Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT01434290
Last Updated: 2022-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2011-09-30
2022-05-20
Brief Summary
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PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
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Detailed Description
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Primary
* To demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Secondary
* To estimate the degree of change in HRQOL in each arm for the Sexual and Hormonal EPIC domains and the Utilization of Sexual Medications/Devices from baseline to 1 year, 2 years, and 5 years.
* To estimate the degree of change in global HRQOL in each arm as measured by the Euro Quality of Life, 5 dimensions (EQ-5D) from baseline to 1 year, 2 years, and 5 years.
* To estimate the rate of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity for each arm at 1, 2, and 5 years.
* To estimate prostate-specific antigen (PSA) failure in each arm at 1, 2, and 5 years.
* To estimate disease-free survival (DFS) in each arm at 1, 2, and 5 years.
* To estimate Quality Adjusted Life Years for each arm at 1, 2, and 5 years using the EQ-5D and DFS.
* To identify genetic markers associated with normal tissue toxicities resulting from radiotherapy.
* To collect tumor tissue for biomarker studies.
* To estimate EPIC bowel and urinary HRQOL as continuous variables.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment techniques/machine (all linear accelerator-based treatment \[excluding cyberknife\] vs cyberknife vs protons). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo hypofractionated radiotherapy using intensity-modulated radiation therapy (IMRT), cyberknife, or protons twice a week for approximately 2½ weeks (36.25 Gy total).
* Arm II: Patients undergo hypofractionated radiotherapy using IMRT, cyberknife, or protons once a day, 5 days a week, for approximately 2½ weeks (51.6 Gy total).
Patients may undergo blood and tumor tissue collection for correlative studies.
Patients may also complete the Utilization of Sexual Medications/Devices, the European Questionnaire-5D, and the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) questionnaires at baseline and at 1, 2, and 5 years after completion of radiation therapy.
After completion of study therapy, patients are followed-up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5 Fractions
36.25 Gy IMRT in 5 fractions over two and a half weeks
36.25 Gy IMRT
36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.
12 Fractions
51.6 Gy IMRT in 12 fractions over two and a half weeks
51.6 Gy IMRT
51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.
Interventions
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36.25 Gy IMRT
36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.
51.6 Gy IMRT
51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.
Eligibility Criteria
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Inclusion Criteria
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Himu R. Lukka, MD
Role: PRINCIPAL_INVESTIGATOR
Margaret and Charles Juravinski Cancer Centre
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Urology Center of Colorado
Denver, Colorado, United States
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Rothman Specialty Hospital
Bensalem, Pennsylvania, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States
Academic Urology Prostate Center
King of Prussia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CDR0000703580
Identifier Type: -
Identifier Source: secondary_id
NCI-2011-03629
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG 0938
Identifier Type: -
Identifier Source: org_study_id
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