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Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

NCT01581749 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-03-23

No results posted yet for this study

Summary

The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

Conditions

  • Prostate Neoplasms

Interventions

RADIATION

"TrueBeam" stereotactic body radiosurgery

36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

Sponsors & Collaborators

  • Albert DeNittis

    lead OTHER

Principal Investigators

  • Albert DeNittis, MD · Lankenau Medical Center, Main Line Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581749 on ClinicalTrials.gov