HALO DIAGNOSTICS' PROSTATE CANCER PROGRAM
We use multiparametric magnetic resonance imaging (mpMRI) for the detection and localization of prostate cancer for men with abnormal PSA levels. A diagnostic mpMRI creates a detailed cross-sectional image of the prostate gland without an invasive procedure. HALO Diagnostics’ Board Certified Radiologists then examine the images using Computer Aided Detection to identify areas in the gland that look suspicious. These areas may be further evaluated through a targeted MR-guided biopsy. Finally, we offer Laser Focal Therapy as a treatment option for men with early stage (localized) prostate cancer and for men with biochemical recurrence. Laser focal therapy performed by the team at HALO Diagnostics, has a lower risk of side effects such as urinary incontinence, impotence and decreased bowel function compared to surgery or radiation therapy.
MAGNETIC RESONANCE IMAGING OF THE PROSTATE GLAND
Multi-parametric MRI (mpMRI) is a powerful tool used to identify areas of the prostate that might be suspicious for clinically significant cancer. We use state of the art MRI scanning technology to provide the best possible image of the prostate to help improve diagnosis and to reduce the number of biopsies that may be required. The high spatial and temporal resolution of MRI lends itself well to imaging the prostate gland. In other words, mpMRI provides a more holistic view of the prostate compared with more traditional approaches.
While only a biopsy can diagnose cancer, mpMRI imaging with a multi-parametric approach can assist with the characterization of areas within the gland that may warrant biopsy. Given the utility of mpMRI, the AUA recommends an MRI for men with abnormal PSA and BEFORE biopsy.
Learn More About the AUA Policy Statement:
MULTIPARAMETRIC MRI GUIDED BIOPSY IS SUPERIOR TO ULTRASOUND APPROACH
If a suspicious area is found on the multi-parametric MRI scan, we can perform an MRI-guided biopsy that is targeted to the suspicious area. A targeted MRI-guided biopsy provides greater accuracy in diagnosis with fewer needle cores than traditional ultrasound guided approach, resulting in less pain and a lower risk of infection.
Multiparametric MRI guided biopsy advantages over transrectal ultrasound guided biopsy (TRUS Biopsy):
Lower risk of pain and infection.
Find more clinically significant cancers.
Find fewer clinically insignificant cancers.
Reduce the total number of biopsies required.
Contact us to learn more about MRI-guided biopsy.
LASER FOCAL THERAPY FOR PROSTATE CANCER
In 2010, the team of Bernadette Greenwood, Chief Research Officer at Halo Diagnostics, and Roger McNichols, PhD developed a unique prostate biopsy system to perform Laser Interstitial Thermal Therapy or Laser Focal Therapy. The first case in the world was performed by the HALO Diagnostics team of Dr. John Feller, Dr. McNichols and Ms. Greenwood in 2010.
Prostate cancer is commonly managed with radical prostatectomy (RP) or radiation therapy (RT). Between 20-40% of men undergoing RP experience biochemical recurrence (BCR) before 10 years. 30-50% or those receiving radical prostatectomy experience biochemical recurrence. Treatment options for these men are limited and include: salvage radiation, close surveillance, androgen deprivation therapy (ADT), or participation in a clinical trial. Our IRB-approved study evaluates the use of transrectally delivered, MR-guided laser focal therapy.
This procedure involves placing the patient inside the MRI scanner and displaying MRI images and thermal maps on a computer screen. A thin laser fiber is guided to the tumor and laser energy is applied to heat, coagulate and kill the cancer cells. The temperature and the extent of the ablation zone are constantly monitored with MR imaging. The result is the elimination of MRI-visible cancer with very low risk of side effects and a number of benefits, including:
Minimally invasive, ambulatory outpatient procedure.
Rapid recovery and most patients can return to work the next day.*
No general anesthesia required.
Lower risk of side effects such as urinary incontinence, impotence and decreased bowel function compared to surgery or radiation therapy.
With focal laser therapy, we contour our approach to the areas of the prostate that need to be treated, while creating safety boundaries around the areas we do not want to hurt.
Better accuracy compared with other focal approaches, e.g. High-Intensity Focused Ultrasound (HIFU).
Unlike other treatments, focal laser therapy does not limit the option to treat with radiation therapy or surgery if needed later.
Vast majority of men have improved urination after the procedure.*
*Results may vary
IRB Approved at the Study Level
May 19, 2020
PROSTATE CANCER CLINICAL TRIAL
Prostate Cancer Clinical Trial for Prostate Ablation in Patients with Localized Prostate Cancer
The purpose of this study is to obtain information on the effectiveness of transrectal delivered MRI guided Laser Focal Therapy. The system is designed to destroy prostate tissue under Magnetic Resonance Imaging (MRI) guidance using laser energy.
WHAT IS A CLINICAL STUDY?
A clinical study is a type of research study. Study staff will explain the clinical trial to you. Clinical trials include only people who choose to take part. If you have any questions, you can ask study staff for more explanation or visit:
HOW OFTEN WILL I BE SEEN?
After the procedure, you will have an ultrasound of your bladder after 48 hours. After that your follow-up visits will be at 6 months and 1 year. PSA testing and surveys will be done at 3 months, 2 years, 3 years and annually for 20 years. This protocol is to track and study rates of biochemical recurrence and metastasis.
WHAT IS THE PROCEDURE?
The laser focal therapy procedure (also called LITT or FLA) is designed to destroy prostate tissue under Magnetic Resonance Imaging (MRI) guidance using laser energy. The laser device is FDA 510(k) cleared for clinical use for soft tissue necrotization. The planning system is FDA 510(k) cleared for MRI guided prostate biopsy. DMI is the first site in the world to combine the devices under IRB approved clinical trial NCT 02243033.
ARE THERE ANY RISKS?
As with many procedures, there are some risks associated with laser focal therapy which can include: pain, bleeding, infection, decrease in seminal fluid volume, incontinence and erectile dysfunction. Study staff will review all the risks associated with the procedure with you and address any questions or concerns.
WHO CAN JOIN THIS STUDY
You can take part in this study of follow up if you are age 45 or older and have been diagnosed with prostate cancer that is low to intermediate risk and is confined to your prostate gland or have recurrent prostate cancer. There are also additional criteria for participating in this study. Study staff will review the full list with you. Approximately 1000 men will participate in this study.
Assessing Prostate Cancer with Multiparametric MRI
Multiparametric MRI can help detect prostate abnormalities in men with elevated serum PSA.
Targeted Biopsy is More Accurate
Multiparametric MRI can help improve detection of clinically relevant prostate cancer and help inform the most effective treatment options.
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FREQUENTLY ASKED QUESTIONS
HOW DO I DECIDE IF MPMRI IS A GOOD OPTION FOR ME?
Multiparametric Magnetic Resonance Imaging can be considered when/for:
Clinical suspicion of prostate cancer, including prostate-specific antigen (PSA) levels in the blood >4 ng/ml, abnormal digital rectal exam, and no prior history of prostate biopsy.
Active surveillance in men diagnosed with lower risk prostate cancer.
Managing prostate cancer in patients post-treatment. Monitoring patients with biochemical recurrence of prostate cancer following treatment (prostatectomy or radiation).
WHAT ARE THE ADVANTAGES OF IMAGING-GUIDED BIOPSY OVER CONVENTIONAL TRUS BIOPSY?
Imaging-guided biopsy has the following advantages
The MRI-guided biopsy is specific targeting of tumor suspicious region instead of random sampling (TRUS biopsy can miss aggressive cancer lesions about 30-35% of the time)
Minimally invasive with fewer cores (3-4) instead of 12 core TRUS Bx
Reduced chances of infection
Increased sensitivity of detecting aggressive lesions with decreased potential for detecting indolent disease. This reduces overtreatment and prevents the psychological burden with misclassification of cancer stage
WHAT SHOULD I EXPECT BEFORE THE (MR-GUIDED) BIOPSY PROCEDURE?
Most patients visiting the clinic are concerned about the actual procedure and what it entails.
At DMI we believe in providing care with advanced technology.
Patients can request a consultation with one of our expert clinicians to address questions and uncertainties around the procedure.
Prior to the procedure, they are also provided an informed consent form that details the risks and benefits.
Patients are recommended to discontinue anticoagulants at least five days before the biopsy.
Antibiotics are administered during the biopsy to avoid any infection or inflammation. We use numbing jelly to make sure the patients have an overall comfortable experience.
WHAT IS GLEASON SCORE?
Gleason score is an indicator of prostate cancer condition - higher scores mean more aggressive cellular architecture (think of golf scores!).
It is the sum of two numbers, Primary Gleason Grade and Secondary Gleason Grade, ranging from 1-5 that indicate the pathology of the cells in the tumor. A lower number indicates that the biopsy is closer to normal tissue and vice versa.
The Gleason Scores (sum of Grades) range between 6-10 and describe the aggressiveness of the disease. Higher scores (8 and above) predict that cancers might grow and/or spread quickly. A Gleason score 7 (4+3/ 3+4) suggests intermediate risk with 4+3 being at a higher risk of progression than 3+4 (as the 4 pattern is dominant).
The same biopsy tissue can be used to for genomic testing to assess the unique tumor biology of each patient to help guide treatment decisions.
DO YOU OFFER FREE HEALTH CONSULTATIONS?
Yes, our health experts are available to provide free consultation and answer your questions prior to the procedures. Contact our experts TODAY!