Brachytherapy for Prostatic Carcinoma Patients
The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied.
1. The primary goal of this study is to evaluate interstitial brachytherapy alone as related to biochemical (PSA) progression.
- The secondary endpoints are to evaluate interstitial brachytherapy alone as related to: (a) overall survival, (b) disease-free survival, (c) disease-specific survival, (d) local progression, and (e) distant metastases.
- To evaluate morbidity/quality of life with interstitial brachytherapy alone.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transperineal Interstitial Permanent Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma|
- Biochemical prostate specific antigen (PSA) progression [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.
Brachytherapy implant procedure lasting 1-2 hours.Behavioral: Questionnaire
Questionnaires taking 30 total minutes.
Other Name: Survey
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.
|Contact: Steven J. Frank, MD||713-563-2300|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Steven J. Frank, MD|
|Principal Investigator:||Steven J. Frank, MD||M.D. Anderson Cancer Center|