NCT01288534

Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy. The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2011-02-02
• Last updated: 2017-10-24
• Results posted: 2016-06-09

Locations

2 sites across 1 country: United States