Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients with High Risk Prostate Cancer

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT05946213
Trial Phases:	Phase III	Protocol IDs:	NRG-GU013 (primary) NRG-GU013 NCI-2023-04142
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05946213

Summary

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Objectives

PRIMARY OBJECTIVE:
I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation.

SECONDARY OBJECTIVES:
I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms.
II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains).
III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain).
IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms.
V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms.
VI. To compare failure-free survival between treatment arms.
VII. To compare metastasis-free survival based on molecular imaging between treatment arms.
VIII. To compare overall survival between treatment arms.

EXPLORATORY OBJECTIVES:
I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms.
II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.

ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks. Patients also undergo CT and/or MRI on study.

Patients are followed up every 6 months for 5 years.

Treatment Sites in Georgia

Emory Proton Therapy Center
615 Peachtree Street NE
Atlanta, GA 30308
winshipcancer.emory.edu/proton-therapy-center/

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.