Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion|
- Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.
Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months.
- Percentage of Patients With a PSA Nadir of <3.35 ng/ml [ Time Frame: 1 Year ] [ Designated as safety issue: No ]To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.
- Relation Between Dose Distribution and Toxicities. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.
- Relation Between Reconstructed Delivered Dose Distributions. [ Time Frame: 5 years ] [ Designated as safety issue: No ]To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
- Frequency of Required Interventions. [ Time Frame: 5 years ] [ Designated as safety issue: No ]To assess the frequency of required interventions based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical.
|Study Start Date:||January 2011|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Experimental: Radiation Treatment||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288534
|United States, California|
|The Radiological Associates of Sacremento|
|Sacremento, California, United States, 95815|
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States|
|Principal Investigator:||Daniel Spratt, MD||University of Michigan Cancer Center|