Name:
Focal High-Intensity Focused Ultrasound Ablation of the Prostate
Description:
Focal High-Intensity Focused Ultrasound Ablation of the Prostate
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T00H18M58S
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Upload Date:
2023-10-19T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 INTRODUCTION.
LAUREN R. ABRAMS: High-intensity focused ultrasound for the focal ablation of prostate cancer. With an estimated incidence of over 191,000 new cases in 2020, prostate cancer comprises over 10% of all new cancer cases each year in the United States. Historically, whole gland treatment has been offered in the form of radical prostatectomy and radiation therapy. With these treatment modalities, men are at risk for collateral damage to surrounding nerves, sphincter, and other adjacent organs such as bladder and rectum.
LAUREN R. ABRAMS: A prospective multicenter trial of 434 patients demonstrated that 23% of patients reported clinically significant treatment regret after radical prostatectomy, external beam radiotherapy, and brachytherapy. With the advancement of early detection tools for prostate cancer, including multiparametric magnetic resonance imaging, and MRI/ultrasound fusion targeted biopsies, urologists have the ability to better localize prostate cancer within the prostate.
LAUREN R. ABRAMS: There has been increased interest in focal or targeted therapies that carry less morbidity than traditional whole gland treatments. Whole gland high-intensity focused ultrasound ablation has notable downsides, including risk of urethral stricture and erectile dysfunction. The prostatic urethra is treated requiring extended catheterization, and there's significant risk of requiring a post-HIFU procedure.
LAUREN R. ABRAMS: Thus, we believe that hemiablation is the most favorable focal HIFU treatment to optimize cancer control and minimize side effects. A 2016 consensus panel concluded that ideal prostate cancer for focal therapy is a Gleason 3 plus 4 lesion that is location and size favorable to the specific treatment modality. HIFU technology was pioneered at Indiana University in the 1970s, with the first device being built in 1996.
LAUREN R. ABRAMS: In 2000, the first research protocol for HIFU treatment in the United States was drafted at a cancer symposium at the Indiana University School of Medicine. In 2007, Drs. Michael Cook, Thomas Gardner, and others published the first 20 patients treated with HIFU, and reported few side effects and the potential benefits in the treatment of early stage prostate cancer.
LAUREN R. ABRAMS: The Sonablate HIFU device has 510(k) clearance in the United States for ablation of prostate tissue since 2015. HIFU uses an ultrasound transducer that focuses ultrasound beams on a preset point up to 4 centimeters from the energy source without injuring intervening tissue. This ultrasound transducer generates a temperature of at least 55 degrees Celsius, which leads to tissue destruction by coagulative necrosis and cavitation of the target.
LAUREN R. ABRAMS: The heat denatures the proteins and lipoproteins in the cell membranes leading to coagulative necrosis. Microbubble formation and collapse in these tissues leads to cavitation. These microbubbles appear hyperechoic on ultrasound and allow for visualization of treatment effect. HIFU for prostate cancer has been applied to various clinical scenarios, including partial and whole gland treatment, as well as in primary and salvage settings.
LAUREN R. ABRAMS: The focus of this video is on the focal treatment or hemiablation of localized prostate cancer. Indications for HIFU treatment of localized prostate cancer include a visible lesion on MRI that is concordant with biopsy pathology. This allows for MRI/ultrasound fusion targeting of the lesion during treatment. Generally, we recommend focal HIFU in patients with a single side, low-volume Gleason 3 plus 4 lesion.
LAUREN R. ABRAMS: We avoid treatment of patients with Gleason 4 plus 3 disease or greater, unless life expectancy is less than 15 years. All focal therapies carry the risk of an incomplete treatment or failure to completely eradicate the cancer, both within the treatment zone and outside of the treatment zone. Patients with a greater than 15 years life expectancy are at an increased risk of symptomatic metastatic prostate cancer, and thus, focal HIFU should be avoided.
LAUREN R. ABRAMS: The various HIFU ablation patterns are displayed here. And again, we believe hemiablation is the most favorable to optimize cancer control and minimize side effects. Contraindications to HIFU include a large prostate with greater than 4 centimeters distance of treatment, as well as the presence of calcifications greater than 1 centimeter.
LAUREN R. ABRAMS: Objects such as metal implants, stents, and brachytherapy seeds can interfere with therapeutic soundwaves, and HIFU should be avoided in patients with an active urinary tract infection. HIFU is performed as an outpatient surgery. Patients undergo a preoperative MRI and ultrasound fusion biopsy and found to have concordant pathology. Patients are counseled on the nature of prostate cancer and treatment risks, benefits, and alternatives, and informed consent is obtained.
LAUREN R. ABRAMS: All patients undergo a routine preoperative medical assessment including urine culture. They may continue their anticoagulation throughout the procedure. The day prior to the procedure, patients are maintained on a clear liquid diet and undergo a bowel preparation by drinking 10 ounces of magnesium citrate in the morning and evening prior to surgery.
LAUREN R. ABRAMS: The procedure may be performed under spinal or general anesthesia. Our practice prefers general anesthesia, which ensures precision of device calibration and treatment due to lack of movement during the procedure. Antimicrobial prophylaxis is given generally in the form of a first generation cephalosporin.
Segment:2 POSITIONING AND OVERVIEW.
LAUREN R. ABRAMS: The following description is for the Sonablate system. The Sonasource console has the software and Sonalink monitoring to deliver treatment.
LAUREN R. ABRAMS: The Sonasource cooling system ensures the rectal wall does not overheat. The Sonablate transducer probe delivers ultrasound treatment. The Sonachill tubing and Sonablate probe tip kit are disposable after each procedure. The patient is positioned in dorsal lithotomy and a warming blanket is applied. A Malecot catheter is inserted into the rectum and irrigated copiously with normal saline until the effluent is clear, approximately 2 liters.
LAUREN R. ABRAMS: A urethral Foley is inserted under sterile conditions. HIFU treatment times range from 1 and 1/2 to 3 hours depending on the volume of tissue being ablated. The operating room team is trained on Sonasource, probe, Sonachill setup. The HIFU probe is inserted into the rectum with ultrasound-specific jelly, and the probe is held in place by the multi-axis stepper and probe arm seen here.
LAUREN R. ABRAMS: Once the HIFU probe is secured in place, the Sonablate software can be calibrated with MRI images from prior fusion biopsy. The prostate is mapped via ultrasound and treatment area is defined. The Sonablate probe has a dual transducer with focal lengths of 3 or 4 centimeters, allowing for near, posterior, or far anterior ablation respectively.
LAUREN R. ABRAMS: Each thermal lesion is 10 to 12 millimeters in length, and 1 to 2 millimeters wide, about the size of a grain of rice. Sequentially positioned lesions comprise the treatment target area. The Sonachill system circulates cold water within the probe to cool the rectal wall and provides ultrasound coupling between transducer and tissue.
LAUREN R. ABRAMS: Rectal wall distance is continually measured between the therapy transducer and the rectal wall and reflectivity index monitor can detect undesired cavitation bubble formation at the rectal wall. During treatment planning and delivery care is taken to avoid the rectum, neurovascular bundle, and urethra. The urinary catheter is generally left in during treatment.
LAUREN R. ABRAMS: If treatment near or across the urethra as desired, the catheter must be removed. Here we have a sample focal HIFU patient who is a 51-year-old male with a PSA elevated to 4.7, and five months later was 5.7 on a recheck. He underwent a standard TRUS biopsy, which revealed a 15 gram prostate and Gleason 3 plus 4 equals 7 prostate cancer, and 6 of 6 right-sided cores.
LAUREN R. ABRAMS: All left-sided cores were negative. The patient elected HIFU with a right hemiablation plan. He underwent MRI of the prostate, which showed a 1.7 centimeter right posterior lesion extending from the base to the apex with no evidence of periprostatic disease.
Segment:3 ABLATION PLANNING.
LAUREN R. ABRAMS: Here we see that the patient's prostate has been identified on ultrasound using the HIFU Sonablate software.
LAUREN R. ABRAMS: The software uses step-by-step instructions to accurately measure the patient's prostate gland. Once MRI and ultrasound fusion is complete, we define our ablation zones to cover the target. Again, we can use our dual-sided transducer to completely capture the entire prostate and desired target zone. The most anterior tissue farthest from the probe is treated first.
LAUREN R. ABRAMS: We then select ablation sites to cover the desired portion of the ablation zone while avoiding critical structures. Once we refine our ablation plan, we are ready to proceed with anterior ablation.
Segment:4 SAMPLE ANTERIOR ABLATION.
LAUREN R. ABRAMS: We typically retreat anterior tissue, as the venous plexus can act as a heat sink preventing proper heat buildup.
LAUREN R. ABRAMS: Ultrasound waves are delivered in a treatment cycle of 3 seconds on, 6 seconds off, or conversely, with 6 seconds on and 3 seconds off. We use the slower 3 seconds on 6 seconds off cycle to prevent heat buildup in the foreground or periprosthetic adipose tissue. In this particular patient, the Foley was removed prior to treatment due to concern for medial cancer.
LAUREN R. ABRAMS: Here we see our option to increase or decrease HIFU power and toggle between treatment cycles. Again, rectal wall distance and reflectivity index are continuously monitored to ensure safety of the rectum. Ablation progress is monitored by tissue change monitoring calculations. Tissue change monitoring software assesses radio frequency signal changes within the tissues.
LAUREN R. ABRAMS: This is color-coded for the physician to interpret the degree of tissue change to guide HIFU delivery. Treatments labeled in green are considered minimal change and can be retreated. The total ablation time is typically between 30 and 60 minutes for focal or hemiablation. Once anterior treatment is complete, we reposition the probe for posterior zone treatment.
LAUREN R. ABRAMS: Here we see the patient's lesion captured within the posterior treatment zone. We refined the ablation plan. For this patient in particular, we use a hockey stick pattern extending beyond the midline to ensure adequate treatment margin. Once planning is complete, we proceed with posterior treatment. This particular hyperechoic was completed within 28 minutes in 3 seconds.
LAUREN R. ABRAMS: Our rectal wall monitoring parameters remained within a safe range throughout treatment. Treatment effect is monitored throughout the ablation and the ablation is determined to complete.
Segment:5 TROUBLESHOOTING.
LAUREN R. ABRAMS: Sonalink monitoring provides a two-way audiovisual communication by SoniCare support personnel to help guide treatment and troubleshoot any issues. Avoiding rectal wall thermal injury is imperative during treatment.
LAUREN R. ABRAMS: Clean apposition between the rectal wall and Sonablate balloon is critical. If there is any concern, the physician must pause the HIFU probe, perform a finger sweep, and perform rectal irrigation if necessary. We also ensure that the Sonachill tubing is not kinked and should feel cool on digital inspection. In general, we avoid the treatment of apical tumors. They are difficult to visualize on ultrasound, and the risk of sphincter injury and subsequent incontinence is high.
LAUREN R. ABRAMS: Hemiablation approach is preferred to minimize the risk of untreated cancer. The treatment boundaries are from base to apex, anterior to posterior capsule, and then from the lateral capsule to the urethra. A 1-centimeter treatment margin as preferred. Treatment across the urethra requires catheter removal and replacement at the end of the case. Few to no side effects are seen when treatment is applied along less than 50% of the urethral length.
LAUREN R. ABRAMS: After completion of HIFU ablation, patients are discharged home the same day. Their Foley catheter is removed at home or in the office postoperatively on day 3. Alpha blockers such as tamsulosin and antibiotics are prescribed for 5 to 7 days postoperatively. Generally, patients return to the urologist office two to three months after treatment for a clinical evaluation and the first-post treatment PSA.
LAUREN R. ABRAMS: Ideally a six-month post treatment MRI fusion biopsy is performed to confirm treatment effect. For our sample patient, his PSA went from 5.7 preoperatively to 0.46 postoperatively. His MRI showed post-operative changes of right HIFU without evidence of recurrent or residual disease. On post-treatment biopsy, all 12 cores were negative for cancer.
Segment:6 CLINICAL OUTCOMES.
LAUREN R. ABRAMS: The ideal focal HIFU patient has unilateral localized intermediate risk prostate cancer.
LAUREN R. ABRAMS: Our group recommends HIFU as an extension of active surveillance rather than definitive treatment. This means that patients must be maintained on a followup protocol consisting of routine clinical exams and PSAs. Ideally, we'd like to have followup MRIs and post-treatment biopsies. We progress patients to radical therapy if any concerning findings such as biochemical recurrence, abnormal DRE, or clinically significant cancer on a post-treatment biopsy.
LAUREN R. ABRAMS: A recent United States series of 100 men who underwent hemigland ablation showed a two-year failure-free survival rate of 73% of patients. Radical treatment was avoided in 91% of men at two years. Median time to PSA nadir was three months with a median PSA reduction of 75%. 65% of these patients underwent a followup prostate biopsy, in which 18 patients were found to have clinically significant prostate cancer, with 8 in-field recurrences and 10 out-of-field recurrences.
LAUREN R. ABRAMS: The most common complications of focal HIFU ablation include debris in the urine, dysuria, lower urinary tract symptoms, urinary tract infection, and urinary retention. A Foley catheter postoperatively helps mitigate the risk of retention due to urethral swelling. A subset of patients may also experience epididymo-orchitis, hematuria, or hematospermia. Long-term effects include retrograde ejaculation and anejaculation.
LAUREN R. ABRAMS: Minimal and self-limited erectile function changes occur in 10% to 20% in our experiences. Rare complications include loss of erections, urinary incontinence, urethral stricture, and rectourethral fistula. A systematic review of 13 studies and 346 men having undergone focal HIFU ablation demonstrated the probability of secondary local treatment was 7.8%. Overall and disease-specific survival were both 100%.
LAUREN R. ABRAMS: Significant adverse effects occurred in 1 and 1/2% of patients. Pad-free continence was demonstrated in 100% of patients, and potency preservation in 88.6% of patients. Another systematic review summarized the functional outcomes of patients undergoing focal HIFU therapy. Postoperative rectourethral fistula was reported in only one patient, and there were no reported deaths.
LAUREN R. ABRAMS: Definitions of erectile dysfunction and urinary incontinence varied greatly by study. A table summarizing several studies looking at focal HIFU ablation and the oncologic and functional outcomes can be found in the manuscript associated with this video. Briefly, HIFU has a role in the salvage setting in patients with the PSA less than 10, biopsy-proven cancer in the prostate, with staging imaging negative for metastatic disease.
LAUREN R. ABRAMS: The rectal wall can be scarred and thicker in patients who have undergone radiation, so additional caution must be taken to avoid rectal injury. We use the slow treatment cycle and we do not recommend post-treatment biopsy after salvage HIFU. Multiparametric MRI alone has been shown to have a low sensitivity, around 44%, for detection of clinically significant prostate cancer recurrence after HIFU.
LAUREN R. ABRAMS: Preliminary studies show encouraging data that positron emission tomography with a radiotracer targeting prostate-specific membrane antigen can be used to localize recurrent disease after HIFU. In conclusion, high-intensity focused ultrasound ablation is an exciting new technology in the focal treatment of primary intermediate risk prostate cancer and post-radiation salvage treatment. Urologists must carefully consider each individual patient's age, comorbidities, disease characteristics, and goals of treatment.
LAUREN R. ABRAMS: Further studies are warranted to investigate the long-term oncologic and functional outcomes associated with high-intensity focused ultrasound ablation of the prostate.