CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Radiation Therapyradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01288534
NCT01288534Phase 2Completed

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

University of Michigan Rogel Cancer Center·interventional·Posted Feb 2, 2011·Updated Oct 24, 2017

In Brief

A Phase 2 clinical trial evaluating Radiation Therapy for Prostate Cancer. Completed, enrolled 68 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.4 years ago

Interventions

Radiation Therapyradiation

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.