NRG-GU005
Closed to Accrual & Treatment
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Principal Investigator
Rodney J. Ellis
Status
Closed to Accrual & Treatment
Open to Accrual
November 16, 2017
Closed to Accrual
June 8, 2022
Closed to Accrual & Treatment
July 17, 2022
Disease Site
Genitourinary [GU] Prostate
Phase
III
Developmental Therapeutics
No
Primary Objective
- To determine whether SBRT can be shown to be superior to hypofractionated IMRT in terms of GU and GI toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel HRQOL as measured by EPIC-26 at 24 months post completion of therapy.
- To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy) as measured by Disease Free Survival (DFS)
Patient Population
Patients with previously untreated localized intermediate-risk prostate cancer
Target Accrual
622
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Patient Study Webpage
To learn more about this study, visit the Patient Study Webpage.
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