eMedicine Specialties > Urology > Cancer, Prostate
Prostate Cancer - Cryotherapy: Treatment
Updated: Apr 27, 2009
Treatment
Medical Therapy
A large prostate volume (>50 cm3) can lower the technical feasibility of complete cryoablation. For example, neoadjuvant androgen ablation with a 3-month depot injection of a luteinizing hormone–releasing hormone agonist usually reduces the prostate to 60-70% of its original size. Androgen ablation may also reduce the tumor burden in patients with stage T3 disease (ie, gross extracapsular extension or seminal vesicle involvement).
In the setting of interstitial radiotherapy (brachytherapy), neoadjuvant androgen ablation has indeed been shown to effectively reduce prostate size, although it does not affect oncologic outcomes but does diminish quality-of-life outcomes, particularly in terms of potency rates.30,31 Neoadjuvant androgen ablation has not been prospectively evaluated in the context of cryotherapy; however, in a subset analysis of retrospective series, it has not been shown to improve outcomes.32 Indeed, in one large analysis, subjects receiving neoadjuvant therapy had worse biochemical outcomes than those receiving cryotherapy alone, although those in the neoadjuvant group also had more aggressive tumor characteristics on average.33
Surgical Therapy
Patients at high risk for lymph node metastasis who are contemplating cryosurgery but have negative findings on cross-sectional imaging studies may undergo regional lymphadenectomy, as identification of lymph node metastases is a relative contraindication for aggressive local therapy for prostate cancer. Lymphadenectomy may be performed laparoscopically or via a minilaparotomy with low morbidity. Significant risk factors for lymph node metastases, such as a PSA level of more than 20 ng/mL or a Gleason score of 8-10, predict failure after any local treatment, even if resected lymph nodes prove to be free of disease.
Preoperative Details
Before cryotherapy is performed, patients undergo a light bowel preparation consisting of oral magnesium citrate on the day before treatment and an enema the morning before treatment.
Intraoperative Details
Cryosurgery may be performed with the patient under general or regional anesthesia. After anesthesia is induced, the patient is placed in a lithotomy position. A Councill-tip urethral catheter is placed, and the bladder is distended with saline to displace the peritoneal contents from the treatment area. A TRUS probe is inserted into the rectum, and the anatomic configuration of the prostate and tumor, if ultrasonically identifiable, is confirmed.
Until recently, cryotherapy technique used relatively large cannulae requiring prior tract dilation. Hollow, diamond-tipped, 18-gauge needles were placed into the prostate transperineally under TRUS guidance. Six needles were placed bilaterally in the anteromedial, posterolateral, and posteromedial regions. (All needles must be placed at least 8 mm from the urethra.) Once all needles were positioned, each was passed with a 0.038 J-tip guidewire to the proximal extent of the prostatic capsule, after which the needle was removed. The tract was then dilated over the wire, a 12F cannula was placed, and the wire was removed.
Modern third-generation cryotherapy systems (eg, Galil [Galil Medical USA; Woburn, Mass], CRYOcare [Endocare; Irvine, Calif]) use smaller, needle-shaped probes, which can be placed percutaneously, directly into the prostate without dilation. Up to 30 such probes may be placed to achieve a more uniform freezing pattern, as is displayed in the image below.9,16 In the future, computer software systems currently under development will most likely facilitate both preoperative planning and real-time monitoring of progression of therapy.34
Example of third-generation prostate cryotherapy setup, illustrating urethral warming catheter, 2 percutaneous temperature probes, and 3 cryotherapy probes. (This case was a salvage case of focal treatment for an ultrasonographically visible lesion, so only 3 cryoprobes were required.)
Thermosensors are placed, as shown below, either through additional 18-gauge needles or via direct puncture, to monitor the temperature at the apex, at the external sphincter, along the Denonvilliers aponeurosis, and at the edge of the tumor. The Councill-tip urethral catheter is exchanged over a guidewire for a urethral warmer. Warm saline irrigation is started through the warmer.
Transrectal sonogram of the prostate illustrating placement of the cryoprobes and urethral-warming catheter.
With modern cryotherapy systems, each cryoprobe may be fixed in place by freezing each to -10°C to create a small ice ball; this step may be omitted if a perineal template is used. Ice within the prostate casts a dense acoustic shadow, obscuring all anatomic detail anterior to the ice; therefore, the anterior probes must be activated first.
Transrectal sonogram of the prostate during cryoablation. The leading edge of the ice ball, growing posteriorly, is echodense and casts a dark acoustic shadow anteriorly.
The anterior ice balls are extended posteriorly and laterally, including a 2- to 4-mm margin into the lateral periprostatic tissues and beyond the apex. If tumor extracapsular extension is suspected, the ice is propagated further laterally on the involved side. In addition to continuous TRUS monitoring, the thermosensors are monitored to ensure that the target tissue temperature is reduced uniformly to at least -40°C to ensure complete tissue necrosis. Recent in vitro data suggest that the rapidity of freezing increases cytotoxicity within the ice ball margin and reduces damage beyond it.35
Diagram illustrating dimensions of a typical ice ball as seen end-on (left) and from the side (right).
The anterior probes are then thawed with helium, and the posterior probes are activated. The posterior ice balls are extended into, but not beyond, the rectal muscularis propria. If the apex is inadequately frozen, the probe may be withdrawn toward the apex and reactivated. If seminal vesicle involvement is considered likely, an additional probe may be placed into the seminal vesicle. Two freeze-thaw cycles are performed; 2-cycle therapy has been proven in vivo to result in more complete coagulative necrosis than a single cycle and achieves killing at a critical temperature of -41°C (-41.8°F) rather than the -62°C (-79.6°F) required for a single cycle.36
Transrectal sonogram illustrating the ice ball now extending posteriorly to the muscularis propria of the rectum. All prostate tissue is now included within the margin of the ice ball.
After the second cycle, the cryoprobes and/or cannulae are removed, and, if large-bore cannulae were used, the perineal insertion sites are closed with 4-0 chromic suture. The urethral warmer remains in place until all thawing is complete; it is then exchanged for a Foley catheter, or a suprapubic tube is placed.
The following technical measures were explicitly recommended by the AUA Best Practice Statement panel:12
- Use of rapid freezing for better tissue destruction
- Use of thermocouples for temperature monitoring
- Freezing to -40°C
- Use of passive (slow) thawing
- Use of a double freeze-thaw cycle
Postoperative Details
Cryotherapy is usually performed in an outpatient setting. A urethral catheter is left in place for 3 weeks following treatment to minimize the likelihood of tissue sloughing and urinary retention. Urinary retention after cryotherapy is quite common because of local urethral edema. Some investigators have reported leaving the urethral warming catheter in place for several hours after the procedure in an attempt to minimize injury to the urethra,37 but this maneuver has not been well studied.
Follow-up
Routinely evaluate the patient after cryotherapy to assess for the development of late complications and to assess for symptoms or signs of clinical recurrence. Monitor the PSA level at regular intervals.
For excellent patient education resources, visit eMedicine's Prostate Health Center and Cancer and Tumors Center. Also, see eMedicine's patient education article Prostate Cancer.
Complications
Cryotherapy impairs the penile arterial blood supply38 and damages the cavernosal nerves responsible for erectile function.39 This combined neurovascular insult results in impotence in 40-100% of treated patients,40 depending on such factors as the use of multiple freeze-thaw cycles, the size of the ice ball generated, preoperative potency, the instruments used to assess potency, and the follow-up interval since treatment. Greater nerve regeneration is possible after cryotherapy than after surgery or radiation therapy; accordingly, some patients have reportedly recovered erectile function up to 2 years after treatment. One report indicated that 95% of subjects who were potent before cryotherapy became impotent and that 5% regained their potency at a mean of 16 months.40
A pooled analysis of 975 patients treated at 5 institutions from 1993-1998 revealed an impotence rate of 93%.33 However, another report indicated that, 3 years after cryoablation, 5 (13%) of 38 subjects had regained potency and 13 (34%) were potent with the help of erectile aids.41 In a large recent series, Jones et al noted that, of patients potent at the time of therapy (29.5% of the cohort), only 25% returned to intercourse posttreatment, and only 8.8% without the use of medications or other assistance.42
Aggressive penile rehabilitation has a growing place in the management of erectile function after prostatectomy and may also have a role after cryotherapy. For example, Ellis et al reported that a penile rehabilitation program resulted in recovery of erectile function following cryotherapy in 41% of patients at 1 year and 51% at 4 years.43 Nonetheless, postprocedural potency is the quality-of-life domain for which cryotherapy remains clearly inferior to other local treatment modalities for prostate cancer. Until the return-of-potency rate improves, the risk of impotence will likely continue to be an impediment to wider use of cryotherapy among patients in whom erectile function is important.
One group of investigators has studied a method of nerve-sparing cryotherapy in a canine model by using active helium-based warming of the neurovascular bundles during freezing of the prostate. Unfortunately, nerve preservation was not completely reproducible; moreover, the warming also resulted in incomplete ablation of prostatic tissue adjacent to the nerves.44
Incontinence
As with impotence, reported rates of incontinence depend greatly on the definitions of continence and the methods of assessment. These rates vary from 4%45 to 27%46 in patients undergoing cryotherapy as primary treatment. Among the largest single series of patients who underwent primary cryotherapy, 4.3% required at least one urinary pad per day, and 11.6% had lesser degrees of incontinence40 ; Long et al reported a 7.5% incontinence rate.33
Among patients undergoing cryotherapy for salvage treatment after failure of radiation therapy, the prevalence of incontinence is higher, ranging from 7.9%47 to 95.5%,48 with rates of 20%23 to 73%18 in the largest series. In the Chin et al study, one third of the patients reporting incontinence had near-total or total incontinence.23 In a recent review of complications of cryotherapy, the rates of incontinence among patients treated with modern technique and equipment were estimated to be 5% for primary therapy and 10% for salvage therapy.49
Tissue sloughing
Cryosurgery induces necrosis in the treated prostate tissue. If the urethra freezes during treatment, its mucosal barrier fails, thus exposing the necrotic prostate tissue to the urinary tract and a risk of infection. This tissue may then slough into the urethra (typically, 3-8 wk posttreatment), producing irritative and obstructive voiding symptoms, pyuria, and, possibly, urinary retention. The use of urethral warming devices significantly reduces the risk of this complication. One series reported a reduction from 85% to 37%.50 In another report, urethral warming reduced the rate of sloughing causing obstruction from 54% to 14%.51
Data from a pooled analysis likewise revealed obstruction requiring TURP in 10% of patients undergoing urethral warming via an approved catheter versus 44% in other patients.33 In contemporary series, the overall rate of sloughing has ranged from 3.8-23% in patients receiving primary cryotherapy52,53,54 and from 5-44% in those undergoing salvage treatment.18,37 In a recent large series of salvage cryotherapy, transurethral resection of sloughed tissue was necessary in 3.2% of patients.55
Conservative treatment includes antibiotics and urinary drainage; continuous intermittent self-catheterization may help dislodge obstructing tissue. In some cases, transurethral removal or resection of necrotic tissue may be required. Nearly 50% of patients requiring transurethral resection after cryotherapy develop incontinence14 ; therefore, resection must be as limited as possible.
Pelvic and rectal pain
One to 11% of patients receiving primary cryotherapy56,46,54 and 21-77% of those receiving salvage therapy for radiation failure48,18 report pelvic and/or rectal pain. The etiology of this pain is unclear but may include rectal wall ischemia, freezing of the pelvic floor musculature and/or pubic bone, or extravasation of urine into the periprostatic tissues. Urinoma or abscess must be excluded in these patients. The pain is best managed with anti-inflammatory medications.
Penile numbness
In early studies, approximately 10% of patients treated with cryotherapy developed penile numbness attributable to injury to the dorsal nerve of the penis. This injury was attributed to cryotrauma to the pudendal nerve associated with excessive freezing of the anterior probes. This complication was usually temporary, resolving spontaneously in approximately 2-3 months.14
Rectourethral fistula
Complete freezing of tissues posterior to the prostate, with urinary extravasation and possible subsequent infection, can lead to fistula formation, which is reported in 0%52,57 to 3%46 of primary cryotherapy patients. In their series of 590 cases, Bahn et al reported only 2 cases of fistula formation40 ; Long et al, likewise, reported a 0.5% rate of fistula formation among 975 patients,33 and Jones et al reported a 0.4% rate among 1198 patients who underwent cryosurgery as primary therapy.42 Rates may be higher among salvage patients—up to 11% in one report.57 In one large series of salvage cases, however, only 4 cases were reported among 118 patients23 ; among 279 salvage patients recently reported, the fistula rate was 1.2%.55Rectourethral fistula may not develop until several months after treatment. Patients typically present with watery diarrhea or pneumaturia. Diagnosis is confirmed with voiding cystourethrography or CT scanning. Conservative treatment consists of Foley catheter drainage, possibly facilitated by fistula tract fulguration. Any formal fistula repair (eg, a repair involving a muscle transposition flap) should be delayed 4-6 months to allow the inflammatory process to subside and should involve a multidisciplinary approach that includes colorectal surgeons and urologists.49
Urethral stricture results from extensive tissue sloughing, usually at the bladder neck. This is a rare complication when urethral warming is used and can usually be successfully managed with transurethral incision or balloon dilation.
Hydronephrosis, attributed to cryoinjury of the ureteral orifice or distal ureter as a result of deep seminal vesical or bladder neck freezing, has been reported in 0-36% of subjects undergoing salvage cryotherapy for recurrence after radiotherapy.48,18 This complication can usually be avoided by careful TRUS monitoring of the trigone and ureteral orifices during treatment.
Small-bowel obstruction
In one series, only 1 of 176 subjects developed a bowel obstruction following cryotherapy. This result was attributed to ice-ball extension into the peritoneal cul-de-sac. Such extension is usually preventable by identification of the cul-de-sac on TRUS images and by distention of the bladder before the procedure in order to displace the peritoneal contents.32
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References
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Further Reading
Keywords
cryotherapy, prostate cancer, cryoablation, cryosurgery, cryoprobes, urethral warming catheters, brachytherapy, radiotherapy, radiation therapy, radical prostatectomy, systemic androgen deprivation therapy, transrectal ultrasound, TRUS, transurethral resection of the prostate, TURP, transurethral cryoablation, pelvic lymphadenectomy, neoadjuvant androgen ablation, prostate-specific antigen, PSA, benign prostatic hyperplasia, BPH, erectile dysfunction, ED, impotence, potency, incontinence, continence, penile numbness, rectourethral fistula, urethral stricture, hydronephrosis, small bowel obstruction
