Asset Publisher


print Print Back Back

Whole Gland Cryoablation of Prostate Cancer

Policy Number: MP-384

Latest Review Date: August 2023

Category: Surgery                                                     


Whole gland cryoablation of the prostate may be considered medically necessary as a treatment of clinically localized (organ-confined) prostate cancer when performed:

  • As initial treatment; OR
  • As salvage treatment of disease that recurs following radiation therapy.

For focal or subtotal prostate cryoablation, refer to medical policy 596: Focal Treatments for Prostate Cancer


Prostate Cancer

Prostate cancer is the most commonly diagnosed cancer in men and the second leading cause of cancer death among men in the U. S., with an estimated 288,300 new cases and 34,700 deaths in 2023. The diagnosis and grading of prostate cancer are performed by taking a biopsy of the prostate gland.

Cryoablation, also known as cryotherapy or cryosurgery, is a procedure that attacks cancer cells using extremely cold gas. This technique can be used to combat prostate cancer by percutaneously inserting thin, needle-like cryoprobes into the prostate gland; then, sending very cold gas down the cryoprobes to rapidly freeze and thaw the tissue, causing necrosis. This review evaluates evidence on the use of total (whole gland, definitive therapy) cryoablation. Subtotal or focal cryoablation and alternatives to this procedure are addressed in medical policy #596- Focal Treatments for Prostate Cancer.


Whole gland (also known as total) cryoablation is one of several methods used to treat clinically localized prostate cancer and may be considered an alternative to radical prostatectomy or external-beam radiotherapy (EBRT). Additionally, whole gland cryoablation may be used for salvage of nonmetastatic relapse following initial therapy for clinically localized disease. Using percutaneously inserted cryoprobes, the glandular tissue is rapidly frozen and thawed to cause tissue necrosis. Cryosurgical ablation is less invasive than radical prostatectomy and recovery time may be shorter. External-beam radiotherapy requires multiple treatments, whereas cryoablation usually requires a single treatment.


The most recent literature review was performed through June 23, 2023.

Summary of Evidence

For individuals who are considering initial treatment for localized prostate cancer who receive whole gland cryoablation, the evidence includes systematic reviews, 2 randomized controlled trials, and many comparative and noncomparative observational studies. Relevant outcomes are overall survival (OS), disease-specific survival, symptoms, functional outcomes, quality of life (QOL), and treatment-related morbidity. High-quality data comparing cryoablation with external-beam radiotherapy (EBRT), radical prostatectomy, or active surveillance are lacking, but available data have suggested similar OS and disease-specific survival rates compared with radical prostatectomy and EBRT. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have salvage treatment for a recurrence of localized prostate cancer following radiotherapy who receive whole gland cryoablation, the evidence primarily includes case series and a few retrospective studies comparing salvage cryoablation with salvage prostatectomy or brachytherapy. Relevant outcomes are OS, disease-specific survival, symptoms, functional outcomes, QOL, and treatment-related morbidity. High-quality data comparing salvage cryoablation with salvage prostatectomy or brachytherapy are lacking, though limited evidence suggests that salvage cryotherapy may be associated with better survival outcomes than prostatectomy. Men with recurrent localized prostate cancer have limited treatment options and prostatectomy can be difficult in tissue that has been irradiated. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) guidelines (v.1.2023) for prostate cancer indicate cryosurgery and high-intensity focused ultrasound are options for radiotherapy recurrence in patients who have no evidence of metastatic disease (Grade 2B). NCCN does not recommend cryotherapy as routine primary therapy for localized prostate cancer due to limited long-term data comparing cryotherapy with radiation or radical prostatectomy.

American Urological Association

In 2022, the American Urological Association and the American Society for Radiology Oncology issued a joint, updated guideline on the  treatment of clinical localized prostate cancer; the guideline was additionally endorsed by the Society of Urologic Oncology. In the guideline, treatment recommendations are stratified according to risk group, and ablative techniques are discussed in general with no recommendations specific to whole-gland cryoablation (Table 1).

Table 1. Treatment Recommendations Related to Cryoablation by Prostate Cancer Risk Group

Severity/Risk Group

Risk Definition

Treatment Recommendation



Clinical Considerations

Low-risk disease

PSA <10 ng/mL AND Grade Group 1 AND clinical stage T1-T2a

For patients with low-risk prostate cancer, clinicians should recommend active surveillance as the preferred management option



The Panel believes that the benefits of aggressive treatment do not outweigh the risk of treatment-related harms for most patients with low-risk disease.


The Panel acknowledges that select patients with low-risk disease may elect definitive local therapy after an informed discussion between clinician and patient.

Intermediate-risk disease


PSA 10-<20 ng/mL OR Grade Group 2-3 OR clinical stage T2b-c

Clinicians should inform patients with

intermediate-risk prostate cancer considering whole gland or focal ablation that there are a lack of high-quality data comparing ablation outcomes to radiation therapy, surgery, and active surveillance

Expert opinion


The Panel believes that ablation maybe considered in select, appropriately informed patients (with clinical trial enrollment prioritized).


Patients considering ablation should be counseled regarding side effects and recurrence risk and should be followed post-ablation with PSA, DRE, MRI, and biopsy tailored to their specific health and cancer characteristics.

High-risk disease

PSA>20 ng/mL OR Grade Group 4-5 OR clinical stageT3

Clinicians should not recommend whole gland or focal ablation for patients with high-risk prostate cancer outside of a clinical trial

Expert opinion


There is a lack of data supporting treatment of high-risk disease with ablation.

DRE: digital rectal exam; GOE: grade of evidence; HIFU: high-intensity focused ultrasound; LOE: level of evidence; MRI: magnetic resonance imaging; PSA: prostate-specfic antigen.

U.S. Preventive Services Task Force Recommendations

A systematic review of localized prostate cancer treatments was prepared by Fenton et al (2018) for the Agency for Healthcare Research and Quality, to update the 2002 U.S. Preventive Services Task Force Recommendation. 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, found to be very limited and not sufficiently reliable to estimate the benefits or harms of cryoablation.


Cryosurgery, Prostate, Cryosurgical Ablation, whole gland cryoablation


Cryoablation of prostate cancer is a surgical procedure that uses previously approved and available cryoablation systems; as a surgical procedure, it is not subject to regulation by the U.S. Food and Drug Administration (FDA).


Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 


CPT Codes:


Cryosurgical ablation of the prostate (includes ultrasonic guidance for interstitial cryosurgical probe placement)


  1. American Urological Association (AUA). Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. 2022;
  2. 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 Oct 2012; 188(4):1170-1175.
  3. Chin JL, Lavi A, Metcalfe MJ, et al. Long-Term Outcomes of Whole Gland Salvage Cryotherapy for Locally Recurrent Prostate Cancer following Radiation Therapy: A Combined Analysis of Two Centers. J Urol. Sept 2021; 206(3): 646-654.
  4. Elkjaer Mc, Borre M. Oncological outcome after primary prostate cryoablation compared with radical prostatectomy: A single-centre experience. Scand J Urol. Feb 2014;48(1):27-33.
  5. European Association of Urology (EAU). EAU-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. 2017; 
  6. Fenton JJ, Weyrich, MS, Durbin S, et al. U.S. Preventive Services Tast Force. Evidence Summary for prostate cancer screening. 
  7. Friedlander DF, Gu X, Prasad SM, et al. Population-based comparative effectiveness of salvage radical prostatectomy vs cryotherapy. Urology. Mar 2014; 83(3):653-657.
  8. Gao L, Yang L, Qian S, et al. Cryosurgery would be an effective option for clinically localized prostate cancer: A meta-analysis and systematic review. Sci Rep. Jun 07 2016; 6:27490.
  9. 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):22-29.
  10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  11. Kulik M, Nedelcu C, Martin F, et al. Post-treatment MRI aspects of photodynamic therapy for prostate cancer. Insights Imaging. Dec 2014; 5(6):697-713.
  12. Lian H, Guo H, Gan W et al. Cryosurgery as primary treatment for localized prostate cancer. Int Urol Nephrol Dec 2011; 43(4):1089-1094.
  13. Mottet N, Bellmunt J, Bolla M, et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. Apr 2017;71(4):618-629.
  14. Mouraviev V, Spiess PE, Jones JS. Salvage cryoablation for locally recurrent prostate cancer following primary radiotherapy. Eur Urol. Jun 2012;61(6):1204-1211.
  15. National Cancer Institute Surveillance, Epidemiology and End Results Program. Cancer Stat Facts: Common Cancer Sites.
  16. National Comprehensive Cancer Network. Prostate Cancer. Version 1.2023.
  17. Peters M, Moman Mr, Van Der Poel Hg, et al. Patterns of outcome and toxicity after salvage prostatectomy, salvage cryosurgery and salvage brachytherapy for prostate cancer recurrences after radiation therapy: A multi-center experience and literature review. World J Urol. Apr 2013; 31(2):403- 409.
  18. 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):905-915.
  19. Ramsay Cr, Adewuyi Te, Gray J, et al. Ablative therapy for people with localized prostate cancer: A systematic review and economic evaluation. Health Technol Assess. Jul 2015; 19(49):1-490.
  20. Siddiqui K, Billia M, Al-Zahrani A, et al. Long-term oncologic outcomes of salvage cryoablation for radio-recurrent prostate cancer. J Urol. Oct 2016; 196(4):1105-1111.
  21. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. 67. Jan 5 2017;1(7-30).
  22. Spiess P, Levy D, Pisters L, et Al. Outcomes of salvage prostate cryotherapy stratified by pretreatment PSA: Update from the cold registry. World J Urol. Dec 2013; 31(6):1321-1325.
  23. Tan WP, Kotamarti S, Ayala A, et al. Oncological and Functional Outcomes for Men Undergoing Salvage Whole-glandCryoablation for Radiation-resistant Prostate Cancer. Eur Urol Oncol. Jun 2023; 6(3): 289-294.
  24. Tay K, Polascik T, Elshafei A, et al. Primary cryotherapy for high-grade clinically localized prostate cancer: Oncologic and functional outcomes from the cold registry. J Endourol. Jan 2016; 30(1):43-48.
  25. 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 center. Eur Urol. 2013 Jul; 64(1):1-7.
  26. Williams AK, Martínez CH, Lu C et al. Disease-free survival following salvage cryotherapy for biopsy-proven radio-recurrent prostate cancer. Eur Urol Sept 2011; 60(3):405-410.
  27. Williams SB, Lei Y, Nguyen PL, et al. Comparative effectiveness of cryotherapy vs brachytherapy for localised prostate cancer. BJU Int. Jul 2012;110(2 Pt 2):E92-98.
  28. Xiong T, Turner RM, Wei Y, et al. Comparative efficacy and safety of treatments for localised prostate cancer: an application of network meta-analysis. BMJ Open. May 15 2014; 4(5):e004285.


Medical Policy Group, August 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, June 2011 (3): Update to Key Points & References; no change to policy statement

Medical Policy Group, June 2012 (3): Update to Key Points & References; no change to policy statement

Medical Policy Panel, May 2013

Medical Policy Group, September 2013 (1): Update to Descriptions, Key Points and References; no change to policy statement

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (1) Update to Key Points, Governing Bodies and References; no change to policy statement

Medical Policy Group, April 2015 (4): Added statement under policy section: “Refer also to medical policy # 596- Focal Treatments for Prostate Cancer.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (4):  Updates to Description, Key Points, Key Words and References.  Policy statement clarification to “Whole gland”; intent of policy statement unchanged. Strike through of focal cryoablation of prostate policy statement and information on focal therapy was removed from this policy, as this information is addressed in MP# 596.

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (4): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (4): Updates to Description, Practice Guidelines and Key points.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (4): Updates to Description, Key points, and References. No change in Policy Statement.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (5): Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (5): Minor updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, U.S. Preventive Services Task Force Recommendations, and References. No change to Policy Statement. 

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (11): Updates to Description, Key Points, Benefit Application, and References. No change to Policy Statement. 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.