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?
ARE ALL OF THE POTENTIAL RISKS KNOWN?
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.