Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy

Summary

In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.

Conditions

• Clinical Stage T2b or Less of Prostate Cancer
• Prostate Brachytherapy
• Transrectal Prostate Ultrasound Treatment Planning

Interventions

OTHER

An ultrasound-based technique to identify prostate cancer

The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.

OTHER

pre-implant transrectal ultrasound images and planning

an ultrasound-based technique to identify cancer-containing areas within the prostate.

OTHER

ultrasound-based cancer-specific images

ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning

Sponsors & Collaborators

• Riverside Research Institute

  collaborator OTHER

• Beth Israel Medical Center

  lead OTHER

Principal Investigators

• Ronald Ennis, MD · St. Luke's-Roosevelt Hospital Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• United States

Study Locations