Prostate Cancer Study in the US

With its potential to completely ablate small prostate tumors, there appears to be huge potential for NanoTherm® therapy as a monotherapy in early to intermediate prostate cancer patients with an opportunity to prolong active surveillance periods, support organ preservation, and enhance the quality of life.

The FDA pre-IDE meeting on the NanoTherm® prostate cancer therapy pre-submission took place in January 2015, the Investigational Device Exemption for NanoTherm® therapy to treat intermediate risk prostate cancer was filed with the FDA in May 2015. With the regulatory submission, we entered the approval process according to plan. We believe that the registration clinical trial will prove that NanoTherm therapy can fulfill the desired outcome, and we are looking forward to working with the FDA teams and advancing the registration process in the USA. A success in the US could finally also be a trigger for a later breakthrough in Europe in this indication. The first USA NanoActivator® was installed in Seattle, Washington, near the University of Washington Medical Center, in November 2015. It will be utilized in the Focal Thermal Ablation Registration Study for Prostate Cancer. This NanoActivator® is similar in design to the five NanoActivator® devices operating at University Hospitals in Germany applying NanoTherm® therapy for the treatment of Brain Tumors. However, the USA NanoActivator® has been modified to apply NanoTherm® therapy for the treatment of Prostate Cancer in addition to the treatment of Brain Tumors.

Key Parameters of the Prostate Cancer Study in the USA

The purpose of the proposed study, which will enroll up to 120 men, is to demonstrate that NanoTherm therapy can focally ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance. The Gleason Score is internationally recognized to classify the extent and growth of a prostate tumor. Today, patients receive standard therapy such as surgery, radiation, or chemotherapy when reaching this diagnostic value. By ablating the lesions, patients are expected to maintain active surveillance and avoid all the well-known side effects of standard therapy, like impairment of urinary and sexual functions.

 

 

Prostate cancer

is the most commonly diagnosed cancer in men in the USA. According to the National Cancer Institute, around 238,590 new cases of cancer will be diagnosed and about 29,720 men will die of prostate cancer in the US in 2013. In the USA alone, over USD 10 billion are spent annually treating prostate cancer; hence the market is ten times larger than for glioblastoma Due to demographic changes and extensive screening, incidence cases are expected to grow significantly in the next ten to 20 years. With the use of PSA testing in the USA during the past decades, prostate cancer has been identified and treated earlier, leading to a sharp decline in prostate cancer that has metastasized outside of the prostate gland. At the time of diagnosis, most men (four out of five) are reported to have localized prostate cancer and, as it is growing slowly, nearly 100% of all men diagnosed with localized prostate cancer live at least five years after diagnosis. There appears to be a major opportunity to develop a valued focal therapy that can be utilized to control the slow growing cancer, and keep it non-aggressive, prevent metastasis during the life of the patients, or become a valuable adjunct to radiations for high-risk and recurrent prostate cancer.