CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who Are Undergoing Radiation Therapy

January 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

The Use Of Multiple CT Scans To Reduce Target Positioning Errors In Patients Undergoing External Beam Radiotherapy Treatment For Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans may improve the accuracy of radiation therapy for prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the accuracy of radiotherapy delivery using multiple CT scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy.
  • Determine the reduction in the proportion of patients with large target positioning errors using the CT-guided procedure.
  • Determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients.

OUTLINE: Patients undergo radiotherapy over 9 weeks. Patients undergo a CT scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. On 3 different days, patients also undergo CT scan immediately after radiotherapy. If the CT scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Undergoing external beam intensity-modulated radiotherapy for prostate cancer
  • Able to maintain treatment position for about 40 minutes

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Treatment accuracy

Secondary Outcome Measures

Outcome Measure
Reduction in the proportion of patients with large target positioning errors using CT guided procedure
Organ motion and setup errors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Lovelock, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-022
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-01022
  • NCI-G01-1968

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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