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.