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Prostatic cryotherapy


Cryotherapy for localised Prostate Cancer

Advances in cryoablative technology in the past decade have allowed more efficient freezing of the prostate gland while reducing damage to surrounding tissues, notably the rectum, urethra and external urinal sphincter.

The morbidity associated with this treatment alternative has become comparable with that of other available treatment options due to the development of transrectal ultrasound guidance, urethral warmers, and liquid nitrogen to gas driven probes and a transition from cryoprobes to the smaller cryoneedles.

The availability of PSA testing has allowed for better patient selection and monitoring of cancer control following treatment.

Seednet Gold Cryotherapy System

The first for Australia to the Prostate Cancer Institute.

Through the support of the NSW Cancer Institute, the first Cryotherapy System in Australia will be allocated to the Prostate Cancer Institute. It completes the provision of all state-of-the-art treatment options for men with prostate cancer.

The Cryotherapy system provides urologists with a safe and effective, minimally invasive treatment for prostate and renal cancers.

Today, minimally invasive treatments are in demand. Thanks to advanced imaging and innovative medical device advances, such treatments are more accessible.

The Cryotherapy system when used in combination with temperatures and image monitoring has resulted in safe and effective outcomes for prostate cancers.

•  It is simple to perform – a true minimal invasive procedure

•  Patients are discharged from the hospital in 24-48 hours

•  Procedure is demonstrated to have minimal blood loss

•  Very low incidence of co-morbidities

•  Excellent clinical results

•  Minimal trauma

The machine

The development of third generation cryoablation included gas-driven 17 gauge (1.47mm) cryoneedles use the Joule-Thompson principle in which different gases undergo unique temperature changes when depressurised – according to unique gas coefficients – so pressurised gas can be used to both freeze (argon gas) and actively thaw (helium gas) the prostate.

The cryoablation device for prostate cancer treatment available in Australia is the SeedNet system established through Oncura. The system utilises pressurised argon gas as the cryogen and up to 25 cryoneedles can be used to create a conformal freezing pattern.

The ultra thin cryoneedles allow for direct transperineal needle placement through a brachytherapy-like template without making incisions or using tract dilatation and insertion kits. The iceball created by the Oncura system is approximately 2cm in diameter.

Patient selection

There are three indications for prostate cryoablation: primary therapy, salvage therapy and palliation.

In general, it is recommended cryoablation for patients with localised, high-grade tumours and higher-volume disease who are not potent or not interested in maintaining their potency.

Cryoablation is also a reasonable therapeutic option for the following patients:

•  those with clinically locally advanced disease (stage T3)

•  those with no evidence of metastatic disease with a grade or stage of the disease likely to progress without treatment (Gleason score of 6 and stage greater than A1/T1a

•  those who are poor candidates for radical prostatectomy (eg, because of Crohn's disease, ulcerative colitis, weight greater than 150kgs, cardiac disease etc.)

•  and patients who have no evidence of metastatic disease with less than 10 year life expectancy who, after reviewing available information on prevailing therapeutic options for new diagnoses of prostate cancer, are unsatisfied with or refuse to undergo radical prostatectomy or radiotherapy.

Local cancer recurrence following radiation therapy (external beam or brachytherapy) may be managed with cryoablation.

Cryoablation has also been used to treat local recurrences following radical prostatectomy. Patients with locally progressive disease despite hormonal manipulation can be treated with cryoablation to prevent urinary obstruction or bleeding.

Patients with high risk of metastatic disease should undergo imaging, radionuclide bone scan or cross sectional imaging of the abdomen and pelvic based on stage and grade, as well as serum PSA. Patients at high risk for lymph node metastases may undergo regional lymph node dissection. Patients with gross extracapsular extension or seminal vesicle invasion are treated with neoadjuvant hormone therapy to reduce the tumour volume and allow for better inclusion within the iceball.

Surgical Technique

Patients are placed in an exaggerated dorsal lithotomy position with careful cushioning.

The perineum is placed slightly over the operating table edge at 90 degrees to the operating room floor to permit access to the TRUS probe-holding device and template (figure 1).

The patient is shaved and prepped from the perineum to the umbilicus. The scrotum is fixed superiorly using two stay sutures. A 16F Foley catheter is inserted and clamped to allow the bladder to distend.

A multifrequency biplanar TRUS probe is attached to the holding device adapting cradle of the brachytherapy stepper and is used to image the prostate and measure its dimensions, the aiming grid software may be activated and projected on the TRUS image.

The attached probe is lowered posteriorly until slight resistance from the posterior rectal wall is felt or the image of the shiny anterior fibromuscular stroma is lost at 5MHz. This manoeuvre opens up the distance between the prostate gland and the rectum. This prevents rectal wall ischemia during freezing and increases the safety of the procedure.

Once the adjustments are completed, the holding device is fixed in place. A brachytherapy-like template drilled with a matrix of 17-gauge holes is attached to the holding device and gently fixed against the perineum. The holes in the template are 5mm apart and correspond to the aiming grid projected on the ultrasound image.

The 17-gauge cryoneedles are inserted under TRUS guidance, each spaced about 1cm apart until 12 to 20 cryoneedles are placed to outline the shape of the prostate. Cryoneedles are inserted in either three horizontal layers or four layers about 1cm apart. Each layer groups two to five cryoneedles according to prostate width (figures 2a & 2b).

Since the iceballs progress longitudinally 5mm past the needle tip, the needles are advanced into the prostate base and positioned 5mm caudal to the bladder neck. The most posterior layer is ideally located 5-7mm anterior to the prostate capsule,

The prostatic urethra is identified by TRUS in both the longitudinal and transverse views, and the cryoneedles are placed about 1cm away from the urethra. The only cryoneedle permitted in the sagittal plane as the urethra is the middle probe of the posterior layer when an uneven number of probes are used.

In patients undergoing salvage cryoablation, some degree of fibrosis may be encountered during placement of the needles. The gland may be adherent to the anterior rectal wall due to the previous radiation, diminishing the thickness of the Denonvilliers' fascia.

After all the cryoneedles have been positioned, the Foley catheter is gently removed.

A .038-inch guide wire is inserted through the working channel of the cystoscope, which is then withdrawn, and a heavily lubricated urethral warming catheter is introduced into the bladder over the guide wire. The urethral warmer is a closed double-lumen catheter made of a polyethylene membrane in which saline heated to 43 degrees celcius is continuously circulated through it by a water pump. During the procedure, the bladder is kept nearly full to prevent injury from the rigid tip of the warmer device.

TRUS visibility

To maintain TRUS visibility, the freezing is started at the anterior probe layer and continued posteriorly, Uncovered areas may be visualised and a correcting manoeuvre may be used.

On TRUS, frozen tissue is significantly different from unfrozen tissue in sound impedance, resulting in strong echo-reflection at the interface of frozen and normal tissue. The leading edge of the frozen tissue is seen as a bright line (figure 3). The tissue inside is concealed in the acoustic shadow created by this boundary. Therefore the anterior boundary of the freezing area cannot be monitored. The refraction and reflection of the sound wave can also over estimate the lateral boundary of the iceball.

Two 10-minute freezing cycles are performed/ between the cycles, the prostate may be allowed to thaw passively (15 to 20 minutes) or actively using helium (7 to 8 minutes).

The Seednet cryoneedles provide 27mm long, -20dgrees celcius isotherm at 10 minutes of continuous freezing.

To ensure adequate cancer treatment, the iceball is often allowed to extend 2 to 4 mm laterally into the periprostatic tissues, beyond the apex, and into the muscularis propria of the rectum posteriorly. In areas of extracapsular cancer extension, greater propagation of the iceball is permitted laterally, and if necessary, an additional cryoneedle may be placed in such areas.

After completing the freeze-thaw cycles, the urethral warmer is left in place for up to 5 minutes to minimise the risk of urethral sloughing and subsequent urinary retention and irritative voiding symptoms.

The cryoneedles are then removed and pressure is applied to the perineum for 2 to 5 minutes. The urethral warmer is removed, and a Foley catheter is inserted afterwards.

Patients are discharged on the same day or on postoperative day one with antibiotics, oral pain medications, an alpha-blocker maintained for at least a month and a Foley catheter to be removed in 2 to 3 days.

Patients are followed up with a clinical examination and serial PSA measurements at 3 monthly intervals. Immediately after the operation, PSA rises to a very high value due to the release of intracellular PSA from cellular necrosis. PSA nadie is usually achieved in 3 months.

Cryoablation of the prostate appears to have a low overall morbidity comparable with other available treatment options and is effective in eradicating primary and radio recurrent tumours.