In 2022, an estimated 268,490 new cases of prostate cancer will be diagnosed in the US alone.1 Careful monitoring of disease progression (called active surveillance) instead of immediate treatment is the best treatment option for many patients, particularly men who are diagnosed at an early stage, have less aggressive tumors, and are older.2

However, for a portion of patients, focal therapy may be an appropriate treatment to help manage their disease after consideration from their doctor. Either way, there are many hardships people experience while living with the disease.

It is our goal, and the goal of this study, to evaluate the safety, as well as the effectiveness, of using the NanoKnife System as a focal therapy option for patients with intermediate-risk prostate cancer.

What is prostate cancer?

Prostate cancer is cancer that occurs in the prostate, which is the small walnut-shaped gland found in men that produces the seminal fluid that nourishes and transports sperm.2

Prostate cancer is unique in that many prostate tumors do not spread quickly to other parts of the body. Even in cases where prostate cancer spreads, it can often be managed for a long time, allowing those even with advanced prostate cancer, to live with good health and quality of life for many years.3

An important part of managing prostate cancer is monitoring it for growth over time. Based on the pattern of growth, your doctor can decide the best available treatment options and when to give them.3

How is prostate cancer graded?

Prostate cancer is given a grade called a Gleason score, which is the most common prostate cancer grading system used. The score is calculated based on how close the cancer tissue looks like healthy tissue when viewed under a microscope. Cancerous tumors that are less aggressive look more like healthy tissue. Whereas cancerous tumors that are more aggressive are likely to look very different from healthy tissue.3

A pathologist, someone who looks at the cancerous cells under a microscope and does comparisons, will observe the cancer cells in the prostate and assign a score on a scale of 3 to 5. They do this for two sections of the prostate that have cancer growth. The cancer cells that look similar to healthy cells are given a low score. The cancer cells that look less like healthy cells are given a higher score. The two scores are added together to come up with the overall Gleason score, which falls between 6 and 10.3

What are the current treatment options?

Currently, there are six main types of treatment options available for those with prostate cancer. They include:

Active Surveillance

When prostate cancer is not in the advanced stages or immediate treatment options are not yet necessary, active surveillance is suggested. This involves monitoring the cancer for signs that it is worsening. If the cancer is found to be worsening, then a more active treatment will begin, such as those listed below.3

Surgery

Prostate cancer surgery involves the removal of the prostate gland and some of the surrounding lymph nodes. The type of surgery depends on the stage of the disease, the man’s overall health, and other factors.3

Radiation therapy

Radiation therapy for prostate cancer is used to destroy the cancer cells with the use of high-energy rays. A radiation therapy regimen, or schedule, consists of a specific number of treatments given over a set period of time.3

Focal Therapy

Focal therapies are considered less-invasive treatments. They can destroy small prostate tumors without treating the rest of the prostate. These treatments can use different forms of energy to destroy the cancer including heat, cold, or irreversible electroporation. This form of treatment is mostly for intermediate-risk prostate cancer patients.3

Systemic Treatments

Systemic therapy is the use of medication to destroy cancer cells. This type of medication is given through the bloodstream to reach cancer cells throughout the body. Systemic therapies are generally prescribed by a medical oncologist, a doctor who specializes in treating cancer with medication.3

Testosterone Suppression Therapy

This form of treatment is based off of lowering testosterone levels in the patient. Because prostate cancer growth is driven by male sex hormones called androgens, lowering levels of these hormones can help slow the growth of the cancer. The most common androgen is testosterone. Testosterone levels in the body can be lowered in a number of ways including surgical removal of the testicles or by taking drugs that turn off the function of the testicles.3

About the PRESERVE Study using the NanoKnife System

This study was initiated to evaluate the safety, as well as the effectiveness, of using the NanoKnife System as a focal therapy option for patients with intermediate-risk prostate cancer.

What is the NanoKnife System and IRE?

The NanoKnife System is an ablation device used to destroy a targeted area of tissue. The device uses Irreversible Electroporation or IRE, which is a technique in which electrical pulses are applied to targeted cells. The pulses create small holes in the cell membranes as they pass through. After enough pulses are delivered to the cells, the cells die.

The NanoKnife System uses probes that are placed around a targeted area of tissue to deliver electrical pulses. The probes are plugged into a generator that delivers and monitors the procedure. Currently, the NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

View the video below to see an example of how the NanoKnife System IRE technology works.

Get Involved

You are never alone in your fight. There are countless ways to get involved and connected in the prostate cancer support community. Some resources to help you and your loved ones learn more about the disease, get support, and get involved include:

ZERO – The End of Prostate Cancer (zerocancer.org)

Today, ZERO is the destination for taking action to end prostate cancer and making prostate cancer research a national priority. With a new name, ZERO – The End of Prostate Cancer, they are on the front lines in Washington, DC and grassroots communities to provide much needed programs that positively impact the lives of both men at risk and men suffering from this disease.

Us TOO (ustoo.org)

What began back in 1990 with five men in Chicago and an idea to form the first prostate cancer support group has grown into Us TOO International providing comprehensive educational materials and resources along with support services that include more than 200 volunteer-led support groups across the U.S. and abroad. Us TOO was founded by—and continues to be governed by—people directly affected by prostate cancer.

Cited References

1 Cancer Facts & Statistics. American Cancer Society. https://cancerstatisticscenter.cancer.org/#!/cancer-site/Prostate. Published 2022. Accessed February 7, 2022

2 Cancer Facts & Figures 2021. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and figures/2021/cancer-facts-and-figures-2021.pdf. Accessed July 2021.

3 Prostate Cancer. American Society of Clinical Oncology. Accessed November 2020 from https://www.cancer.net/cancer-types/prostate-cancer

Important Risk Information

AngioDynamics, the AngioDynamics logo, NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2022 AngioDynamics, Inc. GL/ON/WP/1036 REV 02 02/2022. All other trademarks are property of their respective owners.

The NanoKnife System when used for the treatment of prostate cancer is an investigational device. Limited by United States law to investigational use.