Frequently Asked Questions

For Patients:

A: NanoKnife, also known as irreversible electroporation (IRE), is a minimally invasive procedure used to treat prostate cancer. It involves delivering high-voltage electrical pulses to cancerous cells which disrupts their cell structure causing irreversible damage, ultimately leading to cell death.

A: Patients who may benefit from NanoKnife treatment typically have the following characteristics:

 

Prostate cancer contained within the prostate gland: The cancer is confined to the prostate gland and has not spread to other parts of the body or outside the capsule of the prostate gland.

 

Prostate cancers that are considered low or moderate risk: This is based on an assessment method called the Gleason Scoring System which determines how aggressive the cancer cells appear under the microscope.  Patients with a cancer that have a Gleason Score of 7, and some with Gleason Score 6 or 8 are candidates.

 

Desire for Minimally Invasive Treatment: Patients who prefer minimally invasive treatment options and wish to preserve quality of life, including urinary and sexual function, may consider NanoKnife.

A: During a NanoKnife procedure, thin needles are inserted into the prostate gland using image guidance with ultrasound. Once in place, electrical pulses are delivered through these needles, targeting and destroying cancerous cells while preserving surrounding healthy tissue.  Unlike other forms of focal therapy such as HIFU (High Intensity Focused Ultrasound), radiofrequency ablation or cryotherapy, Nanoknife does not use heat or cold to cause cell death.  As a result, there is less scarring and potential injury to surrounding structures.

A: NanoKnife technology was first developed by researchers exploring alternative methods for tissue ablation, particularly in areas where traditional techniques such as surgery or radiation therapy posed risks to surrounding healthy tissue. Initial preclinical and clinical studies focused on demonstrating the safety and feasibility of using high-voltage electrical pulses to induce cell death selectively in cancerous tissue while sparing adjacent structures.

 

Once the effectiveness of NanoKnife was established in the laboratory, NanoKnife has been used in medical practice for the treatment of various cancers since the early 2000s. The technology was initially developed for tissue ablation and was later adapted for the treatment of solid tumors, including prostate cancer.

 

The use of NanoKnife for the treatment of prostate cancer received regulatory approval in various countries at different times. In the United States, for example, NanoKnife received clearance from the Food and Drug Administration (FDA) for the ablation of soft tissue, including prostate tissue, in 2006. Canada shortly followed with their approval.  Since then, its application for the treatment of prostate cancer has been studied extensively in clinical trials, with growing evidence supporting its efficacy and safety. 

A: While NanoKnife has shown very promising results in the treatment of prostate cancer, its use is still considered relatively new compared to more established treatment modalities such as surgery and radiation therapy. However, as clinical experience and evidence continue to accumulate, NanoKnife is increasingly recognized as a viable option for certain patients, particularly those with localized prostate cancer who may not be suitable candidates or wish to avoid the side effects that may be experienced with traditional treatments. Ongoing research and clinical experience will further elucidate NanoKnife’s role in the treatment of prostate cancer and its long-term benefits.

A: NanoKnife is an effective treatment option for prostate cancer, but it’s important to understand that no treatment guarantees a definitive cure. Some patients may experience complete remission of their cancer, while others may require additional treatments or experience cancer recurrence over time. The long-term success rates of NanoKnife for prostate cancer can vary depending on various factors such as the stage and grade of the cancer, the patient’s overall health and age, and the expertise of the medical team performing the procedure. North Toronto Prostate Centre was the first to offer this treatment in Canada.  After an average of 5 years of following patients who had Nanoknife treatment, studies have shown excellent cancer control results similar to patients who had surgery, while preserving urinary and sexual function.  It is important to note that success in prostate cancer treatment is measured after an average of 10, 15, and 20 years of following patients which is not available for Nanoknife since it was only developed approximately 10 years ago. 

A: Prostate MRI is recommended, but not required to proceed to NanoKnife therapy.  Our expert team at North Toronto Prostate may be able to assist you in undergoing a prostate MRI prior to your procedure if it is felt to be necessary.

 

MRI imaging enhances the accuracy and effectiveness of NanoKnife treatment for prostate cancer by providing detailed anatomical information about the prostate gland and surrounding structures. This allows for precise treatment planning, real-time guidance during the procedure, and accurate assessment of treatment response, ultimately improving outcomes and reducing the risk of complications.  After the Nanoknife procedure, you will need a prostate MRI to help measure success.

A: Yes, if NanoKnife treatment fails to effectively control the prostate cancer or if there is a recurrence of the cancer elsewhere in the gland, radical prostatectomy (surgical removal of the prostate gland) or radiation therapy (high-energy beams to kill cancer cells) may be safely considered as alternative treatment options. 

 

In 2022, this question was addressed by van Riel et al in a study published in the British Journal of Urology International.  In this study involving 39 patients, surgery was feasible without difficulties after NanoKnife treatment with medium‐term oncological and functional outcomes similar to those seen with primary radical prostatectomy.

 

A: The follow-up protocol after focal therapy, such as NanoKnife, typically involves a combination of regular monitoring and imaging studies to assess treatment effectiveness and detect any signs of cancer recurrence.  This may differ depending on patient factors and surgeon preference.  Here’s what the follow-up process may entail:

 

Post-Treatment Evaluation: After undergoing NanoKnife or other focal therapy, patients will have regular follow-up appointments with their Urologist. During these visits, the provider will evaluate the patient’s recovery, address any immediate concerns or side effects, and discuss the next steps in follow-up care.

 

PSA Monitoring: Prostate-Specific Antigen (PSA) blood tests are routinely performed to monitor PSA levels, which can indicate the presence or progression of prostate cancer. PSA levels should gradually decline following successful treatment. Persistent or rising PSA levels may suggest cancer recurrence or residual disease and may prompt further investigation.

 

Imaging Studies: Imaging studies such as MRI (Magnetic Resonance Imaging) will be performed about 6 months following the procedure. MRI can help detect any residual or recurrent cancerous lesions that may require additional treatment.

 

Biopsy: In some cases, follow-up biopsies of the prostate may be recommended to evaluate treatment response and detect any residual or recurrent cancer. Targeted biopsies, guided by MRI or ultrasound imaging, may be performed to specifically sample areas of concern identified during follow-up evaluations. Routine prostate biopsy is not mandatory.

 

Symptom Assessment: Patients will be encouraged to report any new symptoms or changes in urinary, sexual, or bowel function to their Urologist promptly.

 

Long-Term Monitoring: Long-term follow-up is essential for monitoring treatment outcomes and detecting late recurrence or progression of prostate cancer. Patients should maintain regular follow-up appointments with their Urologist even after initial treatment success to ensure ongoing monitoring and management of their condition.

A: There could be several reasons why your urologist may not discuss focal therapy for your prostate cancer:

 

Expertise and Training: Your urologist may not have extensive experience or training in performing focal therapy.  Focal therapy techniques require specialized skills and expertise, and not all urologists may be proficient in these procedures.

 

Treatment Guidelines: Current clinical guidelines and recommendations for prostate cancer treatment may prioritize traditional approaches such as surgery (prostatectomy) or radiation therapy for certain patients, depending on factors such as cancer stage, grade, and risk category.  Focal therapy, while emerging as a promising option, does not yet have a duration of follow-up that has allowed for widespread endorsement or inclusion in all standard treatment guidelines.

 

Patient Selection Criteria: Focal therapy is typically considered suitable for patients with localized prostate cancer and more favorable disease characteristics.  Your urologist may determine that focal therapy is not appropriate for your specific case based on factors such as tumor size, location, aggressiveness, and your overall health status.

 

Access and Availability: Access to focal therapy may be limited in certain healthcare settings or geographic regions.  Your urologist may not discuss focal therapy options if they are not readily available or accessible in your area, or if there are logistical challenges associated with undergoing these procedures.

 

Personal Bias or Preference: Like all healthcare providers, urologists may have personal biases or preferences regarding treatment approaches based on their clinical experiences, training, and familiarity with specific techniques. Your urologist may prefer traditional treatment methods or may be more comfortable recommending options with which they have greater expertise.

A: The recovery process after NanoKnife treatment for prostate cancer can vary from person to person, but here are some general aspects to consider:

 

Immediate Post-Procedure Period: Following NanoKnife treatment, you may experience some discomfort or soreness in the pelvic area, which can typically be managed with pain medications prescribed by your surgeon.  After removal of your urinary catheter, you may also have temporary urinary symptoms such as frequency, urgency, or difficulty urinating, which should improve over time.

 

Activity Restrictions: While you can continue to walk, drive and climb stairs with a catheter in place, strenuous activity and heavy lifting is best avoided.  Following catheter removal, in most patients the timeline for returning to normal activities, including work, will depend on factors such as your overall health, the nature of your job, and how well you’re recovering from the procedure.  Most patients can return to work within a few days to a few weeks after NanoKnife treatment.  Others may need more time off, especially if their job involves physical exertion or prolonged sitting.

A: Yes, NanoKnife treatment can be repeated, if necessary, although the decision to repeat the procedure will depend on several factors, including response to initial treatment, presence of disease progression, overall health, and patient preference.

 

Repeating NanoKnife treatment is uncommon but would carry similar risks, side effects and considerations as the initial procedure.

A: Several factors may influence the decision to choose NanoKnife over radiotherapy (external beam or brachytherapy) or radical prostatectomy (surgical removal of the prostate gland) for prostate cancer treatment:

 

Minimally Invasive Approach: NanoKnife offers a minimally invasive treatment option for prostate cancer, which may be appealing to some patients who wish to avoid the potential risks and complications associated with major surgery (prostatectomy) or radiation therapy.  By selectively targeting cancerous tissue while sparing surrounding healthy structures such as nerves and blood vessels Nanoknife can preserve quality of life relative to other treatment options. The procedure typically involves no hospital stay, quicker recovery times, and reduced risk of certain side effects such as urinary incontinence and erectile dysfunction compared to surgery.

 

Repeatable Treatment Option: NanoKnife treatment can be repeated if necessary, providing flexibility in managing recurrent or residual prostate cancer following initial treatment.

 

Alternative to Radiation Therapy: For patients who are not candidates for or prefer to avoid radiation therapy due to factors such as the potential for life altering side effects, prior radiation exposure or intolerance to radiation, NanoKnife may offer an alternative treatment option with comparable oncologic outcomes and potentially fewer side effects.

 

Maintenance of Treatment Options:  With radiotherapy, if treatment fails, surgery is often not possible or carries considerably higher risks of complications.  With Nanoknife therapy, in cases of recurrence or residual disease, all treatment options remain open including radiotherapy and radical prostatectomy.  Because Nanoknife targets cancer through electroporation and not heat, the scarring associated with ‘heat-based’ treatments such as HIFU does not preclude other treatment options.

 

Ultimately, the choice between NanoKnife, radiation, or surgery for prostate cancer treatment should be based on a thorough evaluation of the patient’s specific circumstances, including cancer stage, grade, risk factors, and treatment preferences, in collaboration with their healthcare team.  Each treatment option has its own benefits, risks, and considerations, and the decision should be guided by the principles of shared decision-making and personalized care.

A: Focal therapy, while emerging as a promising option, does not have the same duration of follow-up experience associated with traditional treatments such as surgery or radiotherapy.  Because of the costs associated with treatment, health care policy makers may not choose to endorse newer technologies until there is a duration of follow-up deemed acceptable to demonstrate equivalency with conventional treatment options.   

A:  While NanoKnife and HIFU are both minimally invasive treatments for prostate cancer, they differ in multiple ways, which may impact treatment choice:

 

  1. Mechanism of Action: NanoKnife uses high-voltage electrical pulses to disrupt cancer cells’ membranes, causing cell death. HIFU, on the other hand, utilizes focused ultrasound waves to generate heat, which destroys cancerous tissue. The heat and consequent scarring associated with HIFU is responsible for some of the differences in terms of side effects, recovery, and feasibility for salvage procedures such as surgery (radical prostatectomy) in the event of treatment failure.
  2. Treatment Precision: NanoKnife offers precise targeting of cancerous tissue while preserving surrounding structures, such as nerves and blood vessels. HIFU also aims to preserve healthy tissue, but the accuracy may vary depending on factors such as prostate size and location of the tumor.  With HIFU, certain patients may not be a candidate for treatment due to tumour location or prostate anatomy.  This is usually not the case with NanoKnife.
  3. Side Effects and Complications: Both NanoKnife and HIFU are associated with potential side effects and complications, such as urinary symptoms, erectile dysfunction, and bowel problems. To date, there have been no head-to-head trials, however, the incidence and severity of serious side effects is exceptionally low with Nanoknife. 
  4. Recovery Time: Recovery time following NanoKnife and HIFU treatments may differ. NanoKnife typically involves a shorter recovery period compared to HIFU, with most patients returning to normal activities within a few days to weeks after the procedure.

 

In summary, both NanoKnife and HIFU offer minimally invasive treatment options for prostate cancer. The choice between the two modalities should be based on factors such as tumor characteristics, treatment precision, side effects, recovery time, and patient preferences, in consultation with a healthcare provider.

For Physicians:

A: NanoKnife, also known as irreversible electroporation (IRE), is a minimally invasive procedure used to treat prostate cancer. It involves delivering high-voltage electrical pulses to cancerous cells creating nano-sized pores in the cellular membrane leading to permeabilization, disruption, apoptosis and cell death.

 

A: Patients who may benefit from NanoKnife treatment typically have the following characteristics:

 

Localized Prostate Cancer: The cancer is confined to the prostate gland and has not spread to other parts of the body.

 

Low to High Risk: Patients with low to high risk prostate cancer, as determined by factors such as Gleason score, PSA levels, and tumor stage, may be suitable candidates for NanoKnife treatment.  Patients with Gleason Score 6 with MRI lesions of PIRADS score of 3 to 5, any Gleason Score 7 or low volume Gleason Score 8 are eligible for Nanoknife IRE.

 

Desire for Minimally Invasive Treatment: Patients who prefer minimally invasive treatment options and wish to preserve quality of life, including urinary and sexual function, may consider NanoKnife.

A:  After NanoKnife treatment for prostate cancer, the prostate tissue that has been destroyed undergoes a process known as necrosis, where the cancerous cells die and are gradually removed by the body’s natural healing mechanisms. Here’s what happens to the prostate tissue following NanoKnife treatment:

 

Cell Death (Necrosis): NanoKnife works by delivering high-voltage electrical pulses to cancerous cells, causing irreversible damage to their cell membranes. This leads to cell death, known as necrosis, within the targeted areas of the prostate gland.

 

Inflammatory Response: Following cell death, the body initiates an inflammatory response to remove the damaged tissue and promote healing. Immune cells, such as macrophages, infiltrate the area to engulf and digest the dead cells, clearing away the debris.

 

Resorption and Scar Formation: Over time, the necrotic tissue is gradually resorbed and replaced by fibrous tissue, leading to the formation of scar tissue within the treated areas of the prostate. This process helps to remodel the tissue and restore the structural integrity of the prostate gland.

 

Resolution of Symptoms: As the inflammatory response subsides, swelling will improve and a gradual return to normal urinary function is expected.

 

Long-Term Effects: Over the long term, scar tissue forms within the prostate gland.  The preserved healthy tissue surrounding the treated areas helps to maintain urinary and sexual function, minimizing the risk of treatment-related side effects.

 

Overall, the prostate tissue destroyed by NanoKnife undergoes a process of natural healing and remodeling, with the body’s immune system playing a key role in removing the damaged cells and promoting tissue repair.

 

A: Currently, Nanoknife IRE should NOT be considered part of the standard of care for patients with clinically localized prostate cancer.  Guidelines clearly indicate that accepted treatment options would be surveillance, surgery or radiation.  While NanoKnife has shown very promising results in the treatment of prostate cancer, its use is still considered relatively new compared to more established treatment modalities such as surgery and radiation therapy.  As clinical experience and evidence continue to accumulate, NanoKnife is increasingly recognized as a viable option for certain patients, particularly those with localized prostate cancer who may not be suitable candidates or wish to avoid the side effects that may be experienced with traditional treatments. Ongoing research and clinical experience will further elucidate NanoKnife’s role in the management of prostate cancer and its long-term outcomes.

A:  In a 2023 study published in the British Journal of Urology entitled “Median 5- year outcomes of primary focal irreversible electroporation for localised prostate cancer” Scheltema et al. analysed data from a total of 229 patients with a median follow-up of 5 years and showed that focal IRE might be positioned as a treatment option for patients with unifocal localized prostate cancer, allowing avoidance of radical treatment in > 80% at 5 years and perhaps up to 70% at 10 years, thereby obtaining improved functional outcomes.  Metastasis-free survival was 99.6%, prostate cancer specific survival and overall survival were 100%. Short-term urinary continence was preserved in 98% of patients and erections sufficient for intercourse decreased by 13% compared to baseline (71% to 58%).

A: MRI plays an important role in various aspects of NanoKnife treatment for prostate cancer:

 

Pre-Treatment Planning: MRI imaging is used before NanoKnife treatment to precisely identify the location, size, and extent of the prostate tumor. This detailed imaging helps the healthcare team plan the procedure and determine the optimal placement of the NanoKnife electrodes to target the cancerous tissue while minimizing damage to surrounding healthy structures.

 

Real-Time Guidance: During the NanoKnife procedure, MRI imaging may be used in real-time to guide the insertion of thin needles (electrodes) into the prostate gland. This ensures accurate placement of the electrodes within the tumor and helps confirm that the treatment targets are being effectively treated while avoiding critical structures such as nerves, blood vessels and the rectum.

 

Assessment of Treatment Response and Monitoring: After NanoKnife treatment, MRI imaging may be performed periodically to assess the response of the prostate tumor to the therapy. Changes in tumor size, morphology, and enhancement patterns observed on MRI scans can provide valuable information about the effectiveness of the treatment and help guide further management decisions.  Regular MRI scans, along with other monitoring tests such as PSA (Prostate-Specific Antigen) levels, enable healthcare providers to detect any signs of cancer recurrence and intervene promptly if necessary.

A: Yes, if NanoKnife treatment fails to effectively control the prostate cancer or if there is a recurrence of the cancer elsewhere in the gland, radical prostatectomy (surgical removal of the prostate gland) or radiation therapy (high-energy beams to kill cancer cells) may be safely considered as alternative treatment options. 

 

In 2022, this question was addressed by van Riel et al in a study published in the British Journal of Urology International.  In this study involving 39 patients, surgery was feasible without difficulties after NanoKnife treatment with medium‐term oncological and functional outcomes similar to those seen with primary radical prostatectomy.