A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer
- 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.
- 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
- 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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients with change from baseline to the 1-year EPIC bowel-domain score that exceeds 5 points
Pre-treatment to 1 year from the end of protocol treatment
Himu R. Lukka, MD
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Natalie Warren Bryant Cancer Center at St. Francis Hospital||Tulsa, Oklahoma 74136|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Kaiser Permanente Medical Center - Roseville||Roseville, California 95661|
|Kaiser Permanente Medical Center - South San Francisco||South San Francisco, California 94080|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Queen's Cancer Institute at Queen's Medical Center||Honolulu, Hawaii 96813|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Columbia-Saint Mary's Cancer Care Center||Milwaukee, Wisconsin 53211|
|Emory Crawford Long Hospital||Atlanta, Georgia 30308|
|Kaiser Permanente - Division of Research - Oakland||Oakland, California 94611|
|Rohnert Park Cancer Center||Rohnert Park, California 94928|
|Arizona Center for Cancer Care - Peoria||Peoria, Arizona 85381|
|Urology Center of Colorado||Denver, Colorado 80211|
|Fox Chase Cancer Center Buckingham||Furlong, Pennsylvania 18925|
|Academic Urology Prostate Center||King of Prussia, Pennsylvania 19406|
|Rothman Specialty Hospital||Bensalem, Pennsylvania 19020|
|Kaiser Permanente Santa Clara Medical Center||Santa Clara, California 95051|