|MP 7.01.79||Cryoablation of Prostate Cancer|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/5:2014
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Cryoablation, also known as cryotherapy or cryosurgery, of prostate cancer is a technique in which cryoprobes are inserted percutaneously into the prostate gland to rapidly freeze and thaw tissue causing necrosis. While most studies use total cryoablation, subtotal cryoablation is an emerging technique.
Cryoablation is one of several methods available to treat clinically localized prostate cancer and may be considered an alternative to radical prostatectomy or radiation therapy. It also may be used for salvage of non-metastatic relapse following initial therapy for clinically localized disease. Using percutaneously inserted cryoprobes, the glandular tissue is rapidly frozen and thawed such that tissue necrosis follows. Cryosurgical ablation is less invasive than radical prostatectomy and recovery time may be shorter. While external-beam radiation therapy (EBRT) requires multiple treatments, typically only one treatment is required for cryoablation.
Subtotal prostate cryoablation is also being evaluated as a form of more localized therapy (referred to by some as focal or organ-preserving therapy or male lumpectomy) for small localized prostate cancers.
Cryoablation of prostate cancer uses available cryoablation systems and, as a surgical procedure, is not subject to regulation by the U.S. Food and Drug Administration (FDA). A number of cryoablation systems and cryoprobes have general surgical FDA 510(k) marketing clearance. Examples of cryoablation devices that specifically mention treatment of prostate cancer in their marketing clearance are 2 Endocare® Inc. devices, Cryocare CS® and Cryocare CN2® systems, and 2 Galil Medical devices, Visual-ICE® Cryoablation System and IceRod® CX Cryoablation Needle.
Cryoablation of the prostate may be considered medically necessary as treatment of clinically localized (organ-confined) prostate cancer when performed
- As initial treatment or
- As salvage treatment of disease that recurs following radiation therapy.
Subtotal prostate cryoablation is considered investigational in the treatment of prostate cancer.
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.
This policy was originally created in 2001 and was updated regularly with searches of the MEDLINE database. The most recent literature review was performed for the period of March 2013 through April 25, 2014.
Primary Prostate Cryoablation
This policy was initially based on a 2001 TEC Assessment focused on cryoablation for primary treatment of clinically localized prostate cancer. (1) The TEC Assessment arrived at the following conclusions:
- No studies compared outcomes of cryoablation to outcomes of radical prostatectomy or conformal external-beam radiotherapy in randomized or otherwise similar patient populations. In addition, follow-up times were limited to 2 years or less in most cryoablation studies. Available studies reported only surrogate outcomes: prostate-specific antigen (PSA) and biopsy failure rates, and rates of second treatment.
- Of 34 studies reporting efficacy outcomes after prostate cryoablation, only 6 (total n=2,352) met the TEC Assessment’s inclusion criteria. Problems with available evidence included short follow-up times, heterogeneous patient populations, and insufficient information on baseline characteristics of enrolled patients. Where data were available, outcomes appeared to be generally comparable across treatment methods. However, data from cryoablation studies were sparse, and comparison of patient populations that may have had different risk distributions, both within and across treatment methods, did not permit conclusions.
- One study presented a retrospective comparison of data from the CaPSURE [Cancer of the Prostate Strategic Urologic Research Endeavor] database, a longitudinal observational database of patients with prostate cancer. Adjusted overall rates of second treatment indicated that patients receiving cryoablation were 1.9 times more likely to have a second treatment than patients who received radical prostatectomy, and 1.4 times more likely than patients who received external-beam radiotherapy (EBRT). When rates of second treatment were stratified by prognostic factors, the rates for cryoablation compared to those for radical prostatectomy tended to be significantly increased for low-risk disease but not for high-risk disease. The same was true for EBRT compared to radical prostatectomy, but to a lesser extent. Thus, these results did not suggest an advantage for cryoablation and may have indicated poorer outcomes for low-risk disease.
- Perioperative mortality and acute life-threatening consequences of cryoablation appeared to be negligible. Patients had the highest likelihood of impotence after cryoablation, compared to radical prostatectomy or 3-dimensional conformal radiation therapy (3D-CRT). The frequency of incontinence appeared similar to that after 3D-CRT, and potentially less than that after radical prostatectomy. However, other genitourinary complications were unique to cryoablation. Adverse gastrointestinal consequences typical of 3D-CRT were not noted after cryoablation. Long-term consequences of cryoablation were uncertain because follow-up was inadequate.
The conclusions of the 2001 TEC Assessment contrasted with an analysis from the Centers for Medicare and Medicaid Services (CMS) supporting Medicare’s decision that cryosurgical ablation is eligible for coverage. (2) While the TEC Assessment sought data on health outcomes, the CMS assessment used an intermediate outcome, changes in PSA levels. As noted in the CMS assessment, “Data shows that a significant number of patients are able to sustain undetectable levels of PSA for a period of time of at least 24 months. This compares favorably with the biopsy data following external beam irradiation.”
A 2007 Cochrane review of cryoablation for localized prostate cancer found no randomized trials comparing cryoablation with other therapies for primary treatment of localized prostate cancer. (3) Studies identified were case series. The patients recruited (n=1,483) ranged in age from 41 to 84 years, and their conditions were classified by stage: stages T1: 0 to 43%, T2: 24% to 88%, T3: 1% to 41%, and T4: 0 to14%. The mean preoperative prostate-specific antigen (PSA) level ranged from 9.7 to 39 ng/mL, with Gleason scores less than 7 and ranging from 6% to 37%. The authors concluded the following: cryoablation offers a potential alternative to standard therapies for the primary treatment of localized prostate cancer; however, the poor quality of the available studies makes it difficult to determine the relative benefits of this modality; patients selecting cryoablation as their therapeutic option should be made fully aware of the reported efficacy, complications, and low-grade evidence from which these data are derived.
A 2008 comparative effectiveness review of therapies for clinically localized prostate cancer from the Agency for Healthcare Research and Quality (AHRQ) also found that no randomized trials had evaluated cryoablation. (4) The report also noted that in general neither overall survival (OS) nor prostate-cancer-specific survival was reported for this technique. Progression-free survival (PFS) in patients with T1–T2 stages ranged from 29% to 100%.
In October 2011, a systematic review of localized prostate cancer treatments prepared for AHRQ to update the 2002 U.S. Preventive Services Task Force Recommendation was published. (5) The review found no studies comparing cryoablation with watchful waiting and no randomized trials or cohort studies evaluating OS or prostate cancer-specific mortality outcomes. The available evidence was mostly from uncontrolled studies and found to be very limited and not sufficiently reliable to estimate the benefits or harms of cryoablation.
In a 2012 comparative effectiveness report from the international Prostate Cancer Results Study Group (PCRSG), PSA-free survival following various prostate cancer treatments, including cryoablation, was noted to be difficult to evaluate, since very few studies comparing results from treatment options were identified. (6) Additionally, variations in methods of evaluating outcomes and reporting results complicated the analysis. No recommendations for cryoablation were made by the PCRSG.
Randomized, controlled trials
Chin and colleagues reported on a randomized trial of cryoablation compared to EBRT in patients with clinical stage T2C-T3B prostate cancer. (7, 8) These patients had node-negative disease and also received 6 months of hormonal therapy, starting 3 months before treatment. Only 64 of the planned 150 patients were accrued; entry was limited due to changes in practice and difficulty beginning cryosurgery at one of the sites. Twenty-one of 33 (64%) in the cryoablation group and 14 of 31 (45%) in the EBRT-treated group were classified as treatment failure. The mean biochemical disease-free survival (bDFS) was 41 months for the EBRT group compared to 28 months for the cryoablation group. The 4-year bDFS for EBRT and cryoablation groups were 47 and 13%, respectively. (7) The 8-year bDFS for EBRT and cryoablation groups were 59.1% and 17.4%, respectively. Disease-specific survival (DSS) and OS for both groups were very similar and at 8 years’ follow-up, were not significantly different. (8) Serious complications were uncommon in either group. EBRT patients exhibited adverse gastrointestinal (GI) effects more frequently. The authors concluded that taking into account the relative deficiency in numbers and the original trial design, this prospective randomized trial indicated that the results of cryoablation were less favorable compared to those of EBRT and that cryoablation was suboptimal primary therapy in locally advanced prostate cancer.
Donnelly and colleagues reported on a randomized trial of 244 patients with newly diagnosed localized prostate cancer, during the period of December 1997 through February 2003, to compare cryoablation to EBRT. (9) All patients began neoadjuvant antiandrogen therapy prior to local treatment and continued for a period of 3-6 months. Median follow-up was 100 months. At 36 months, the biochemical failure rate (PSA nadir + 2 ng/mL) was 17.1% in the cryoablation group versus 13.2% in the radiotherapy group. Overall survival at 5 years was 89.7% in the cryoablation group versus 88.3% in the radiotherapy group and did not differ statistically (p=0.78). At 36 months, radiotherapy patients had significantly more positive prostate biopsies than the cryoablation group (22 of 76 vs. 7 of 91 patients, respectively [p<0.001]). Observed failure rates at 60 months were equal in both groups but favored cryoablation at 84 months. Twelve cryoablation patients experienced 13 grade 3 adverse events versus 16 grade 3 adverse events in 14 radiotherapy patients using National Cancer Institute of Canada Common Toxicity Criteria. Urinary retention was the most common grade 3 adverse event in both treatment arms. The authors indicated they were unable to establish that cryoablation was noninferior to radiotherapy at 36 months due to the wide confidence interval. However, they noted several issues which limit interpretation of the study results, including the use of lower radiation dosages (68 Gy, 70 Gy, and 73.5 Gy, respectively) than are common today and early trial closure due to lack of patient enrollment.
In a second article from the Donnelly study, (9) Robinson et al. reported on quality-of-life (QOL) outcomes in the same 244 patients. (10) With only a few exceptions, the authors found study participants reported QOL at high levels in both the cryoablation and radiotherapy treatment arms. Acute urinary dysfunction, which eventually resolved, occurred more often with cryoablation, as measured using the University of California at Los Angeles (UCLA) Prostate Cancer Index (mean urinary function in cryoablation was 69.4 vs. 90.7 in EBRT; p<0.001; higher scores meaning better function and less bother). UCLA Prostate Cancer Index sexual function decreased in both arms at 3 months. However, reduced sexual function was reported more in the cryoablation arm (mean cryoablation: 7.2 vs. 32.9 in EBRT; p<0.001). Decreased sexual function continued at the 3-year evaluation with the mean score 15 points lower in the cryoablation group.
Nonrandomized, comparative studies
Many nonrandomized studies have reported on cryoablation for localized prostate cancer. (11-20) While some, but not all, studies collected data prospectively in consecutive patients, none included a concurrent comparison group treated with an established alternative. In addition, it was unclear whether “consecutive” meant patients meeting eligibility criteria or those consenting to enroll in a study. Furthermore, retrospective comparisons used historical data collected using different guidelines to assign risk groups or monitor for recurrence (e.g., frequency of follow-up PSA measurements and PSA thresholds for recurrence). The largest single institution series reported the 7-year actuarial rate of biochemical disease-free survival (bDFS) of 590 consecutively treated patients. (11) However, 59% of the patients were treated using an older, liquid nitrogen system, which the authors asserted “… yields inferior results compared with the argon-based cryomachines we now use….” Even so, reported results combined outcomes obtained with both systems.
Aus reported that cryoablation is now using third-generation equipment and that long-term follow-up from these devices, which emerged around 2000, will be needed. (21) These newer devices use more ultrathin probes and argon gas (as opposed to liquid nitrogen) and create smaller ice balls. Lian and colleagues reported early results of cryoablation using third-generation technology as primary treatment for 102 patients with localized prostate cancer during the period of 2006 through 2009. (22) Only one patient developed biopsy-confirmed prostate cancer recurrence. PSA levels were elevated in 7 patients; however, biopsies were negative. Mild incontinence, urethral sloughing, and erectile dysfunction occurred in 4%, 4.9% and 64%, respectively.
Ball and colleagues reported on quality-of-life (QOL) outcomes on a subset of 719 patients with localized prostate cancer treated with a variety of techniques including cryosurgical ablation. (23) They reported that, in an older population, the tissue destruction resulting from cryoablation appeared to relieve obstructive and irritative urinary symptoms but at the sacrifice of sexual function compared with palladium-103 brachytherapy.
Williams et al. compared data from the United States Surveillance, Epidemiology, and End Results (SEER) Medicare-linked data on 10,928 patients with localized prostate cancer treated with primary cryoablation or brachytherapy. (24) Urinary and erectile dysfunction occurred significantly more frequently with cryoablation than brachytherapy (41.4% and 34.7% vs. 22.2% and 21%, respectively). The use of androgen deprivation therapy also occurred significantly more often after cryoablation than brachytherapy, suggesting a higher rate of recurrence after cryoablation (1.4 vs. 0.5 per 100 person years). Bowel complications, however, occurred significantly more frequently with brachytherapy (19%) than cryoablation (12.1%).
Salvage Prostate Cryoablation
Studies have described results from using cryoablation for patients with recurrent, localized prostate cancer following a course of radiation therapy. In 2012, Mouraviev et al reviewed literature published between 1991 and 2012 to compare salvage cryoablation for radio-recurrent prostate cancer with other salvage treatments.(25) The authors reported comparisons were difficult to make because no prospective, randomized studies were identified and PSA failure is defined in various ways. However, the authors noted studies have reported salvage cryoablation outcomes that are comparable with salvage radical prostatectomy on an intermediate term. PSA level less than 10 ng/mL, Gleason score 8 or less, and clinical stage T1c or T2 before salvage cryoablation therapy were identified as favorable prognostic factors. In a 2013 systematic review, Punnen et al evaluated management approaches, including cryoablation, for salvage treatment (biochemical recurrence) after primary treatment for localized prostate cancer.(26) The reviewer noted while there is limited evidence available, cryotherapy is a possible treatment option for salvage therapy although randomized trials are needed.
Wenske et al reported on salvage cryoablation in a series of 396 consecutively treated patients who had failed cryoablation or radiotherapy.(27) Data was analyzed from 328 patients with a median follow-up of 47.8 months (range, 1.6-203.5). Fifty-five (16.7%) of these patients received subtotal (focal) salvage cryoablation. At 5- and 10-year follow-ups, DFS was 63% and 35%, DSS was 91% and 79%, and OS was 74% and 45%, respectively. After salvage cryoablation, median PSA nadir was 0.2 ng/mL (range, 0.01-70.70 ng/mL) at a median follow-up of 2.6 months (range, 2.0-67.3 months). PSA nadir was the only predictor of recurrence and DSS in multivariate analyses (p<0.001 and p=0.012, respectively). Complications occurred in 0.6% to 4.6% of patients. In the 55 patients that received subtotal (focal) salvage cryoablation, median PSA nadir was 0.44 ng/mL (range, 0.04-20.1 ng/mL) and recurrence was seen in 27 patients (49%). At 5- and 10-years’ follow-up, DFS was 47% and 42%, DSS was 100% and 83%, and OS was 87% and 81%, respectively.
Ng et al reported on a series of 187 patients with locally recurrent prostate cancer after radiotherapy who underwent salvage cryoablation of the prostate and were studied after a mean follow-up of 39 months.(28) Serum PSA at cryoablation was a predictive factor for biochemical recurrence on univariate and multivariate analysis (p<0.001). Patients with a precryoablation PSA value less than 4 ng/mL had a 5-and 8-year biochemical recurrence-free survival (bRFS) of 56% and 37%, respectively. In contrast, patients with a precryoablation PSA of 10 ng/mL or greater had a 5- and 8-year bRFS of only 1% and 7%, respectively. Patients with a precryoablation PSA in the range of 4 to 9.99 ng/mL had intermediate survival outcomes. Overall 5- and 8-year survival was 97% and 92%, respectively. The authors concluded that salvage cryoablation is a viable treatment option for patients with prostate cancer in whom radiotherapy has failed and that salvage cryoablation should be performed when the serum PSA level is still relatively low because, in these patients, the procedure may potentially be curative. Similarly, Ismail et al reported on 100 patients treated between May 2000 and November 2005 with cryoablation for recurrent prostate cancer after radiotherapy; mean follow-up was 33.5 months.(29) All patients had biopsy-confirmed recurrent prostate cancer. bRFS was defined using a PSA level of less than 0.5 ng/mL and by applying the American Society for Therapeutic Radiology and Oncology (ASTRO) definition for biochemical failure. Patients were stratified into 3 risk groups, ie, high risk (68 men), intermediate risk (20 men), and low risk (12 men). There were no operative or cancer-related deaths; the 5-year actuarial bRFS was 73%, 45%, and 11% for the low-, intermediate- and high-risk groups, respectively. Complications included incontinence (13%), erectile dysfunction (86%), lower urinary tract symptoms (16%), prolonged perineal pain (4%), urinary retention (2%), and recto-urethral fistula (1%). The authors concluded that salvage cryoablation is a safe and effective treatment for localized prostate cancer recurrence after radiotherapy. Williams et al reported on a retrospective review of 176 patients receiving salvage cryoablation for locally recurrent prostate cancer during the period of 1995 to 2004.(30) Patients were followed a mean of 7.46 years, with 52 patients having been followed for more than 10 years. The 10-year DFS rate was 39%. The authors found risk factors for prostate cancer recurrence following salvage cryoablation were presalvage PSA levels, preradiation, and presalvage Gleason scores. Early recurrence was highly predicted by PSA nadir greater than 1.0 ng/dL after salvage cryoablation.
Subtotal (Focal) Prostate Cryoablation
There is minimal evidence for use of the technique of subtotal prostate cryoablation for treatment of localized disease. In one representative publication on focal therapy, Truesdale and colleagues reported on a retrospective chart review of 77 patients with unilateral prostate cancer treated with primary focal cryosurgery between 2002 and 2009. (30) Using D'Amico risk classifications, 44 patients were considered low-risk, 31 were intermediate-risk, and 2 were high-risk disease. Patients were followed for a median time of 24 months, and the biochemical (PSA) progression-free survival rate was 72.7% overall. Prostate cancer was confirmed by biopsy in 10 of 22 patients suspected of having recurrent disease (2 ipsilateral, 7 contralateral, and 1 bilateral disease). The overall pathologic progression-free survival rate was 87%. Disease progression was correlated with pretreatment PSA levels, pretreatment Gleason scores, number of positive cores, and total tumor lengths. Comparative data from studies with longer follow-up are needed to evaluate this technology.
Bahn and coworkers reported on use of focal prostate cryoablation with “less-than-complete” ablation of the gland with ice, which spares contralateral prostate tissue and surrounding structures. (31) Results on 31 men with a mean follow-up of 70 months showed biochemical disease-free status of 92.8%. Potency (either with or without oral medications) was 88.9%. The authors indicated that further investigation is needed. Bahn and colleagues subsequently reported on a retrospective review of 73 patients with low-intermediate risk, unilateral prostate cancer followed for a median of 3.7 months (range 1-8.5 years) after focal cryotherapy. (32) Mean PSA level decreased 70% from 5.9 ng/mL to 1.6 ng/mL after cryoablation of one lobe (p<0.001). Prostate biopsy was performed in 48 patients after focal cryotherapy and was negative in 36 (75%) patients. Incontinence was not documented in any patient, and impotence was noted in 14% of patients.
Ward and Jones reported on a retrospective review of 1,160 patients with localized prostate cancer treated with focal cryoablation between 1997 and 2007 from the national Cryo On-Line Database (COLD) Registry. (33) At 36 months, the biochemical recurrence-free rate (bDFS) was 75.7%. Prostate biopsy was positive in 43 (26.3%) of 164 patients biopsied for suspected cancer recurrence or 3.7% of all cryoablation patients. Incontinence and impotence were each documented in 1.6% of patients. Six patients (1.1%) experienced urinary retention for more than 30 days There is minimal evidence for use of the technique of subtotal prostate cryoablation for treatment of localized disease. In one representative publication on focal therapy, Truesdale et al reported on a retrospective chart review of 77 patients with unilateral prostate cancer treated with primary focal cryosurgery between 2002 and 2009.(31) Using D'Amico risk classifications, 44 patients were considered low risk, 31 were intermediate risk, and 2 were high risk disease. Patients were followed for a median time of 24 months, and the biochemical (PSA) PFS rate was 72.7% overall. Prostate cancer was confirmed by biopsy in 10 of 22 patients suspected of having recurrent disease (2 ipsilateral, 7 contralateral, and 1 bilateral disease). The overall pathologic PFS rate was 87%. Disease progression was correlated with pretreatment PSA levels, pretreatment Gleason scores, number of positive cores, and total tumor lengths. Comparative data from studies with longer follow-up are needed to evaluate this technology.
Bahn et al reported on use of focal prostate cryoablation with “less-than-complete” ablation of the gland with ice, which spares contralateral prostate tissue and surrounding structures.(32) Results on 31 men with a mean follow-up of 70 months showed biochemical disease-free status of 92.8%. Potency (either with or without oral medications) was 88.9%. The authors indicated that further investigation is needed.
Bahn et al subsequently reported on a retrospective review of 73 patients with low-intermediate risk, unilateral prostate cancer followed for a median of 3.7 months (range 1-8.5 years) after focal cryotherapy.(33) Mean PSA level decreased 70% from 5.9 ng/mL to 1.6 ng/mL after cryoablation of 1 lobe (p<0.001).Prostate biopsy was performed in 48 patients after focal cryotherapy and was negative in 36 (75%) patients. Incontinence was not documented in any patient, and impotence was noted in 14% of patients.
Ward and Jones reported on a retrospective review of 1160 patients with localized prostate cancer treated with focal cryoablation between 1997 and 2007 from the national Cryo On-Line Database (COLD) Registry.(34) At 36 months, the bDFS was 75.7%. Prostate biopsy was positive in 43 (26.3%) of 164 patients biopsied for suspected cancer recurrence or 3.7% of all cryoablation patients. Incontinence and impotence were each documented in 1.6% of patients. Six patients (1.1%) experienced urinary retention for more than 30 days.
A search of Clinical Trials.gov identified 7 active studies on cryotherapy for prostate cancer. The only phase 3 study began in July 2011 and will randomize high-risk localized prostate cancer patients to receive cryoablation either with or without androgen deprivation therapy (NCT01398657). This study is expected to enroll 182 patients and be completed in June 2016. In another study, biochemical failure and quality-of-life outcomes will be evaluated in an estimated 800 patients in the prospective, multicenter registry of salvage cryotherapy in recurrent prostate cancer (SCORE) trial (NCT00824928). This study began in January 2007 and is expected to be completed in December 2014.
Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
In response to requests, input was received from 1 physician specialty society and 4 academic medical centers while this policy was under review for March 2009. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. There was strong agreement that cryoablation should be considered medically necessary as one option in the initial treatment of organ-confined prostate cancer, as well as for use as salvage therapy for disease that recurs after radiation therapy.
Cryoablation, also known as cryotherapy or cryosurgery, of prostate cancer is a technique in which cryoprobes are inserted percutaneously into the prostate gland to rapidly freeze and thaw tissue causing necrosis.
The available evidence for use of cryotherapy in the treatment of clinically localized (organ-confined) prostate cancer when performed as initial treatment or as salvage treatment of disease that recurs following radiation therapy is sufficient to demonstrate improvement in net health outcome. This conclusion is based on the extensive data from cohort studies and clinical input including an indirect chain of evidence and the recognition that the data for this long-used technique are similar to data for a number of accepted techniques. While the data for treatment of recurrence after radiation therapy are limited, these patients have few options; one option with recurrence is prostatectomy, which can be difficult in tissue that has been irradiated. However, for patients with recurrence after radiation therapy who elect further treatment, based on the limited data available, cryosurgical treatment does appear to produce anti-tumor activity.
Given the lack of long-term follow-up data, including a lack of comparative studies, subtotal prostate cryoablation is considered investigational.
Practice Guidelines and Position Statements
The National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer indicate cryosurgery is appropriate for postradiation recurrence in patients who have a positive prostate biopsy and negative studies for metastasis. (35) However, the NCCN guidelines indicate cryotherapy as primary therapy is not recommended. The discussion notes that there are insufficient data available from long-term studies comparing cryotherapy with radiation and radical prostatectomy.
The 2008 American Urological Association Best Practice Statement has recognized cryoablation of the prostate as an appropriate treatment option for newly diagnosed or radiorecurrent organ-confined prostate cancer. (36) However, this Best Practice Statement indicates cryoablation in patients with clinical T3 disease is undetermined. In addition, long-term results of subtotal prostate cryoablation are noted as being unavailable.
Medicare National Coverage
CMS indicates cryotherapy is medically necessary and appropriate as primary treatment for clinically localized prostate cancer in stages T1-T-3. (2) Salvage cryotherapy is only medically necessary and appropriate in localized disease when radiation therapy has failed as primary treatment and the patient meets 1 of 3 criteria: stage T2B or below, Gleason score less than 9 or PSA less than 8 ng/mL. Salvage cryotherapy after failure of other therapies is not covered.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Cryoablation for the primary treatment of clinically localized prostate cancer. TEC Assessments 2001; Volume16, Tab 6.
- Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Cryosurgery of Prostate (230.9). 2001. Available online at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=123&bc=AgAAQAAAAAAA&ncdver=1. Last accessed April 2013.
- Shelley M, Wilt TJ, Coles B et al. Cryotherapy for localised prostate cancer. Cochrane Database Syst Rev 2007; (3):CD005010.
- Wilt TJ, Shamliyan T, Taylor B et al. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer . Rockville (MD)2008.
- Chou R, Dana T, Bougatsos C et al. Treatments for Localized Prostate Cancer: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation . Rockville (MD)2011.
- Grimm P, Billiet I, Bostwick D et al. Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group. BJU Int 2012; 109 Suppl 1:22-9.
- Chin JL, Ng CK, Touma NJ et al. Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer. Prostate Cancer Prostatic Dis 2008; 11(1):40-5.
- Chin JL, Al-Zahrani AA, Autran-Gomez AM et al. Extended followup oncologic outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2c-T3b). J Urol 2012; 188(4):1170-5.
- Donnelly BJ, Saliken JC, Brasher PM et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010; 116(2):323-30.
- Robinson JW, Donnelly BJ, Siever JE et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer: quality of life outcomes. Cancer 2009; 115(20):4695-704.
- Bahn DK, Lee F, Badalament R et al. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology 2002; 60(2 Suppl 1):3-11.
- Donnelly BJ, Saliken JC, Ernst DS et al. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology 2002; 60(4):645-9.
- Ellis DS. Cryosurgery as primary treatment for localized prostate cancer: a community hospital experience. Urology 2002; 60(2 Suppl 1):34-9.
- Long JP, Bahn D, Lee F et al. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology 2001; 57(3):518-23.
- Onik G. Image-guided prostate cryosurgery: state of the art. Cancer Control 2001; 8(6):522-31.
- Robinson JW, Donnelly BJ, Saliken JC et al. Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery. Urology 2002; 60(2 Suppl 1):12-8.
- Aus G, Pileblad E, Hugosson J. Cryosurgical ablation of the prostate: 5-year follow-up of a prospective study. Eur Urol 2002; 42(2):133-8.
- De La Taille A, Benson MC, Bagiella E et al. Cryoablation for clinically localized prostate cancer using an argon-based system: complication rates and biochemical recurrence. BJU Int 2000; 85(3):281-6.
- Han KR, Cohen JK, Miller RJ et al. Treatment of organ confined prostate cancer with third generation cryosurgery: preliminary multicenter experience. J Urol 2003; 170(4 Pt 1):1126-30.
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- Ball AJ, Gambill B, Fabrizio MD et al. Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution. J Endourol 2006; 20(10):723-31.
- Williams SB, Lei Y, Nguyen PL et al. Comparative effectiveness of cryotherapy vs brachytherapy for localised prostate cancer. BJU Int 2011.
- Mouraviev V, Spiess PE, Jones JS. Salvage Cryoablation for Locally Recurrent Prostate Cancer Following Primary Radiotherapy. Eur Urol 2012.
- Punnen S, Cooperberg MR, D'Amico AV et al. Management of biochemical recurrence after primary treatment of prostate cancer: a systematic review of the literature. Eur Urol 2013; 64(6):905-15.
- Wenske S, Quarrier S, Katz AE. Salvage Cryosurgery of the Prostate for Failure After Primary Radiotherapy or Cryosurgery: Long-term Clinical, Functional, and Oncologic Outcomes in a Large Cohort at a Tertiary Referral Centre. Eur Urol 2012 [Epub ahead of print].
- Ng CK, Moussa M, Downey DB et al. Salvage cryoablation of the prostate: followup and analysis of predictive factors for outcome. J Urol 2007; 178(4 Pt 1):1253-7; discussion 57.
- Ismail M, Ahmed S, Kastner C et al. Salvage cryotherapy for recurrent prostate cancer after radiation failure: a prospective case series of the first 100 patients. BJU Int 2007; 100(4):760-4.
- Williams AK, Martinez CH, Lu C et al. Disease-free survival following salvage cryotherapy for biopsy-proven radio-recurrent prostate cancer. Eur Urol 2011; 60(3):405-10.
- Truesdale MD, Cheetham PJ, Hruby GW et al. An evaluation of patient selection criteria on predicting progression-free survival after primary focal unilateral nerve-sparing cryoablation for prostate cancer: recommendations for follow up. Cancer J 2010; 16(5):544-9.
- Bahn DK, Silverman P, Lee F, Sr. et al. Focal prostate cryoablation: initial results show cancer control and potency preservation. J Endourol 2006; 20(9):688-92.
- Bahn D, de Castro Abreu AL, Gill IS et al. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol 2012; 62(1):55-63..
- Ward JF, Jones JS. Focal cryotherapy for localized prostate cancer: a report from the national Cryo On-Line Database (COLD) Registry. BJU Int 2011.
- National Cooperative Cancer Network. Prostate cancer. Clinical Practice Guidelines in Oncology, v.2.2013. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Last accessed April 2013.
- Best practice policy statement on cryosurgery for the treatment of localized prostate cancer. American Urological Association Education and Research, Inc. Linthicum (MD): American Urological Association Education and Research, Inc.; 2008. 50 p. Available online at: http://www.auanet.org/content/media/cryosurgery08.pdf. Last accessed April 2013.
|CPT||55873||Cryosurgical ablation of the prostate (includes ultrasonic guidance for interstitial cryosurgical probe placement)|
|ICD-9 Procedure||60.62||Perineal prostatectomy (includes cryoablation of prostate)|
|ICD-9 Diagnosis||185||Malignant neoplasm of prostate|
|198.82||Secondary malignant neoplasm of prostate|
|233.4||Carcinoma in situ of the prostate|
|V10.46||Personal history of malignant neoplasm, prostate|
|ICD-10-PCS (effective 10/1/15)||C61||Malignant neoplasm of prostate|
|C79.82||Secondary malignant neoplasm of genital organs|
|D07.5||Carcinoma in situ prostate|
|Z85.46||Personal history malignant neoplasm of prostate|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.|
|0V500ZZ, 0V503ZZ, 0V504ZZ||Surgical, destruction, prostate, code by approach (open, percutaneous, percutaneous endoscopic)|
|Type of Service||Surgery|
|Place of Service||Inpatient|
Cryosurgical Ablation, Prostate
Prostate, Cryosurgical Ablation
Add to Surgery section
Policy updated; policy statement unchanged
Policy updated; policy statement unchanged
Policy updated with literature search; reference 12 and ICD-9 procedure code added; no change in policy statement
|Policy updated with literature search; no change in policy statement. Reference numbers 13 and 14 added.|
|04/24/09||Replace policy||Policy updated with literature search; reference numbers 15 to 20 added. Policy statement for primary cancer changed to medically necessary; new policy statement added that treatment of recurrent localized prostate cancer may be considered medically necessary; new policy statement added that subtotal cryoablation is investigational. “Clinically localized” removed from policy title|
|05/12/11||Replace policy||Policy updated with literature search through February 2011; no change in policy statement. Reference numbers 21-26 added|
|5/10/12||Replace policy||Policy updated with literature search; no change in policy statement. Rationale section rewritten. Reference numbers 5-6, 21, 23-24 and 30-31 added|
|5/09/13||Replace policy||Policy updated with literature search through March 2013; no change in policy statement. Reference numbers 8 and 26 added; reference numbers 2, 34, and 35 updated|
Policy updated with literature review through April 25, 2014; no change in policy statements. Reference number 26 added. Regulatory Status information added to Background section.