NCT01230866

Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Proton Collaborative Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Proton Radiation Hypofractionation	Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
RADIATION	Proton Radiation Standard Fractionation	Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2027-12-01
• First posted: 2010-10-29
• Last updated: 2025-09-04

Locations

5 sites across 1 country: United States