INVESTIGATIONAL FOCAL THERAPY FOR PROSTATE CANCER AT HALO DX
Desert Medical Imaging, a part of HALO Diagnostics, has been the leading provider of medical imaging services in the Coachella valley for over two decades.
FOR PATIENT INFORMATION
Prostate Cancer Clinical Trial at DMI
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?
Enter your answer here. Be thoughtful, write clearly and concisely, and consider adding written as weAs 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.ll as visual examples. Go over what you’ve written to make sure that if it was the first time you were visiting the site, you’d understand your answer.
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.
PARTICIPATING IN THIS STUDY IS COMPLETELY VOLUNTARY
IF YOU ARE INTERESTED IN JOINING THIS STUDY, PLEASE CONTACT THE RESEARCH TEAM BELOW.
John F. Feller, M.D.
Ms. Bernadette M. Greenwood,
BSc, PG Cert., RT(R)(MR)
Data Manager/Research Coordinator:
To learn more about the study, please enter your information: