The Dutch Government Elects to Sponsor the ENFORCE Trial – A Fully Funded RCT That Includes the Nanoknife System for Prostate Treatment

We are pleased to offer congratulations to Professor Jurgen Fütterer and his team at Radboud University Medical Centre in the Netherlands, for having successfully secured €3.8 million from the Dutch National Health Care Institute and ZonMw towards the ENFORCE trial, a fully funded Randomised Controled Trial for Focal Therapy which incorporates the NanoKnife System as a treatment option for prostate cancer. The trial is set to begin in September 2023, and will be available to men with localised intermediate risk prostate cancer who are eligible for radical prostate removal or radiotherapy according to current guidelines.

Currently, health insurance companies in the Netherlands do not reimburse for Focal Therapy treatment options (ultrasound ablation (HIFU or TULSA) and irreversible electroporation (IRE)) because the methods have not yet been proven as effective. The National Health Care Institute has therefore now designated these therapies as Potentially Promising Care, a grant scheme implemented by The Dutch National Health Care Institute and ZonMw, commissioned by the Ministry of Health. The researchers are specifically looking at quality of life. If the results are positive, these treatments will be eligible for inclusion in the basic insurance package.

Laura Piccinini, AngioDynamics’ International Senior Vice President/General Manager, congratulates the team, saying “I am thrilled for Professor Fütterer and the team at Radboud University Medical Center for obtaining this support. I anticipate that this trial will contribute towards the accessibility of the NanoKnife System as a treatment option to patients requiring prostate cancer treatment and enriching the lives of numerous men in the Netherlands.”

Jurgen Fütterer, professor of Image-Based Oncological Interventions at Radboudumc, said “Previous research shows that focal therapy is a safe option with good tumor control and few side effects. We now want to investigate this in the Netherlands as well and reduce the risk of bothersome side effects for future patients. In this study, we are investigating the effectiveness, complications and costs of focal therapy and comparing it with the current standard treatment.”

Michiel Sedelaar, Urologist at Radboud UMC said, “Men with prostate cancer often have many years of life ahead of them. But those years are regularly accompanied by side effects such as incontinence, impotence and urinary and defecation complaints. I hope this treatment will lead to fewer side effects in certain groups of patients and therefore a better quality of life.”

Read more on the Zorginstituut Netherlands website.

NanoKnife tumor environment technology image

Representation of irreversible electroporation (IRE) using the NanoKnife System