MDACC Study Summary 2004-0428

Study Summary
No. 2004-0428:.......Prostate......Andrew K. Lee......Radiation Oncology

Study Summary Title



Study Summary Number:	2004-0428

Study Title:	Evaluation of intraprostatic fiducial markers for targeting of external beam radiation therapy

Physician

New Patient Referral



Name:	Andrew K. Lee	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-5906 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients will return to MDACC as per standard practice at the discretion of the treating radiation oncologist.

Treatment Agents:	Markers Radiation	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to evaluate a system for localizing
(targeting for treatment) the prostate for external beam radiation therapy.
The system will be used to locate the prostate before treatment and to measure
movement of the prostate during treatment. The data collected with the system
will be compared to CT images taken during the course of your radiation therapy
treatment. Researchers will try to use this information to verify the
performance of the system, which could lead to improved positioning and
tracking of the prostate during treatment.

Study Objectives / Outcomes

Primary objective:
1. To collect data on the distribution among patients of the difference in location of the prostate relative to the isocenter as determined by two methods: (1) the minimally invasive, fiducial-based localization system (Acculoc System) for prostate cancer external beam radiotherapy and (2) CT images using a CT-on-rails system.

Secondary objectives:
1. To describe how the difference of the position of the prostate's center of mass (COM) as determined by CT and the mean position of the implanted fiducials (MPIF) changes over time for a group of patients.
2. To collect data and compare the changes in x, y, z treatment couch shifts as determined by the fiducial system and by transabdominal ultrasound of the prostate.

Study Status Information



Study Activation / Registration Date:	09/14/2005

IRB Review and Approval Date:	05/04/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with pathologic diagnosis of prostate cancer.

2) Patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.

3) Patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.

4) Patients must be able to tolerate frequent (e.g. three CT scans per week) CT scanning.

5) Patients must be able to lie flat and still for the duration of the fiducial-based localization and CT scanning sessions.

6) Patients must have anatomy that will allow an adequate pelvic image on portal imaging and CT scanning.

7) If patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.

8) Patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.

9) Patients must understand and sign informed consent.

Exclusion Criteria:

1) Patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.

2) Patients with an estimated prostate volume of less than 20 cc.

3) Patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.

4) Patients who have had previous radiation therapy to the pelvis.

5) Patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).

6) Patients with a body habitus that the CT bore of the CT/Linac treatment machine cannot accomodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).

7) Patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. Patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.

8) Patients with hip prostheses will not be eligible.

Links

Registration Number: NCT00499421
Study Information on Clinical Trials Registry (clinicaltrials.gov)