NCT01307852

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

March 1, 2011

Last Update Submit

April 4, 2016

Conditions

Prostate Disease

Keywords

Fiber optic radiation detectorsEnhanced endorectal balloonRadiation treatmentRadiotherapyExternal beam radiationDosimetry

Outcome Measures

Primary Outcomes (1)

  • Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy

    Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.

    Twice a week for 7 week treatment.

Study Arms (1)

In Vivo Dosimetry

EXPERIMENTAL

Modified endorectal device capable of real-time dose measurement during prostate radiation therapy

Device: Plastic Scintillation Detectors

Interventions

Plastic Scintillation DetectorsDEVICE

Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment. Treatment delivery Monday through Friday for 7 weeks.

In Vivo Dosimetry

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
  • 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.
  • We will choose patients undergoing photon and proton treatments.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sam Beddar, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 3, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)