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The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer

Short Title: NRG-GU013

Enrollment Status: Recruiting

NCT #: NCT05946213

Specialty Area: Oncology

Condition Studied: High-Risk Prostate Adenocarcinoma

Age Groups: Adult; Older Adult

Phase: III

Study Information

Summary / Purpose

The purpose of this study is to compare two radiation treatment schedules for high-risk prostate cancer: one delivers a higher dose of radiation per treatment for fewer treatments over a shorter length of time (SBRT); the other delivers a lower dose of radiation per treatment but for more treatments over a longer time.

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adult males 18+ years of age
Confirmed diagnosis of adenocarcinoma of prostate cancer
Evidence of high-risk disease
No metastatic disease outside of the pelvic nodes
No prior radiotherapy to the impacted region

What's Involved

Participation in the study will include:

Random assignment to one of two radiation schedules: a shorter course of 5 treatments over 2 weeks, or the usual course of 20 to 45 treatments over 4 to 9 weeks
A magnetic resonance imaging (MRI) scan of the prostate to plan your radiation treatment
Imaging scans with computed tomography (CT), MRI, positron emission tomography (PET), and bone scans
Blood sample collection
Completing questionnaires about your urinary, bowel, and sexual function, your energy levels, and your quality of life

Principal Investigator

Suchit Patel, MD, PhD

Radiation Oncology

(775) 982–5638

William N. Pennington Cancer Institute

View Provider

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT05946213

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.