This trial is active, not recruiting.

Condition prostate disease
Treatment plastic scintillation detectors
Phase phase 1
Sponsor M.D. Anderson Cancer Center
Start date November 2011
End date April 2016
Trial size 15 participants
Trial identifier NCT01307852, 2010-0427, NCI-2011-00863


The goal of this clinical research study is to learn if a rectal balloon with attached radiation detectors can be used to help researchers monitor the dose of external beam radiation that is delivered to the prostate during treatment. This may help researchers better understand the side effects of radiation therapy, such as rectal bleeding, and may lead to changes in treatment planning or treatment delivery.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Modified endorectal device capable of real-time dose measurement during prostate radiation therapy
plastic scintillation detectors
Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment. Treatment delivery Monday through Friday for 7 weeks.

Primary Outcomes

Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy
time frame: Twice a week for 7 week treatment.

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients. 2. The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study. 3. We will choose patients undergoing photon and proton treatments. Exclusion Criteria: N/A

Additional Information

Official title Pilot Study to Evaluate In Vivo Plastic Scintillation Detectors for Real-Time Radiation Dosimetry During Prostate Cancer Radiotherapy
Principal investigator Sam Beddar, PHD
Description As a part of your standard of care, you will have external beam radiation therapy. You will have a computerized tomography (CT) scan of the pelvis before the external beam radiation therapy. For the CT scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder A rectal balloon will then be inserted into your rectum and filled with either air or water. You will then have the CT scan. The CT scan should take about 45 minutes. If you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two CT scans per week you will have while you are receiving radiation. You may have additional CT scans (without the detector) each week if your doctor thinks it is needed. The doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study. You will be off study after your final radiation treatment using the rectal balloon. This is an investigational study. Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.