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

Completed · Phase 1/Phase 2

Conditions studied: Clinical Stage T2b or Less of Prostate Cancer, Prostate Brachytherapy, Transrectal Prostate Ultrasound Treatment Planning

In brief

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.

Key facts

Study ID

NCT01227642

Run by

Beth Israel Medical Center

People needed

14

Starts

2007-02-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
• PSA ≤ 10 ng/ml
• Gleason sum on biopsy ≤ 6
• Prostate volume ≤ 50 cc
• Willing to continue follow-up for at least two years.

You may not qualify if…

• No prior hormone therapy
• No prior radiotherapy
• No history of collagen vascular disease
• No history of inflammatory bowel disease

Where it is running

• St.Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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