PROSTATE CANCER CLINICAL TRIAL DETAILS
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: www.clinicaltrials.gov
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.
MEET OUR TEAM
Chief Medical Officer, HALO Diagnostics
Dr. John F. Feller is a founding partner of Desert Medical Imaging and currently the Chief Medical Officer for HALO Diagnostics. Dr. Feller board-certified as a Diagnostic Radiologist with sub-specialties in Orthopedic & Sports Medicine Imaging, Body MRI, and holds a Level II Cardiac CT certification. After completing a Bachelor’s degree in Metallurgical Engineering and Material Science at the University of Notre Dame, Dr. Feller graduated Summa Cum Laude from Ohio State University School of Medicine, then an internship, residency, and fellowship training at Stanford University School of Medicine. Serving as a United States Air Force (USAF) officer, Dr. Feller was the Chief of MRI at the David Grant USAF Medical Center for four years, while maintaining an academic affiliation with Stanford as an Assistant Clinical Professor in the Department of Radiology, an affiliation that lasted 15 years. Dr. Feller has co-authored many peer-reviewed journal articles and served as editor for the textbook Shoulder Magnetic Resonance Imaging. He has been invited to over 300 lectures on the subjects of orthopedic imaging, prostate cancer imaging, and body MR imaging.
Chief Research Officer, HALO Diagnostics
In her current capacity as Chief Research Officer at HALO Diagnostics, Ms. Bernadette Greenwood oversees clinical and research activities. She lectures frequently on topics related to oncologic imaging and is an internationally recognized expert in prostate MRI and MR-guided intervention. Ms. Greenwood is currently pursuing her PhD and was awarded the Army Women's Leadership Foundation Legacy Graduate Scholarship. She was also named Research Advocacy Network Scholar 2015. She has published multiple journal articles and textbook chapters on prostate imaging and intervention and is a member of the RSNA, AUA, ASCO, AACR and ESMRMB. She also serves on the AdMeTech International Working Group for Prostate MRI as well as ACR Prostate Site Designation Committee. In 2014, she founded the International Laser Network to bring together international experts on laser focal therapy to create a dedicated educational forum for the sharing of experiences and techniques while harmonizing data collection intervals and patient reported outcomes measures.
Director of Urology, HALO Diagnostics
Dr. Jeffrey Herz, Director of Urology at HALO Diagnostics, is a Board Certified Urologist with specialty in both adult and pediatric urology. He opened his practice in 1980 in Rancho Mirage, California and has been a practicing urologist for 40 years. His expertise has gained him honors as one of the “Top Doctors” from 2005-2018 in the Palm Springs Life Magazine. Dr. Herz graduated from University of Connecticut Medical School with his Doctor of Medicine in 1974. He went on to the University of Southern California in Los Angeles where he completed an internship in General Surgery in July 1975. He later went on to UCLA Medical Center and completed a year of General Surgery residency in 1976. Dr. Herz continued his training with a Urology residency at University of California Davis Medical Center and completed his Urologic residency training at the University of Washington Medical Center in 1980.
SCHEDULE A CONSULTATION
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?
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 for genomic testing to assess the unique tumor biology of each patient to help guide treatment decisions.