Participation

INTRODUCTION

WHAT IS MAGFORCE?

MagForce was founded in 1997 and specializes in the development of advanced nanomedicine for innovative cancer therapies. Its nanotechnology-based therapy (NanoTherm™) is currently being used to treat patients with advanced brain cancer in the European Union. MagForce is now examining this technology as a possible treatment for patients with prostate cancer.

WHAT IS THE MAGFORCE® CLINICAL STUDY?

Clinical trials look at new ways to prevent, detect, or treat disease. They are a part of clinical research and at the heart of almost all medical advances. The goal of clinical trials is to determine if a new test or treatment is effective and safe. The MagForce® Clinical Study is being conducted to determine if the NanoTherm™ Thermal Ablation Therapy is safe and effective in the treatment of certain patients’ prostate cancer.

WHY DO PEOPLE PARTICIPATE IN A CLINICAL TRIAL?

People participate in clinical trials for a number of different reasons. Some people participate to help others in that the hope they are helping to contribute to the advancement of science. Some people participate in the hope of receiving a benefit from the experimental treatment for their illness or disease. Others participate in order get additional care and attention from the clinical staff conducting the trial. Finally, some may participate for the financial benefit or other type of compensation that may be available.

RISKS & BENEFITS

WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATING?

In this stage of the Clinical Study, you will directly benefit from this experimental treatment for prostate cancer. If your NanoTherm™ treatment is effective in ablating your cancer lesion, you may be able to return to active surveillance instead of needing to proceed to definitive treatment such as a prostatectomy or radiation therapy. In addition, a potential benefit of your participation is that you will undergo an Axumin® PET/CT scan, a test that is generally not performed prior to prostate cancer treatment. There is a possibility that the results of this test may help your physician determine how best to perform your surgery by better-defining the location of your tumor.

WHAT ARE SOME OF THE POSSIBLE RISKS OF PARTICIPATING?

There are risks to taking part in any research study. There is a risk the NanoTherm™ particles and treatment may cause problems (side effects), which may be mild, moderate, or very serious. The injection of the nanoparticles into your prostate may result in bleeding, infection, or inflammation; these are uncommon side effects. The side effects that patients who have thus far experienced with this treatment have been: sweating, mild discomfort, skin irritation or burning as well as an increase of body temperature, blood pressure and heart rate. To date, surgeons performing radical prostatectomy in patients who have been previously treated with NanoTherm™ injection and activation have not identified any problems with surgery.

ARE ALL OF THE POTENTIAL RISKS KNOWN?

It is important to note that the NanoTherm™ technology is investigational for use in ablating prostate cancer tissue, so all the potential side effects are still unknown at this point. In fact, this is one of the main reasons that MagForce is currenting undertaking this Clinical Study — to study its safety in the treatment of prostate cancer.

HOW CAN I LEARN MORE ABOUT THE POTENTIAL RISKS?

Prior to participating in the clinical study, all potential subjects will have a meeting with one of the study’s principal investigators. This initial meeting will help you learn more about the clinical trial and help answer any questions you may have. Prior to enrolling in the study, you will be asked to review and sign an “Informed Consent” which provides extensive detailed information related to the risks and benefits of participation as well as the details of each step of the study. The principal investigator will be available to answer any questions that you might have about all known and potential risks. At any point during this process of learning about the study, you may opt to proceed with treatment by your physician.

AXUMIN® PET/CT SCAN

PET/CT SCAN

Subjects in the clinical study will undergo PET/CT scans. This scan combines two imaging techniques. A positron emission tomography (PET) scan shows physiologic (functional) changes in the body, and a computed tomography (CT) scan shows a detailed depiction of your anatomy, where tumors may reside. The two imaging techniques provide the physician with detailed information about the extent and location of your disease.

AXUMIN®

The PET component of the PET/CT uses Axumin®. It is an FDA-approved diagnostic imaging agent, also known as a “tracer,” that may help your physician better determine the location of any prostate cancer that is present. Further information on Axumin® can be provided at your request from our Medical Liaison.

ENROLLING SUBJECTS

STAGE 1 IS COMPLETED

MagForce USA has completed Stage 1 of the Clinical Study. MagForce USA and its physician investigators developed a focal prostate cancer procedure based on commercially available targeted prostate biopsy technology used globally today. In Stage 1, ten patients were treated with this procedure and extensively monitored for side effects during the individual steps of the ablation procedure process. Initial findings show only minimal treatment related side effects, which were tolerable and similar to those commonly associated with biopsies.

STAGE 2A IS COMPLETED

In Stage 2A, the ablation procedure was conducted in a single day. The goal of this stage was to demonstrate effectiveness of a single-day NanoTherm™ ablative treatment procedure as well as confirm the associated minimal side effects seen in Stage 1. In Stage 2A, eight patients were treated with this procedure and extensively monitored for side effects during the ablation procedure and the follow-up visits. Initial findings showed the same minimal treatment related side effects, which were tolerable and similar to those commonly associated with biopsies.

STAGE 2B IS NOW ENROLLING

Now that Stage 2A is completed, MagForce USA is beginning enrollment in Stage 2B. We will be enrolling subjects who have Intermediate Risk Prostate Cancer (as judged by Active Surveillance) and who are appropriate candidates for the focal ablative treatment process. These subjects will undergo the single NanoTherm™ treatment followed by a targeted prostate biopsy three to five months after treatment to determine if the treatment was effective and to determine if no further definitive treatment is required.
magforce Nano Therm AS1

NanoTherm™

MagForce Nan Activator

NanoActivator®

For More Information on the Study
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