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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00331773
First received: May 30, 2006
Last updated: February 28, 2017
Last verified: February 2017
  Purpose

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.


Condition Intervention Phase
Prostate Cancer Radiation: Conventional 3D-CRT or IMRT Radiation: Hypofractionated 3D-CRT or IMRT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Five-year Disease-free Survival (DFS) Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ]
    Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.


Secondary Outcome Measures:
  • Five-year Local Progression Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ]
    Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.

  • Five-year Disease-specific Survival Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

    An event was death in association with any of the following conditions:

    • Primary cause of death certified as due to prostate cancer
    • Further clinical tumor progression occurring after initiation of "salvage" anti-tumor (e.g., (androgen suppression) therapy
    • A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after "salvage" androgen suppression therapy
    • Disease progression in the absence of any anti-tumor therapy
    • Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events.

  • Five-year PSA Failure Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ]
    Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint "Freedom from biochemical recurrence", it defines the endpoint as "The time to PSA failure". An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/dl. Time to biochemical failure was measured from study entry until the date of failure.

  • Five-year Overall Survival Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ]
    Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up

  • Frequency of Patients With GU and GI Acute and Late Toxicity [ Time Frame: Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis. ]
    The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.

  • Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ]
    Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.

  • The Utilization of Sexual Medications/Devices Questionaire [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ]
    The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of "Yes" responses to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?".

  • Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 [ Time Frame: Baseline, 6 months, 12 months, 24 months, and 5 years ]
    Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.

  • EQ-5D Scores [ Time Frame: Baseline, 6 months, 12 months, 24 months, and 5 years ]
    The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 ―Worst health stat and 1 ―Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.

  • Assessment of Trade-off Between Disease-free Survival and Quality of Life. [ Time Frame: From baseline to 5 years from the start of treatment ]
    To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou's multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D. This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.

  • Statistical Modeling of Genomic Biomarkers [ Time Frame: Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis. ]
    Biomarker data has not been obtained yet therefore this analysis has not occurred.


Other Outcome Measures:
  • Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses [ Time Frame: From baseline to 5 years from the start of treatment. ]

Enrollment: 1115
Study Start Date: April 2006
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional 3D-CRT
Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions
Radiation: Conventional 3D-CRT or IMRT
Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Other Names:
  • 3-dimensional conformal radiation therapy
  • Intensity-modulated radiation therapy (IMRT)
Experimental: Hypofractionated 3D-CRT
Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions
Radiation: Hypofractionated 3D-CRT or IMRT
Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Other Names:
  • Hypofractionated 3-dimensional conformal radiation therapy
  • Intensity-modulated radiation therapy (IMRT)

Detailed Description:

OBJECTIVES:

Primary

  • 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

  • Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
  • Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
  • 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.
  • 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 .
  • 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.
  • 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.

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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

    • PSA evaluated at least 10 days after prostate biopsy
    • For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
    • For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
  • No regional lymph node involvement
  • No distant metastases

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331773

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Peninsula Medical Center
Burlingame, California, United States, 94010
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546
Valley Medical Oncology
Fremont, California, United States, 94538
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States, 94545
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588
Kaiser Permanente Medical Center - Rancho Cordova
Rancho Cardova, California, United States, 95670
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States, 94801
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Mercy General Hospital
Sacramento, California, United States, 95819
South Sacramento Cancer Center
Sacramento, California, United States, 95823
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States, 95823
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States, 94115
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States, 95119
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States, 95210
General Robert Huyser Cancer Center at David Grant Medical Center
Travis AFB, California, United States, 94535-1800
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
Sutter Solano Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
St. Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Bay Medical
Panama City, Florida, United States, 32401
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61615-7827
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States, 46219
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40292
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Helen P. Denit Cancer Center at Montgomery General Hospital
Olney, Maryland, United States, 20832
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
MetroWest Medical Center - Framingham Union Hospital
Framingham, Massachusetts, United States, 01702
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
United States, Minnesota
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea, Minnesota, United States, 56007
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
Saint Peters, Missouri, United States, 63376
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
Radiation Oncology Associates - Reno
Reno, Nevada, United States, 89509
United States, New Hampshire
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States, 03301
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Princeton Radiation Oncology Center
Jamesburg, New Jersey, United States, 08831
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540-3298
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Capital Health Regional Cancer Center
Trenton, New Jersey, United States, 08618
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Cayuga Medical Center of Ithaca
Ithaca, New York, United States, 14850
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States, 12601
Saint Francis Hospital Cancer Center
Poughkeepsie, New York, United States, 12601
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28053
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Broadway
Fargo, North Dakota, United States, 58122
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Celilo Cancer Center at Mid-Columbia Medical Center
The Dalles, Oregon, United States, 97058
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, United States, 18337
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
MNAP Oncologic Center
Philadelphia, Pennsylvania, United States, 19115
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, South Carolina
Carolina Regional Cancer Center
Myrtle Beach, South Carolina, United States, 29577
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States, 76022
St. Joseph Regional Cancer Center
Bryan, Texas, United States, 77802
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, United States, 75237
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
United States, Utah
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
INOVA Alexandria Hospital
Alexandria, Virginia, United States, 22304
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
United States, Washington
Harrison Medical Center
Bremerton, Washington, United States, 98310
St. Francis Hospital
Federal Way, Washington, United States, 98003
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
CCOP - Northwest
Tacoma, Washington, United States, 98405
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States, 54601
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: W. Robert Lee, MD, MS Duke Cancer Institute
Study Chair: Mahul B Amin, MD Cedars-Sinai Medical Center
Study Chair: Deborah W Bruner, RN, PhD University of Pennsylvania
Study Chair: Daniel Low, PhD Washington University School of Medicine
Study Chair: Gregory P Swanson, MD UTHSC San Antonio
  More Information

Publications:
McDonald AM, Dobelbower MC, Kim RY, et al.: Efficacy and rectal toxicity of hypofractionated radiation therapy with daily image guidance. [Abstract] J Clin Oncol 29 (Suppl 7): A-85, 2011.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00331773     History of Changes
Other Study ID Numbers: RTOG-0415
CDR0000481119
NCI-2009-00721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: May 30, 2006
Results First Received: November 29, 2016
Last Updated: February 28, 2017

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 21, 2017