Latest Review Date: September 2023

Category: Surgery                                                     

POLICY:

The use of any focal or subtotal therapy modality to treat individuals with localized prostate cancer is considered investigational.

***Refer also to medical policy 178: MRI-Guided Focused Ultrasound (MRgFUS)

***Refer also to medical policy 384: Whole gland Cryoablation of Prostate Cancer

***Refer also to medical policy 119: Radiofrequency Ablation of Solid Tumors Excluding Liver Tumors

***Refer also to medical policy 337: Oncologic Applications of Photodynamic Therapy, Including Barrett’s Esophagitis

DESCRIPTION OF PROCEDURE OR SERVICE:

Prostate cancer is the second most common cancer diagnosis men receive in the United States, and the behavior of localized prostate cancer can prove difficult to predict on a case-by-case basis. Most men with the cancer undergo whole-gland treatments, which can often lead to substantial adverse effects. In an effort to reduce tumor burden and minimize morbidity associated with radical treatment, investigators have developed a therapy known as focal treatment. Focal treatment seeks to ablate either an “index” lesion (defined as the largest cancerous lesion with the highest-grade tumor), or, alternatively, to ablate nonindex lesions and other areas where cancer has been known to occur. Addressed in this review are several ablative methods used to remove cancerous lesions in localized prostate cancer (e.g., focal laser ablation, high-intensity focused ultrasound [HIFU], cryoablation, radiofrequency ablation [RFA], photodynamic therapy). All methods, except focal laser ablation, use ultrasound guidance to focus on the tumor (focal laser ablation uses magnetic resonance imaging to guide the probe).

Prostate Cancer

Prostate cancer is the second most common cancer diagnosed among men in the U.S. According to the National Cancer Institute, nearly 268,490 new cases are estimated to be diagnosed in the U.S. in 2022, associated with around 34,500 deaths. Prostate cancer is more likely to develop in older men and in non-Hispanic Black men. About 6 in 10 cases are diagnosed in men who are ≥65 years of age, and it is rare in men <40 years of age. Autopsy studies in the pre-prostate-specific antigen (PSA) screening era identified incidental cancerous foci in 30% of men 50 years of age, with incidence reaching 75% at age 80 years. However, the National Cancer Institute Surveillance Epidemiology and End Results Program data have shown that age-adjusted cancer-specific mortality rates for men with prostate cancer declined from 40 per 100,000 in 1992 to 19 per 100,000 in 2018. This decline has been attributed to a combination of earlier detection via PSA screening and improved therapies.

Diagnosis

From a clinical standpoint, different types of localized prostate cancers may appear similar during initial diagnosis. However, prostate cancer often exhibits varying degrees of risk progression that may not be captured by accepted clinical risk categories (eg, D’Amico criteria) or prognostic tools based on clinical findings (eg, PSA titers, Gleason grade, or tumor stage). In studies of conservative management, the risk of localized disease progression based on prostate cancer-specific survival rates at 10 years may range from 15% to 20% to perhaps 27% at 20-year follow-up. Among elderly men (≥70 years) with this type of low-risk disease, comorbidities typically supervene as a cause of death; these men will die from the comorbidities of prostate cancer rather than from cancer itself. Other very similar-appearing low-risk tumors may progress unexpectedly and rapidly, quickly disseminating and becoming incurable.

Treatments

The divergent behavior of localized prostate cancers creates uncertainty about whether to treat immediately. A patient may choose definitive treatment upfront. Surgery (radical prostatectomy) or external-beam radiotherapy (EBRT) are most commonly used to treat patients with localized prostate cancer. Complications most commonly reported with radical prostatectomy or EBRT and with the greatest variability are incontinence (0%-73%) and other genitourinary toxicities (irritative and obstructive symptoms); hematuria (typically ≤5%); gastrointestinal and bowel toxicity, including nausea and loose stools (25%-50%); proctopathy, including rectal pain and bleeding (10%-39%); and erectile dysfunction, including impotence (50%-90%).

American Urological Association guidelines suggest state that for patients with low-risk prostate cancer, clinicians should recommend active surveillance. With this approach, patients forego immediate therapy but continue regular monitoring until signs or symptoms of disease progression are evident, at which point curative treatment is instituted.

Focal Treatment of Localized Prostate Cancer

Given significant uncertainty in predicting behavior of individual localized prostate cancers, and the substantial adverse effects associated with definitive treatments, investigators have sought a therapeutic “middle ground.” The latter seeks to minimize morbidity associated with radical treatment in those who may not actually require it while reducing tumor burden to an extent that reduces the chances for rapid progression to incurability. This approach is termed focal treatment, in that it seeks to remove - using any of several ablative methods described next - cancerous lesions at high risk of progression, leaving behind uninvolved glandular parenchyma. The overall goal of focal treatment is to minimize the risk of early tumor progression and preserve erectile, urinary and rectal functions by reducing damage to the neurovascular bundles, external sphincter, bladder neck, and rectum. Although focal treatment is offered as an alternative middle approach to management of localized prostate cancer, several key issues must be considered in choosing it. They include patient selection, lesion selection, therapy monitoring, and the modality used to ablate lesions.

Patient Selection

A proportion of men with localized prostate cancer have been reported to have, or develop, serious misgivings and psychosocial problems in accepting active surveillance, sometimes leading to inappropriately discontinuing it. Thus, appropriate patient selection is imperative for physicians who must decide whether to recommend active surveillance or focal treatment for patients who refuse radical therapy or for whom it is not recommended due to the a risk-benefit balance.

Lesion Selection

Proper lesion selection is a second key consideration in choosing focal treatment of localized prostate cancer. Although prostate cancer has always been regarded as a multifocal disease, clinical evidence shows that between 10% and 40% of men who undergo radical prostatectomy for presumed multifocal disease actually have a unilaterally confined discrete lesion, which, when removed, would “cure” the patient. This view presumably has driven the use of region-targeted focal treatment variants, such as hemiablation of the half of the gland containing tumor, or subtotal prostate ablation via the “hockey stick” method. While these approaches can be curative, the more extensive the treatment, the more likely the functional adverse outcomes would approach those of radical treatments.

The concept that clinically indolent lesions comprise most of the tumor burden in a patient with organ-confined prostate cancer led to development of a lesion-targeted strategy, which is referred to as “focal therapy” in this evidence review. This involves treating only the largest and highest-grade cancerous focus (referred to as the “index lesion”), which has been shown in pathologic studies to determine clinical progression of disease. This concept is supported by molecular genetics evidence that suggests a single index tumor focus is usually responsible for disease progression and metastasis. The index lesion approach leaves in place small foci less than 0.5 cm in volume, with Gleason score less than 7 that are considered unlikely to progress over a 10- to 20-year period. This also leaves available subsequent definitive therapies as needed should disease progress.

Identification of prostate cancer lesions-disease localization-particularly the index lesion, is critical to oncologic success of focal therapy; equally imperative to success is the ability to guide focal ablation energy to the tumor and assess treatment effectiveness are additionally important to treatment success. At present, no single modality meets the requirements for all 3 activities (disease localization, focal ablation energy to the tumor, assessment of treatment effectiveness).  Systematic transrectal ultrasound (TRUS)‒guided biopsy alone has been investigated, but is considered insufficient for patient selection or disease localization for focal therapy.

Multiparametric magnetic resonance imaging (mp-MRI), typically including T1-, T2-, diffusion-weighted imaging, and dynamic contrast-enhanced imaging, has been recognized as a promising modality to risk-stratify prostate cancer and select patients and lesions for focal therapy. Evidence shows mp-MRI can detect high-grade, large prostate cancer foci with performance similar to transperineal prostate mapping (TPM) using a brachytherapy template. For example, for the primary end point definition (lesion, ≥4 mm; Gleason score, ≥3+4), with TPM as the reference standard, sensitivity, negative predictive value, and negative likelihood ratios with mp-MRI were 58% to 73%, 84% to 89%, and 0.3 to 0.5, respectively.  Specificity, positive predictive value, and positive likelihood ratios were 71% to 84%, 49% to 63%, and 2.0 to 3.44, respectively. The negative predictive value of mp-MRI appears sufficient to rule out clinically significant prostate cancer and may have clinical use in this setting. However, although mp-MRI technology has capability to detect and risk-stratify prostate cancer, several issues constrain its widespread use for these purposes (e.g., mpMRI requires highly specialized MRI-compatible equipment; biopsy within the magnetic resonance imaging (MRI) scanner is challenging; interpretation of prostate MRI images requires experienced uroradiologists) and it is still necessary to histologically confirm suspicious lesions using TPM.

Therapy Monitoring

Controversy exists as to the proper end points for focal therapy of prostate cancer. The primary end point of focal ablation of clinically significant disease with negative biopsies evaluated at 12 months posttreatment is generally accepted according to a European consensus report. The clinical validity of MRI to analyze the presence of residual or recurrent cancer compared with histologic findings is offered as a secondary end point. However, MRI findings alone are not considered sufficient in follow-up. Finally, although investigators indicate PSA levels should be monitored, they are not considered valid end points because the utility of PSA kinetics in tissue preservation treatments has not been established.

Modalities Used to Ablate Lesions

Five ablative methods for which clinical evidence is available are considered herein: focal laser ablation; high-intensity focused ultrasound (HIFU); cryoablation; radiofrequency ablation (RFA); and photodynamic therapy. Each method requires placement of a needle probe into a tumor volume followed by delivery of some type of energy that destroys the tissue in a controlled manner. All methods except focal laser ablation currently rely on ultrasound guidance to the tumor focus of interest; focal laser ablation uses MRI to guide the probe. This evidence review does not cover focal brachytherapy.

Focal Laser Ablation

FLA refers to the destruction of tissue using a focused beam of electromagnetic radiation emitted from a laser fiber introduced transperineal or transrectal into the cancer focus. Tissue is destroyed through thermal conversion of the focused electromagnetic energy into heat, causing coagulative necrosis. Other terms for FLA include photothermal therapy, laser interstitial therapy, and laser interstitial photocoagulation.

High-Intensity Focused Ultrasound

High-intensity focused ultrasound works by focusing high-energy ultrasound waves on a single location, which increases the local tissue temperature to over 80°C. This causes a discrete locus of coagulative necrosis of approximately 3x3x10 mm. The surgeon uses a transrectal probe to plan, carry out, and monitor treatment in a real-time sequence to ablate the entire gland or small discrete lesions.

Cryoablation

Cryoablation induces cell death through direct cellular toxicity from disruption of the cell membrane caused by ice-ball crystals and vascular compromise from thrombosis and ischemia secondary to freezing below -30°C. It is performed by transperineal insertion under TRUS guidance of a varying number of cryoprobe needles into the tumor.

Radiofrequency Ablation

RFA uses energy produced by a 50-watt generator with a frequency of 460 kHz. The energy is transmitted to the tumor focus through 15 needle electrodes inserted transperineally under ultrasound guidance into the tissue. It produces an increase in tissue temperature causing coagulative necrosis.

Photodynamic Therapy

PDT uses an intravenous photosensitizing agent that distributes to prostate tissue, followed by delivery of light via transperineally inserted needles. The light induces a photochemical reaction that causes production of reactive oxygen species that are highly toxic and reactive with tissue causing functional and structural damage (i.e., cell death). A major concern with PDT is that real-time monitoring of tissue effects is not possible, and the variable optical properties of prostate tissue complicate assessment of necrosis and treatment progress.

KEY POINTS:

The most recent literature review was updated through July 11, 2023.

Summary of Evidence

For individuals who have primary localized prostate cancer who receive focal therapy using laser ablation, HIFU, cryoablation, RFA, or photodynamic therapy, the evidence includes systematic reviews, studies from a registry cohort, and numerous observational studies. Relevant outcomes are overall survival (OS), disease-specific survival, symptoms, change in disease status, functional outcomes, quality of life (QoL), and treatment-related morbidity. The evidence is highly heterogeneous and inconsistently reports clinical outcomes. No prospective, comparative evidence was found for the majority of focal ablation techniques versus current standard treatment of localized prostate cancer, including radical prostatectomy, external-beam radiotherapy, or active surveillance. Methods have not been standardized to determine which and how many identified cancerous lesions should be treated for best outcomes. No evidence supports which, if any, of the focal techniques leads to better functional outcomes. Although high disease-specific survival rates have been reported, the short follow-up periods and small sample sizes preclude conclusions on the effect of any of these techniques on OS rates. The adverse event rates associated with focal therapies appear to be superior to those associated with radical treatments (eg, radical prostatectomy, external-beam radiotherapy); however, the evidence is limited in its quality, reporting, and scope. The evidence is insufficient 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 for prostate cancer (v.1.2023) recommend only cryosurgery and high-intensity focused ultrasound (HIFU) as local therapy options for radiotherapy recurrence in the absence of metastatic disease (category 2B). Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments to radiation or radical prostatectomy.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2019; updated in 2021) issued guidance on the use cryoablation for localized prostate cancerCryoablation and high-intensity ultrasound are not recommended for the treatment of localized prostate cancer because there is a lack of evidence on quality of life benefits and long-term survival.

American Urological Association et al

The American Urological Association, in collaboration with the American Society for Radiation Oncology (ASTRO) with additional representation from the American Society of Clinical Oncology (ASCO), and Society of Urologic Oncology (SUO) published updated guidelines on the management of clinically localized prostate cancer in 2022. The guidelines included the following recommendation on focal treatments:

• "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)"
• "Clinicians should not recommend whole gland or focal ablation for patients with high-risk prostate cancer outside of a clinical trial. (Expert Opinion)"

National Cancer Institute

The National Cancer Institute (NCI; 2021) updated its information on prostate cancer treatments. The NCI indicated that cryoablation, photodynamic therapy, and HIFU were new treatment options currently being studied in national trials. The NCI offered no recommendation for or against these treatments.

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force published recommendations for prostate cancer screening. However, there are no recommendations for focal treatment of prostate cancer.

KEY WORDS:

Focal Laser Ablation, FLA, High-Intensity Focused Ultrasound, HIFU, Cryoablation, Radiofrequency Thermal Ablation, Radiofrequency ablation, RFA, Photodynamic Therapy, PDT, prostate cancer, localized prostate cancer, Visualase® Thermal Therapy System, Ablatherm®, Visual-ICE®, Ice Rod CX, CryoCare®, IceSphere, Photofrin®, psoralen, porfimer sodium, ultraviolet lamps, Tranberg Thermal Therapy System, NanoTherm®, NanoActivator®, Magnetic Nanoparticles.

APPROVED BY GOVERNING BODIES:

Focal Laser Ablation

In 2010, the Visualase® Thermal Therapy System (Medtronic) and in 2015 the TRANBERG Laser fiber (Clinical Laserthermia Systems) were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging guidance in cardiothoracic surgery, dermatology, otolaryngology, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 to 1064 nm. In 2021, the FDA granted a breakthrough device designation to a novel artificial intelligence (AI)-enabled focal therapy system for the treatment of localized prostate cancer. The Avenda® Health Focal Therapy System combines an AI-based margin prediction software algorithm with focal laser ablation to deliver treatment directly to the prostate tumor. FDA product code: LLZ, GEX, FRN.

High-Intensity Focused US

In October 2015, the Sonablate® 450 (SonaCare Medical) was cleared for marketing through the 510(k) process after approval of a de novo request and classified the device as class II under the generic name “high intensity ultrasound system for prostate tissue ablation”. This device was the first of its kind to be approved in the United States. In November 2015, Ablatherm®-HIFU (EDAP TMS) was cleared for marketing by FDA through the 510(k) process. In June 2018, EDAP received 510(k) clearance for its Focal-One® HIFU device designed for prostate tissue ablation procedures. This device fuses magnetic resonance and 3D biopsy data with real-time ultrasound imaging, allowing urologists to view detailed images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area.

Cryotherapy

Some cryotherapy devices cleared for marketing by FDA through the 510(k) process for cryoablation of the prostate are: Visual-ICE® (Galil Medical), Ice Rod CX, CryoCare® (Galil Medical), and IceSphere (Galil Medical), and Cryocare® Systems (Endocare®). FDA product code: GEH.

Radiofrequency Ablation

Radiofrequency ablation devices have been cleared through the 510(k) process by FDA for the general use of soft tissue cutting and coagulation and ablation by thermal coagulation. Under this general indication, RFA may be used as a method to ablate tumors. FDA product code: GEI.

Photodynamic Therapy

FDA has granted approvals to several photosensitizing drugs and light applicators. Photofrin® (porfimer sodium) (Axcan Pharma) and psoralen are photosensitizers, ultraviolet lamps used in the treatment of cancer, were cleared from marketing by FDA through the 510(k) process. FDA product code: FTC.

In 2020, an FDA advisory committee voted against recommending approval of padeliporfin di-potassium (Tookad®; Steba Biotech), a minimally invasive photodynamic therapy for localized prostate cancer, citing concerns that men with very low-risk disease would potentially choose this therapy instead of active surveillance, despite the unproven long-term benefits and harms of treatment.

Magnetic Nanoparticles

MagForce® USA, Inc. is conducting a clinical study evaluating NanoTherm® under an FDA Investigational Device Exemption(IDE) (NCT05010759). NanoTherm uses magnetic nanoparticles and an alternating magnetic field to create heat and localablation in the ablation of prostate cancer.

BENEFIT APPLICATION:

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.  

CURRENT CODING: 

CPT Codes:

53899	unlisted procedure, urinary system
55880	Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance (Effective 01/01/2021)
55899	unlisted procedure, male genital system

0655T	Transperineal focal laser ablation of malignant prostate tissue, including transrectal imaging guidance, with MR-fused images or other enhanced ultrasound imaging (Effective 07/01/21)
0738T	Treatment planning for magnetic field induction ablation of malignant prostate tissue, using data from previously performed magnetic resonance imaging (MRI) examination (Effective 01/01/2023)
0739T	Ablation of malignant prostate tissue by magnetic field induction, including all intraprocedural, transperinealneedle/catheter placement for nanoparticle installation and intraprocedural temperature monitoring,thermal dosimetry, bladder irrigation, and magnetic field nanoparticle activation (Effective 01/01/2023)

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59. Valerio M, Ahmed HU, Emberton M, et al. The role of focal therapy in the management of localised prostate cancer: a systematic review. Eur Urol. Oct 2014; 66(4):732-751.
60. van den Bos W, Muller BG, Ahmed H, et al. Focal therapy in prostate cancer: international multidisciplinary consensus on trial design. Eur Urol. Jun 2014; 65(6):1078-1083.
61. Ward JF, Jones JS. Focal cryotherapy for localized prostate cancer: a report from the national Cryo On-Line Database (COLD) Registry. BJU Int. Jun 2012; 109(11):1648-1654.
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POLICY HISTORY:

Medical Policy Group August 2009 (from MP# 384)

Medical Policy Administration Committee, September 2009 (from MP# 384)

Available for comment September 18-November 2, 2009 (from MP# 384)

Medical Policy Panel, April 2015

Medical Policy Group, April 2015 (4): Adopted policy from the Association. Creation of individual policy, with all information related to focal cryoablation of prostate removed from Description, Policy, Key Points, References and History in MP# 384. Policy statement unchanged. References removed from MP# 384 added to this policy.

Medical Policy Administration Committee, May 2015

Available for comment May 2 through June 15, 2015

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4): Updates to Description, Key Points, Coding and References.  No change to policy statement. Added CPT code 55899 to coding section.

Medical Policy Group, June 2016 (4): Update to Key Points. Update to Practice Guidelines and Position Statements.

Medical Policy Panel, September 2016

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

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (4): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Panel, September 2018

Medical Policy Group, October 2018 (4): Updates to Description, Key Points, Governing Bodies and References. No change to policy statement.

Medical Policy Panel, September 2019

Medical Policy Group, September 2019 (5): Updates to Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (5): Updates to Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Group, November 2020: 2021 Annual Coding Update. Added CPT 55880 to the Current Coding section.

Medical Policy Group, June 2021: Quarterly coding update.  Added code 0655T to Current Coding. Added Key Word Tranberg Thermal Therapy System.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

 

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.