Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
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|ClinicalTrials.gov Identifier: NCT01288534|
Recruitment Status : Completed
First Posted : February 2, 2011
Results First Posted : June 9, 2016
Last Update Posted : October 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
|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.
- Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL) [ Time Frame: 24 months ]
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 at 12 Months [ Time Frame: 1 Year ]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 ]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 ]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 ]To assess the frequency of required interventions (interruptions) 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. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288534
|United States, California|
|The Radiological Associates of Sacremento|
|Sacramento, 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|