Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Study summary
This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.
Eligibility
Primary outcome measure(s)
- Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years — Baseline and two years
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. - Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years — Baseline and two years
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. - Percentage of Participants Alive Without Disease (Disease-free Survival [DSF]) — Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Trial sites (293)
| Facility | City | Region | Status |
|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | |
| Lewis and Faye Manderson Cancer Center | Tuscaloosa | Alabama | |
| Arizona Center for Cancer Care - Gilbert | Gilbert | Arizona | |
| Arizona Center for Cancer Care-Peoria | Peoria | Arizona | |
| Arizona Center for Cancer Care - Scottsdale | Scottsdale | Arizona | |
| Arizona Center for Cancer Care-Surprise | Surprise | Arizona | |
| Arizona Oncology Associates-West Orange Grove | Tucson | Arizona | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Kaiser Permanente-Anaheim | Anaheim | California | |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | |
| Mercy Cancer Center - Carmichael | Carmichael | California | |
| Mercy San Juan Medical Center | Carmichael | California | |
| Kaiser Permanente Dublin | Dublin | California | |
| Mercy Cancer Center - Elk Grove | Elk Grove | California | |
| Fresno Cancer Center | Fresno | California | |
| Marin General Hospital | Greenbrae | California | |
| UC San Diego Moores Cancer Center | La Jolla | California | |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | |
| Los Angeles General Medical Center | Los Angeles | California | |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | |
| Memorial Medical Center | Modesto | California | |
| Kaiser Permanente Oakland-Broadway | Oakland | California | |
| Saint Joseph Hospital - Orange | Orange | California | |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | |
| Mercy Cancer Center - Rocklin | Rocklin | California | |
| Rohnert Park Cancer Center | Rohnert Park | California | |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | |
| Mercy Cancer Center - Sacramento | Sacramento | California | |
| Sutter Medical Center Sacramento | Sacramento | California | |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | |
| Salinas Valley Memorial | Salinas | California | |
| Stanford Cancer Center South Bay | San Jose | California | |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | |
| Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | |
| Woodland Memorial Hospital | Woodland | California | |
| UCHealth University of Colorado Hospital | Aurora | Colorado | |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | |
| Memorial Hospital North | Colorado Springs | Colorado |
+ 253 more sites — see the full list on the official registry below.
More NRG Oncology trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03367702 on ClinicalTrials.gov ↗ ← All trials in India