Radiation Therapy in Treating Patients With Prostate Cancer
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trials Reporting Program)
interventional
255
2 countries
37
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
May 20, 2022
Actual (reported)RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2011
Actual (reported)September 14, 2011
Actual (reported)June 2015
Actual (reported)November 17, 2017
Actual (reported)May 20, 2022
Actual (reported)Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year \> 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
Baseline and one year from the end of protocol treatment
The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points
The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year \> 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
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 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.
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, 85381, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Kaiser Permanente - Division of Research - Oakland
Oakland, California, 94611, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, 95678, United States
UCSF Helen Diller Family Comprehensive Cancer Center
Himu R. Lukka, MD
Margaret and Charles Juravinski Cancer Centre
255 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Baseline and one year from the end of protocol treatment
Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm
Start of protocol treatment to one year from the end of protocol treatment
Rate of PSA Failure
Registration to five years
Rate of Disease-free Survival (DFS)
Registration to 5 years
Mean Quality Adjusted Life Years at 5 Years
Registration to 5 years from the end of protocol treatment
Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year
Baseline and one year from the end of protocol treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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San Francisco, California, 94115, United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, 94080, United States
Urology Center of Colorado
Denver, Colorado, 80211, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Rothman Specialty Hospital
Bensalem, Pennsylvania, 19020, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Academic Urology Prostate Center
King of Prussia, Pennsylvania, 19406, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
Primary Completion
June 2015
Actual (reported)Study Completion
May 20, 2022
Actual (reported)Last Updated
June 9, 2022
Results First Posted
November 17, 2017
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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