Fox Chase Cancer Center Researchers Open Clinical Trial That Could Help Men Avoid Surgery to Remove Prostate

Researchers at Fox Chase Cancer Center have begun recruiting for a clinical trial called PRESERVE that will evaluate the safety and efficacy of the NanoKnife System to treat patients with intermediate-risk prostate cancer. One of the measurements of treatment effectiveness is to assess the number of patients who are cancer-free one year following treatment.

NanoKnife is a focal therapy, a form of treatment that is typically considered less invasive and that can eliminate cancer cells through different forms of energy such as electricity, heat, and cold, all while sparing normal cells.

“I think this technology is the future, and I’m hoping that in 10 to 15 years I’ll be doing surgery to remove the prostate in a very limited number of patients. Those types of procedures really affect a patient’s quality of life, and if we can avoid that it would be ideal,” said Andres Correa, MD, an assistant professor in the Department of Urology and one of the clinicians heading the trial.

“NanoKnife is a technology that uses electricity to create a very high voltage between two probes. The lesion that has been identified and biopsied beforehand is placed between these probes and the electricity disrupts the integrity of cells, what we call the cell membrane. That’s how the cancer is affected,” he said.

PRESERVE, the Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue, is being conducted with several other sites in the United States, but Fox Chase is the only site in Pennsylvania.

Participation in the NanoKnife research study would be an addition to the two types of focal therapy that Fox Chase already offers to treat prostate cancer. The first of these is cryoablation, in which a needle probe is used to freeze and kill diseased prostate tissue. The second is high-intensity focused ultrasound, which uses sound waves to create heat that destroys diseased tissue.

For the new study, researchers are recruiting up to 118 subjects who will be treated with NanoKnife and standard care. They will be observed closely through prostate specific antigen (PSA) scores, MRIs, and biopsies through 12 months and will be followed for up to five years to monitor whether cancer returns after treatment. Correa will be conducting the Fox Chase arm of the trial with David Chen, MD, FACS, a professor in the Department of Surgical Oncology.

Chen said that historically prostate cancer has been overtreated, often favoring aggressive therapies like surgery or radiation for individuals who may not necessarily need them. With the PRESERVE trial, they hope to provide conclusive evidence that the NanoKnife System is best suited for these “in-between” patients.

“This technology fills a role for men who may need some treatment but for whom the traditional treatment is probably too much and can cause worse side effects or possible complications. It’s an intermediate step that allows us to do something about the cancer while not subjecting these men to the same sort of radical treatment that we historically felt was needed,” said Chen.

“We’re excited about the expected role of NanoKnife in this application, and we recognize that there are probably other types of devices that may come in the future,” he said.

Correa added that the PRESERVE trial will also help researchers and clinicians better understand how therapies will evolve over time and impact cancer recurrences and quality of life.