Trial Information

Transperineal Interstitial Permanent Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive
pellets) into your prostate in order to treat the prostate cancer with radiation therapy.

If you are found to be eligible to take part in this study, you will have an ultrasound of
your prostate before brachytherapy so that the prostate can be measured and mapped and the
placement of the needles and seeds planned ahead of time. This is a 20-minute outpatient
procedure that involves placing a probe (tube) into your rectum, which takes ultrasound
pictures of the prostate to learn the size and shape. A specialized radiation plan for each
patient is made, and the exact number of needles and seeds depend on the size and shape of
the prostate. Ultrasound pictures, using the probe in the rectum, are taken before the
implant procedure so that the plan can be made.

Brachytherapy is an outpatient surgical procedure. Under general or spinal anesthesia, you
will have thin needles inserted through the skin between the anus and the scrotum. Seeds
are inserted into the prostate through the needles. An ultrasound probe (tube which sends
images of the prostate to a screen) is placed into the rectum and remains there during the
procedure to help direct the needles. After the seeds are inserted, the needles are
removed. The seeds remain permanently in the prostate. Typically, about 25 needles are
inserted with about 100 seeds. The implant procedure takes about 1-2 hours in the operating
room. Afterwards, you will go to the recovery room for 1-3 hours. You will then have a
computed tomography (CT) scan after the procedure to make sure the seeds are properly
placed. You will then be allowed to return home.

After treatment, you will have a study visit in 4-6 weeks. After that first follow-up visit,
you will have follow-up visits at 4, 8, and 12 months (+/- 3 weeks) after treatment. After
that, follow-up visits are every 6 months until 5 years after treatment and then once a year
from then on (+/- 3 weeks). At these visits, you will have a physical exam, including a
digital rectal exam. Blood (about 3 teaspoons) will be drawn for routine tests. You will be
asked to complete 2 questionnaires about your urinary, bowel, sexual function, and overall
quality of life. The 2 questionnaires take about 30 minutes to complete in total. A CT scan
of the prostate will also be performed at the first follow-up visit after the implant to
make sure the seeds are properly placed.

If blood tests show that your cancer is getting worse, a biopsy may be done after the
treatment is complete. A biopsy is done by inserting a needle through the rectum and into
the prostate. The procedure is similar to the one done to first diagnose your prostate
cancer. Six (6) to 10 samples are usually taken. The doctor will also perform an
ultrasound. This is done by placing a tube in the rectum, which shows a picture of the
prostate on a screen and is used to guide the biopsies.

You will be taken off study if your disease progresses. Otherwise, you will remain on study
indefinitely.

This is an investigational study. Brachytherapy is FDA approved. Up to 300 patients will
take part in this study. All will be enrolled at MD Anderson.