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Initial Experiences of Treating Prostate Cancer with Focal Irreversible Electroporation
Description:
Initial Experiences of Treating Prostate Cancer with Focal Irreversible Electroporation
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T00H09M59S
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Upload Date:
2024-02-05T00:00:00.0000000
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Language: EN.
Segment:0 .
The following video will portray the use of focal irreversible electroporation or IRE in prostate cancer. IRE is a form of focal ablation technology, which has been applied to various solid malignancies, including prostate cancer. IRE functions through the direct application of electrical impulses, which permeates cell membranes to disrupt cell homeostasis, and lead to cell apoptosis, and necrosis.
The benefit of IRE is that it ablates malignant lesions while maintaining the tissue scaffolding, resulting in a presumed greater preservation of genito-urinary function as compared to total prostatectomy. The IRE procedure can be divided into five distinct phases as shown here. The bulk of the procedure is ensuring that the probes are placed in their optimal locations and adequately surrounding the malignancy.
The actual treatment delivery duration is less than 20 minutes. In this video, we will depict both cognitive and MRI ultrasound fusion approaches for field visualization. The procedure begins with administration of general anesthesia. Electrical pulses from IRE can cause muscle contractions so that induction of deep muscle paralysis is vital to ensure that the probes do not move during the procedure.
They are then placed into the lithotomy position. A urethral catheter is inserted. And the field is sterilized. The next stage of the procedure is visualization of the target lesion and the surrounding structures. Live imaging of the field is achieved through a biplanar ultrasound transducer, which is lubricated and placed into the rectum.
The ultrasound probe can be freely rotated in the axial plane to provide a comprehensive view of the prostate and its surrounding anatomy. The sagittal axis can also be adjusted based on the depth of insertion of the ultrasound transducer. A brachytherapy grid is secured above the ultrasound transducer for accurate probe placement and stability throughout the procedure.
The following image shows the patient's lesion on MRI imaging. His lesion is located in the right anterolateral transition zone, extending towards the midline from the level of the base to the mid-gland. These next two clips depict a comprehensive scanning of the prostate using the ultrasound transducer. The hyperechoic structure in the center of the prostate is the Foley catheter placed at the start of the procedure.
Using ultrasound guidance, measurements of the prostate are taken to determine the number of probes needed for adequate ablation of the lesion. Larger lesions will require five to six probes, while smaller lesions will only require two to four probes. IRE of the prostate can be completed cognitively using just a live image from the ultrasound in conjunction with the surgeon's mental map of the lesion based on the pre-biopsy MRI.
However, to more accurately localize and treat the cancerous lesion, the surgeon has an option of using an MRI ultrasound fusion system, which fuses the MRI images to the live ultrasound image of the prostate. Utilizing the EuroNav system, as shown here, allows more precise insertion of probes with the guidance of the electromagnetic tracker, which is the white box seen above the CIVCO stepper.
This fusion system provides this view on an additional screen, which the surgeon can use to localize their probes in relation to the prostatic lesion. When the surgeon inserts a probe such as in a location of D3 in this example, the electromagnetic tracker is able to localize the probe in comparison to the cancerous lesion and in relation to the entire prostate.
This probe is placed correctly just outside of the malignancies bounds. The next portion of the procedure is setting up the NanoKnife machine. After entering the patient's demographics, the number of probes needed for ablation are selected. For this example, we will depict the use of five probes on the procedure planning screen. The location on the screen will be manually adjusted as probes are inserted, and the distances between probes are added.
The probes used in IRE are metallic, monopolar electrodes as seen here. The total area of exposure can be adjusted with the lever on the handle. The greater the exposure surface, the greater the ablation area. In this example, we will expose two centimeters of the probe's metallic surface. The ablation occurs within 5 millimeters radius of the exposed metal.
As such, two centimeters of exposure results in a 3 centimeter ablation zone length with a 1 centimeter diameter. With the use of the MRI ultrasound fusion technology, we can begin inserting the probes through the brachytherapy grid. The probes can be identified as the hyperechoic structures on ultrasound. Re-orienting the ultrasound image to the longitudinal axis can also confirm appropriate probe placement as they are easily visualized and displayed.
In the cognitive approach, the surgeon places the probes using just a live ultrasound image. However, if using the MRI ultrasound fusion system, the surgeon gets an additional confirmation of the location of his probes with respect to the prostatic lesion as depicted in this example here, again. The remainder of the probes are placed. And care is taken to ensure the distances are appropriate.
The ideal distance between the two probes of a pair is 1.5 to 2 centimeters to achieve electrical fields of the adequate strength. To achieve ablation up to the level of the prostatic capsule, the probes are placed within 5 millimeters of the capsule. In this patient's case, the lesion was approaching the midline of the prostate, prompting us to use six probes and result in a larger target margin.
Once the probes have been placed into their appropriate locations, the measured distances are inputted into the NanoKnife machine. This information will guide the voltage selection based on distance to ensure adequate tissue ablation. With all the probes in position, we are ready to begin the treatment phase. Using the automated voltages provided by the machine, we begin by firing 10 test impulses between each probe pair.
The current should run between 20 to 35 amps to allow for adequate ablation, while preventing caustic damage to the patient from high voltages. As seen in this test run, some probe pairs had a low current while others were too high. These specific pairs are manually up-titrated and down-titrated by 10% respectively. And another 10 test impulses can be run. After appropriate titration of voltages, the remainder of the procedure is ready to begin.
A total of 90 pulses are needed for appropriate ablation of the lesion. The 10 test impulses at the appropriate current qualified as a part of that total. As such, the remaining 80 impulses are prepared on the machine. The device charges up and is activated by the surgeon using a foot pedal. The electro ablation occurs through one probe pair at a time, traveling from a positive to a negative node.
As seen, twitching may also occur throughout the procedure during impulse firing. During the procedure, there are microenvironment changes, some of which can be ascertained on imaging. The area immediately adjacent to the probes becomes hyperechoic throughout the probe firing. Of note, the actual area of ablation is greater than the visualized hyperechoic areas. Another microenvironment change is the production of gases at the positive and negative nodes.
At the positive electrode, chlorine gas is produced. And at the negative electrode, hydrogen gas is produced. These gases can impair the visualization after ablation begins, making further needle adjustments, if needed, challenging. Pulse delivery continues and can be followed by the surgeon looking at the current levels, the hyperechoic changes on the ultrasound, and the physical response by the patient.
As the pulses are delivered by the final probe pair, the ablation portion of the procedure is completed. To initiate recovery, the probes and brachytherapy grid are removed. The patient is moved into the supine position, and a perineal pad is placed. They are extubated and then transferred to the PACU. Patients have been tolerating the procedure well and have had minimal blood loss, post-operatively, with little to no hematuria.
They can be discharged later that day and have their Foley catheter removed after five to seven days. At our institution, 22 patients have received IRE treatment. 19 patients received treatment for focal lesions and one each for hemi-gland, quadrant, and anterior gland treatments. One patient had prior radiation therapy. The average preoperative PSA value was 7.91 with a standard deviation of 5.10. At 3, 6, and 12 months of follow-up, the mean PSA values were 2.32, 2.11, and 2.53 respectively, showing an overall decline with a slight rise in PSA values after one year.
Notably, there are only two patients who had 12 months follow-up, given the novel application of the procedure. AUA scores similarly showed a decline as the preoperative average AUA score was 13.23. At 3, 6, and 12 months follow-up, the AUA values were 9.14, 8, and 10.75 respectively. Preoperative SHIM scores were 13.89 with follow-up values at 3, 6, and 12 months of 9.32, 12.23, and 8.33 respectively.
Lastly, amongst 13 patients who received post-operative MRI imaging, one was found to have localized lesion concerning for prostate cancer at 10.3 months. Amongst six patients who received post-operative biopsies, two patients were found to have prostate cancer. One was Gleason 3 plus 4, while the other was 4 plus 3. Both of these patients had received post-operative MRI imaging, but only one of them had a finding concerning for prostate cancer as shown on the top row of the table.
Looking at a longer term study, the research group found that amongst 229 patients who were followed for a median of 60 months, the Kaplan-Meier failure-free survival rates were 91% at three years, 84% at five years, and 69% at eight years. The metastasis-free survival was 99.6%, while prostate cancer specific and overall survival rate was 100%.
During follow-up biopsy, residual clinical significant prostate cancer was found in 24% of cases. And additionally, MRI showed complete ablation in 82% of cases. They did find that short-term urinary continence was preserved but that erections sufficient for intercourse decreased by 13%. In agreement with this paper, we believe that primary focal IRE for prostate cancer is a promising treatment option but that additional long-term studies and external validation of these results are still necessary.
One such pivotal study, the PRESERVE trial, has achieved patient accrual and will be able to contribute to this key information gathering. Lastly, with the information available at this point, the National Institute of Clinical Excellence has approved for the use of IRE for prostate cancer with informed consent.
Segment:0 .
The following video will portray the use of focal irreversible electroporation or IRE in prostate cancer. IRE is a form of focal ablation technology, which has been applied to various solid malignancies, including prostate cancer. IRE functions through the direct application of electrical impulses, which permeates cell membranes to disrupt cell homeostasis, and lead to cell apoptosis, and necrosis.
The benefit of IRE is that it ablates malignant lesions while maintaining the tissue scaffolding, resulting in a presumed greater preservation of genito-urinary function as compared to total prostatectomy. The IRE procedure can be divided into five distinct phases as shown here. The bulk of the procedure is ensuring that the probes are placed in their optimal locations and adequately surrounding the malignancy.
The actual treatment delivery duration is less than 20 minutes. In this video, we will depict both cognitive and MRI ultrasound fusion approaches for field visualization. The procedure begins with administration of general anesthesia. Electrical pulses from IRE can cause muscle contractions so that induction of deep muscle paralysis is vital to ensure that the probes do not move during the procedure.
They are then placed into the lithotomy position. A urethral catheter is inserted. And the field is sterilized. The next stage of the procedure is visualization of the target lesion and the surrounding structures. Live imaging of the field is achieved through a biplanar ultrasound transducer, which is lubricated and placed into the rectum.
The ultrasound probe can be freely rotated in the axial plane to provide a comprehensive view of the prostate and its surrounding anatomy. The sagittal axis can also be adjusted based on the depth of insertion of the ultrasound transducer. A brachytherapy grid is secured above the ultrasound transducer for accurate probe placement and stability throughout the procedure.
The following image shows the patient's lesion on MRI imaging. His lesion is located in the right anterolateral transition zone, extending towards the midline from the level of the base to the mid-gland. These next two clips depict a comprehensive scanning of the prostate using the ultrasound transducer. The hyperechoic structure in the center of the prostate is the Foley catheter placed at the start of the procedure.
Using ultrasound guidance, measurements of the prostate are taken to determine the number of probes needed for adequate ablation of the lesion. Larger lesions will require five to six probes, while smaller lesions will only require two to four probes. IRE of the prostate can be completed cognitively using just a live image from the ultrasound in conjunction with the surgeon's mental map of the lesion based on the pre-biopsy MRI.
However, to more accurately localize and treat the cancerous lesion, the surgeon has an option of using an MRI ultrasound fusion system, which fuses the MRI images to the live ultrasound image of the prostate. Utilizing the EuroNav system, as shown here, allows more precise insertion of probes with the guidance of the electromagnetic tracker, which is the white box seen above the CIVCO stepper.
This fusion system provides this view on an additional screen, which the surgeon can use to localize their probes in relation to the prostatic lesion. When the surgeon inserts a probe such as in a location of D3 in this example, the electromagnetic tracker is able to localize the probe in comparison to the cancerous lesion and in relation to the entire prostate.
This probe is placed correctly just outside of the malignancies bounds. The next portion of the procedure is setting up the NanoKnife machine. After entering the patient's demographics, the number of probes needed for ablation are selected. For this example, we will depict the use of five probes on the procedure planning screen. The location on the screen will be manually adjusted as probes are inserted, and the distances between probes are added.
The probes used in IRE are metallic, monopolar electrodes as seen here. The total area of exposure can be adjusted with the lever on the handle. The greater the exposure surface, the greater the ablation area. In this example, we will expose two centimeters of the probe's metallic surface. The ablation occurs within 5 millimeters radius of the exposed metal.
As such, two centimeters of exposure results in a 3 centimeter ablation zone length with a 1 centimeter diameter. With the use of the MRI ultrasound fusion technology, we can begin inserting the probes through the brachytherapy grid. The probes can be identified as the hyperechoic structures on ultrasound. Re-orienting the ultrasound image to the longitudinal axis can also confirm appropriate probe placement as they are easily visualized and displayed.
In the cognitive approach, the surgeon places the probes using just a live ultrasound image. However, if using the MRI ultrasound fusion system, the surgeon gets an additional confirmation of the location of his probes with respect to the prostatic lesion as depicted in this example here, again. The remainder of the probes are placed. And care is taken to ensure the distances are appropriate.
The ideal distance between the two probes of a pair is 1.5 to 2 centimeters to achieve electrical fields of the adequate strength. To achieve ablation up to the level of the prostatic capsule, the probes are placed within 5 millimeters of the capsule. In this patient's case, the lesion was approaching the midline of the prostate, prompting us to use six probes and result in a larger target margin.
Once the probes have been placed into their appropriate locations, the measured distances are inputted into the NanoKnife machine. This information will guide the voltage selection based on distance to ensure adequate tissue ablation. With all the probes in position, we are ready to begin the treatment phase. Using the automated voltages provided by the machine, we begin by firing 10 test impulses between each probe pair.
The current should run between 20 to 35 amps to allow for adequate ablation, while preventing caustic damage to the patient from high voltages. As seen in this test run, some probe pairs had a low current while others were too high. These specific pairs are manually up-titrated and down-titrated by 10% respectively. And another 10 test impulses can be run. After appropriate titration of voltages, the remainder of the procedure is ready to begin.
A total of 90 pulses are needed for appropriate ablation of the lesion. The 10 test impulses at the appropriate current qualified as a part of that total. As such, the remaining 80 impulses are prepared on the machine. The device charges up and is activated by the surgeon using a foot pedal. The electro ablation occurs through one probe pair at a time, traveling from a positive to a negative node.
As seen, twitching may also occur throughout the procedure during impulse firing. During the procedure, there are microenvironment changes, some of which can be ascertained on imaging. The area immediately adjacent to the probes becomes hyperechoic throughout the probe firing. Of note, the actual area of ablation is greater than the visualized hyperechoic areas. Another microenvironment change is the production of gases at the positive and negative nodes.
At the positive electrode, chlorine gas is produced. And at the negative electrode, hydrogen gas is produced. These gases can impair the visualization after ablation begins, making further needle adjustments, if needed, challenging. Pulse delivery continues and can be followed by the surgeon looking at the current levels, the hyperechoic changes on the ultrasound, and the physical response by the patient.
As the pulses are delivered by the final probe pair, the ablation portion of the procedure is completed. To initiate recovery, the probes and brachytherapy grid are removed. The patient is moved into the supine position, and a perineal pad is placed. They are extubated and then transferred to the PACU. Patients have been tolerating the procedure well and have had minimal blood loss, post-operatively, with little to no hematuria.
They can be discharged later that day and have their Foley catheter removed after five to seven days. At our institution, 22 patients have received IRE treatment. 19 patients received treatment for focal lesions and one each for hemi-gland, quadrant, and anterior gland treatments. One patient had prior radiation therapy. The average preoperative PSA value was 7.91 with a standard deviation of 5.10. At 3, 6, and 12 months of follow-up, the mean PSA values were 2.32, 2.11, and 2.53 respectively, showing an overall decline with a slight rise in PSA values after one year.
Notably, there are only two patients who had 12 months follow-up, given the novel application of the procedure. AUA scores similarly showed a decline as the preoperative average AUA score was 13.23. At 3, 6, and 12 months follow-up, the AUA values were 9.14, 8, and 10.75 respectively. Preoperative SHIM scores were 13.89 with follow-up values at 3, 6, and 12 months of 9.32, 12.23, and 8.33 respectively.
Lastly, amongst 13 patients who received post-operative MRI imaging, one was found to have localized lesion concerning for prostate cancer at 10.3 months. Amongst six patients who received post-operative biopsies, two patients were found to have prostate cancer. One was Gleason 3 plus 4, while the other was 4 plus 3. Both of these patients had received post-operative MRI imaging, but only one of them had a finding concerning for prostate cancer as shown on the top row of the table.
Looking at a longer term study, the research group found that amongst 229 patients who were followed for a median of 60 months, the Kaplan-Meier failure-free survival rates were 91% at three years, 84% at five years, and 69% at eight years. The metastasis-free survival was 99.6%, while prostate cancer specific and overall survival rate was 100%.
During follow-up biopsy, residual clinical significant prostate cancer was found in 24% of cases. And additionally, MRI showed complete ablation in 82% of cases. They did find that short-term urinary continence was preserved but that erections sufficient for intercourse decreased by 13%. In agreement with this paper, we believe that primary focal IRE for prostate cancer is a promising treatment option but that additional long-term studies and external validation of these results are still necessary.
One such pivotal study, the PRESERVE trial, has achieved patient accrual and will be able to contribute to this key information gathering. Lastly, with the information available at this point, the National Institute of Clinical Excellence has approved for the use of IRE for prostate cancer with informed consent.
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