Rutland
 Community Cancer Center at Rutland Regional Medical Center
 Richard Lovett, MD
Ph: 802-747-1831
  Saint Johnsbury
 Norris Cotton Cancer Center - North
 Alan Hartford, MD, PhD
Ph: 603-650-6600
Virginia
  Alexandria
 INOVA Alexandria Hospital
 Matthew Poggi
Ph: 703-504-3000
  Danville
 Danville Regional Medical Center
 Clinical Trials Office - Danville Regional Medical Center
Ph: 434-799-3753
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Clinical Trials Office - Sentara Cancer Institute at Sentara Norfolk General Hospital
Ph: 757-388-2406
  Portsmouth
 Naval Medical Center - Portsmouth
 Clinical Trials Office - Naval Medical Center - Portsmouth
Ph: 757-953-5939
  Richmond
 Veterans Affairs Medical Center - Richmond
 Clinical Trials Office - Veterans Affairs Medical Center - Richmond
Ph: 804-675-5646
Washington
  Bremerton
 Harrison Medical Center
 Stephen Springate
Ph: 360-792-6605
  Federal Way
 St. Francis Hospital
 Lauren Colman, MD
Ph: 253-403-1677
  Puyallup
 Good Samaritan Cancer Center
 Lauren Colman, MD
Ph: 253-403-1677
  Tacoma
 CCOP - Northwest
 Lauren Colman, MD
Ph: 253-403-1677
 Franciscan Cancer Center at St. Joseph Medical Center
 Clinical Trials Office - Franciscan Cancer Center
Ph: 253-426-6914
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Clinical Trials Office - MultiCare Regional Cancer Center
Ph: 253-403-3229
West Virginia
  Charleston
 West Virginia University Health Sciences Center - Charleston
 Steven Jubelirer, MD
Ph: 304-388-8380
Wisconsin
  Appleton
 Theda Care Cancer Institute
 Clinical Trials Office - Theda Care Cancer Institute
Ph: 920-380-1500
  La Crosse
 Franciscan Skemp Healthcare - La Crosse Campus
 Kernan Minehan, MD
Ph: 608-791-9510
  Menomonee Falls
 Community Memorial Hospital Cancer Care Center
 Colleen Lawton, MD
Ph: 414-805-4472
  Mequon
 Columbia Saint Mary's Hospital - Ozaukee
 Carl Olson, MD
Ph: 414-291-1556
  Milwaukee
 Columbia-Saint Mary's Cancer Care Center
 Clinical Trials Office - Columbia-St. Mary's Cancer Care Center
Ph: 414-326-1739
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth Gore, MD
Ph: 414-805-4465
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James Taylor, MD
Ph: 262-687-5000
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
Canada
British Columbia
  Kelowna
 British Columbia Cancer Agency - Centre for the Southern Interior
 Ross Halperin
Ph: 250-712-3900
  Surrey
 BCCA - Fraser Valley Cancer Centre
 Alexander Agranovich
Ph: 604-930-2098
800-587-2885
  Vancouver
 British Columbia Cancer Agency - Vancouver Cancer Centre
 William Morris
Ph: 604-877-6000
800-663-3333
  Victoria
 British Columbia Cancer Agency - Vancouver Island Centre
 Abraham Alexander
Ph: 250-519-5500
New Brunswick
  Saint John
 Saint John Regional Hospital
 John Carson, MD
Ph: 506-648-6890
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Derek Wilke
Ph: 902-473-6000
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Ian Dayes
Ph: 905-387-9495
  London
 London Regional Cancer Program at London Health Sciences Centre
 Glenn Bauman
Ph: 519-685-8615
  Thunder Bay
 Cancer Care Program at Thunder Bay Regional Health Sciences
 Sunil Premial Gulavita
Ph: 807-684-7200
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Carole Lambert
Ph: 514-281-6000
 McGill Cancer Centre at McGill University
 Sergio Faria
Ph: 514-398-1444
  Quebec City
 Centre Hospitalier Universitaire de Quebec
 Andre-Guy Martin
Ph: 418-525-4444
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Evgeny Sadikov
Ph: 306-766-2203
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Iain MacLennan
Ph: 306-655-2662

Related Information

Featured trial article

Registry Information
Official Title A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients with Favorable-Risk Prostate Cancer
Trial Start Date 2006-04-18
Trial Completion Date 2011-05-18 (estimated)
Registered in ClinicalTrials.gov NCT00331773
Date Submitted to PDQ 2006-04-11
Information Last Verified 2009-11-13
NCI Grant/Contract Number CA21661

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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