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Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Brachytherapy implant procedure lasting 1-2 hours.

Brachytherapy

Questionnaire

Steven J. Frank, MD

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.

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. This may include a digital rectal exam if your doctor feels that it is needed. 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.

Brachytherapy for Prostatic Carcinoma Patients

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

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Necrosis

Body Weight

Calcinosis

Disease Susceptibility

Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients.

15 patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies will be enrolled after obtaining informed consent. 15 patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification will serve as a comparison group after providing informed consent for a total of 30 patients.

Imaging

Nick Schieda, MD

Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation.

High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI.

Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.

High grade (Gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcifications in areas of Gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.

Imaging of High Grade Prostate Cancer

Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging

Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.

Two radiologists will review the MRI and CT examinations separated by a 4 week interval to compare other MRI features and clinical factors between Gleason pattern 5 tumors with and without malignant calcification.

Ottawa Hospital Research Institute

Aliaa B Ahmed

Aliaa Bakr

Prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. It is a common health problem. Most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. Diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy.

Six transmembrane epithelial antigen of the prostate 1 (STEAP-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. In prostate, the expression of STEAP-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples.

The antibody designated as p40 recognizes exclusively ΔNp63 and not TAp63. In prostate tissues, it has been shown that p40, the ΔNp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. Furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63.

In this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both STEAP-1 and p 40. Also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.

Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers

Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers: An Immunohistochemical Study

Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brachytherapy for Prostatic Carcinoma Patients	NCT00525720	Prostate Cancer	Brachytherapy Questionnaire	18 Years -	M.D. Anderson Cancer Center
Brachytherapy for Prostatic Carcinoma Patients	NCT00525720	Prostate Cancer	Brachytherapy Questionnaire	18 Years -	M.D. Anderson Cancer Center
Imaging of High Grade Prostate Cancer	NCT02177526	Prostatic Carci...	Imaging	-	Ottawa Hospital Research Institute
Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers	NCT05428319	Prostatic Carci...		-	Sohag University

Spots Global Cancer Trial Database for prostatic carcinoma