Medical Policy

This document addresses the use of focal laser ablation, a device-based thermal ablative therapy used to treat localized prostate cancer. Focal laser ablation (FLA) is also known as laser interstitial therapy or laser interstitial photocoagulation. The procedure is frequently performed with real-time magnetic resonance imaging (MRI) which also allows the use of magnetic resonance (MR) thermometry to monitor the lesion and surrounding tissue during treatment. This treatment can be delivered to part of the prostate (index lesion, hemigland, or subtotal volume) or to the whole gland. It is addressed in clinical practice guidelines within the broader class of focal therapies for localized prostate cancer.

Note: Please see the following related documents regarding other minimally invasive treatments of prostate cancer:

• CG-MED-81 Ultrasound Ablation for Oncologic Indications
• CG-SURG-61 Cryosurgical, Radiofrequency, Microwave or Laser Ablation to Treat Solid Tumors Outside the Liver

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Focal laser ablation is considered investigational and not medically necessary for the treatment of prostate cancer.

This document describes clinical studies and expert recommendations, and explains why using laser to treat small areas of cancer in the prostate is not considered appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Focal laser ablation (FLA) is a treatment that uses heat from a laser  device to destroy a part of the prostate that has cancer. Doctors sometimes use an MRI to see the spot clearly and watch the temperature during the procedure. The goal is to kill the cancer while protecting nearby tissues such as nerves, bladder, or the tube that carries urine out of the body (urethra).

This is one of several “focal therapies” for early prostate cancer, but it is not a standard treatment. Studies do not show that it works as well as other types of surgery or radiation. It also has risks, such as the cancer coming back and problems with sexual function. Because of these concerns, nationally respected  medical groups say it should be used only in research studies (clinical trials).

What the Studies Show

Research on FLA is limited and has mostly been done in small groups at single hospitals without fair comparisons to other treatments. These studies report that many people still had cancer after the procedure. In some studies, between 17% and 49% of people had cancer return or not go away within 1 year. In one study of people with medium-risk cancer, almost half still had cancer on a biopsy after a year. The cancer often returned in the same place or appeared in new areas.

Results also depended on the tools used. People treated with newer laser tools did better than those treated with older ones. Even with better tools, serious problems still happened, including injury between the rectum and prostate that needed surgery. Some people also had lower sexual health scores after treatment.

When compared to standard care, results were worse. In one study, people who had laser treatment were more likely to die from any cause than those who had surgery. Another study showed worse overall survival compared to radiation, even when older radiation methods were used. These findings suggest the laser treatment may not control cancer as well or help people live as long as they would with more standard treatments.

Is this clinically appropriate?

This treatment is not appropriate at this time because it has not been proven to improve health. Studies show high rates of cancer coming back and worse survival than with surgery or radiation. There are also no strong clinical trials showing that it works as well as standard care. Professional groups recommend using it only in clinical trials. Choosing an unproven treatment can lead to poor results and delays in getting proven care.

(Return to Description/Scope)

Summary

The evidence for focal laser ablation (FLA) in prostate cancer consists exclusively of uncontrolled studies with no published randomized controlled trials (RCTs), limiting confidence in comparative effectiveness. Available studies demonstrate concerning oncologic outcomes, with cancer recurrence rates (RR) ranging from 17% to 49% at 1 year, and comparative analyses showing worse overall survival (OS) compared to established treatments such as radical prostatectomy and radiotherapy. Several professional society guidelines characterize FLA as experimental and recommend its use be restricted to clinical trials, particularly noting the lack of long-term oncologic data and absence of evidence demonstrating superiority or noninferiority to standard management strategies. The totality of evidence suggests that FLA cannot currently be considered standard of care for any risk category of localized prostate cancer.

Discussion

Evidence Quality and Study Design Limitations

No randomized controlled trials (RCTs) evaluating FLA for treating prostate cancer have been published. The published evidence on FLA consists largely of uncontrolled studies, many of which have small sample sizes and limited follow-up (Lee, 2014; Lepor, 2015; Natarajan, 2016; Oto, 2013). There have been some small published studies with longer-term results, however, these studies have been limited by being single institution studies and non-standard protocols, limiting the quality and generalizability of the results (Chao, 2021; Mehralivand, 2021).

In 2023, Nicoletti and colleagues published a systematic review of uncontrolled studies evaluating focal therapy for prostate cancer. No controlled studies evaluating FLA were identified. There were 10 single-arm studies, with a total of 308 participants. The authors did not pool study findings and did not report an assessment of the risk of bias for individual studies. Significant heterogeneity in surgical techniques, outcome definitions, and observation time periods limit the strength of this study’s findings.

Oncologic Outcomes and Treatment Failure Rates

Available prospective studies demonstrate consistently high rates of cancer persistence and recurrence following FLA. At 1 year following treatment, studies report that 17% to 49% of individuals demonstrate evidence of cancer recurrence or persistence. Walser and colleagues (2019) reported that 17% of individuals with low to intermediate-risk prostate cancer (n=120) required additional oncologic treatment within 1 year, with all recurrences occurring at ablation margins or the prior treatment site; in a subset with larger treatment margins (n=16), only 6.8% had clinically significant residual tumor at 1 year. More recent studies have documented substantially higher failure rates. Maiolino and colleagues (2025) found that 47% of individuals (n=30) with intermediate-risk disease had detectable prostate cancer on biopsy at 1 year, including 17% with clinically significant cancer (International Society of Urological Pathology [ISUP] grade 2 or higher), with recurrences distributed between in-field sites (17%) and new areas outside the treated zone (30%). Similarly, Cornud and associates (2024) observed a 49% overall RR among 35 treated tumors at 12-month follow-up, with 37% demonstrating in-field recurrence.

Technical factors appear to significantly influence treatment outcomes. Cornud and associates (2024) reported results for a small (35 tumors) prospective, single-center, observational pilot study of MRI-guided micro-US transperineal FLA for localized prostate cancer. The authors found markedly different in-field RR between single-fiber ablation (56%) and multifiber ablation (18%). This finding highlights challenges in achieving complete tumor destruction. The same study documented meaningful complications, including one rectoprostatic fistula requiring surgical repair despite hydrodissection. Procedures in this study were performed by a highly experienced radiologist and urologist in a single center. The observed results may not reflect performance in typical community settings. The lack of a control group prevents conclusions from being drawn about FLA’s effectiveness compared to currently recommended treatments.

These findings indicate both incomplete cancer control and non-trivial complication risk. Across studies, methodological limitations include single institution designs, small sample sizes, non-standardized treatment protocols, variable treatment margins, and limited follow-up duration, with several studies failing to report attrition rates.

Comparative Effectiveness with Established Treatments

Propensity-matched comparative analyses consistently demonstrate inferior survival outcomes for FLA compared to established treatment modalities. When compared to radical prostatectomy, Zheng and associates (2019) found FLA was associated with significantly higher all-cause mortality (hazard ratio [HR], 2.35; 95% confidence interval [CI], 1.38-3.98; p=0.0016) at mean follow-up of approximately 5 years, though cancer-specific mortality differences were not statistically significant (HR, 0.82; 95% CI, 0.18-3.67; p=0.7936) in 321 matched pairs.

Comparison to radiotherapy similarly favored the established treatment. Zhou and colleagues (2020) analyzed results for 428 individuals treated with FLA matched to a radiotherapy cohort (n=93,041) and found that FLA was associated with significantly worse OS in both multivariate analysis (HR, 1.91; 95% CI, 1.51-2.40; p<0.001) and following propensity score matching (HR, 1.50; 95% CI, 1.17-1.93; p=0.001), though cancer-specific mortality did not differ significantly between groups (HR, 1.48; 95% CI, 0.66-3.32; p=0.336). The radiotherapy cohort's survival advantage persisted despite some individuals receiving outdated radiotherapy techniques, given the study included individuals diagnosed between 2004 and 2015. The authors concluded that laser ablation "can only be used as an experimental treatment" until RCTs evaluating clinically relevant objective outcomes are published.

Clinical Practice Guideline Recommendations

Professional society guidelines uniformly characterize FLA as experimental and recommend restricting its use to clinical trials based on the absence of high-quality comparative effectiveness data.

In 2022, an updated American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline was published on clinically localized prostate cancer (Eastham, 2022), which provides the following guidance:

Clinicians should inform patients with intermediate-risk prostate cancer considering whole gland or focal ablation that there is 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)

The National Comprehensive Cancer Network^® (NCCN) clinical practice guidelines for prostate cancer (Version 3, 2026) provide specific principles for focal, subtotal, and whole gland ablative therapies. Focal therapy, including FLA, is characterized as an experimental, emerging technology for the initial treatment of localized prostate cancer that lacks randomized controlled trial evidence with long term follow up demonstrating superiority or noninferiority to established management strategies, and is therefore considered an alternative, nonstandard treatment.

Active surveillance is the preferred management for low risk disease and ablative and focal therapies are discouraged in this group; ablative focal therapy is also discouraged for individuals with high or very high risk, regional, or metastatic disease outside of a clinical trial. For individuals with intermediate risk localized disease, the NCCN states that there is insufficient comparative effectiveness evidence to recommend focal therapy and that ablative and focal therapies, including FLA, should be used only in the context of a clinical trial. FLA is specifically listed among device categories that are not United States Food and Drug Administration (FDA)-approved or cleared for the treatment of prostate cancer and that should only be used in individuals with previously untreated localized disease enrolled in clinical trials.

The 2025 European Association of Urology (EAU), European Association of Nuclear Medicine (EANM), European Society for Radiotherapy and Oncology (ESRO), European Society of Urogenital Radiology (ESUR), International Society of Urological Pathology (ISUP), and International Society of Geriatric Oncology (ISGO) prostate cancer guideline similarly concludes that focal therapy cannot be considered standard of care because robust long term oncologic data are lacking, and recommends that whole gland ablation and focal ablative therapy be restricted to clinical trials or prospective registries in intermediate risk disease and not used outside a trial in low risk disease, where such approaches are considered likely to represent overtreatment.

The American Cancer Society (ACS) estimates about 333,830 new cases and 36,320 deaths from prostate cancer in the U.S. in 2026.

Prostate cancers can be broadly categorized as:

• Localized: Cancer is limited to the prostate;
• Regional: Cancer is limited to the prostate and nearby structures or lymph nodes;
• Distant: Metastatic cancer.

In addition to the broad categories listed above, localized prostate cancer is also stratified by risk assessment. Individual risk level provides prognostic information and guides further diagnostic and therapeutic planning. Prostate cancer risk levels are characterized by the results of digital rectal exam, the clinical T stage, Gleason score, extent of cancer and serum PSA levels. The NCCN (V3. 2026) stratifies risk into 5 levels: very low, low, intermediate, high and very high. An estimated 74% of all cases of prostate cancer are categorized as low or intermediate risk (Zhou, 2020). Generally, active surveillance is recommended for individuals with localized disease who are in the very low and low risk groups (Stabile, 2019). However, approximately 94% of individuals diagnosed with low-risk cancers undergo radical treatment, such as radiation or surgery (Colin, 2012). These treatments are associated with long term quality of life issues, such as incontinence and impotence. Focal therapy has been proposed as an alternative to active surveillance and surgery or radiation.

FLA therapy is a type of focal therapy which involves the destruction of prostate tissue while preserving surrounding tissue and structures, such as neurovascular bundles, bladder neck, and urethral sphincter (Zheng, 2019). The laser uses coagulative necrosis to remove targeted tissue and avoids cavitation, carbonization or vaporization (Natarajan, 2016). Prostate cancer is multifocal in up to 75% of all cases (Stabile, 2019). Treatment can involve the destruction of multiple lesions within the prostate or a significant single index lesion. It has been proposed that the index lesion, which is associated with the most aggressive nidus of cancer within the prostate gland, drives the natural course of disease. Focal therapy can also be used to ablate half of the gland containing the tumor (hemi-ablation) or ablate a volume greater than half of the prostate (sub-total ablation) (Stabile, 2019). In addition to the lack of demonstrable oncologic efficacy, there are additional concerns related to the use of FLA. Focal therapy is susceptible to multiple technical errors, such as poor navigation, inadequate imaging or imprecise tissue destruction, which increases the risk of incomplete tumor tissue ablation (Zheng, 2019; Zhou, 2020).

The FDA cleared the Visualase^® Thermal Therapy System (Medtronic, Minneapolis, MN) in 2007. The device is indicated for use in necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy under MRI guidance. A more recent version of the device, cleared in 2008, allowed for better temperature control limits to be set.

In 2015, the FDA cleared the Tranberg Thermal Therapy System (Clinical Laserthermia Systems AB, Irvine, CA) for marketing. According to the FDA, the device is indicated for “surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery…”. There was not a specific clearance or approval for treatment of prostate cancer.

Focal therapy: The use of ablative techniques, such as laser, to destroy a predefined area of tissue with minimal damage to surrounding tissue.

Index lesion: the dominant cancer focus within the prostate, typically characterized by the highest histologic grade and/or greatest tumor volume, and is considered the primary determinant of the individual’s overall disease risk. It is generally the lesion most conspicuous on imaging and most strongly associated with the biological behavior and potential progression of localized prostate cancer.

Initial Risk Stratification for Clinically Localized Disease*

* Source. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Prostate Cancer V3.2026. Abbreviations. cT: clinical T category based on clinical assessment; grade group: A system for grading prostate cancer tissue based on microscopic appearance (Gleason patterns), ranging from 1 (least aggressive) to 5 (most aggressive); IRF: intermediate risk factor; ng/mL: nanograms per milliliter (unit of measurement for PSA concentration); PSA: prostate-specific antigen; T1: tumor that is clinically inapparent, not palpable or visible by imaging.; T2a: tumor involves one-half of one lobe or less of the prostate; T2b: tumor involves more than one-half of one lobe but not both lobes of the prostate; T2c: tumor involves both lobes of the prostate; T3: tumor extends through the prostatic capsule (extraprostatic extension); T3b: tumor invades the seminal vesicle(s); T4: tumor is fixed or invades adjacent structures other than the seminal vesicles (e.g., external sphincter, rectum, bladder, levator muscles, and/or pelvic wall).

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure and diagnosis codes; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Bates AS, Ayers J, Kostakopoulos N, et al. A systematic review of focal ablative therapy for clinically localised prostate cancer in comparison with standard management options: limitations of the available evidence and recommendations for clinical practice and further research. Eur Urol Oncol. 2021; 4(3):405-423.
2. Chao B, Lepor H. 5-year outcomes following focal laser ablation of prostate cancer. Urology. 2021; 155:124-129.
3. Colin P, Mordon S, Nevoux P, et al. Focal laser ablation of prostate cancer: definition, needs, and future. Adv Urol. 2012; 2012:589160.
4. Cornud F, de Bie K, van Riel L, et al. MRI-directed micro-US-guided transperineal focal laser ablation for localized prostate cancer: a 1-year follow-up study. Radiology. 2024; 313(3):e233371.
5. Eggener SE, Yousuf A, Watson S, et al. Phase II evaluation of magnetic resonance imaging guided focal laser ablation of prostate cancer. J Urol. 2016; 196(6):1670-1675.
6. Lee T, Mendhiratta N, Sperling D, Lepor H. Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014; 16(2):55-66.
7. Lepor H, Llukani E, Sperling D, Fütterer JJ. Complications, recovery, and early functional outcomes and oncologic control following in-bore focal laser ablation of prostate cancer. Eur Urol. 2015; 68(6):924-926.
8. Maiolino G, Lopez-Prieto A, Egui-Benatuil G, et al. Transperineal MR fusion laser ablation of prostate cancer in office setting: 1-year efficacy and safety outcomes in intermediate-risk patients. J Endourol. 2025; 39 (Suppl 2):S13-S20.
9. Mehralivand S, George AK, Hoang AN, et al. MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up. Diagn Interv Radiol. 2021; 27(3):394-400.
10. Natarajan S, Raman S, Priester AM, et al. Focal laser ablation of prostate cancer: Phase I clinical trial. J Urol. 2016; 196(1):68-75.
11. Nicoletti R, Alberti A, Castellani D, et al. Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs). Prostate Cancer Prostatic Dis. 2024; 27(4):614-622.
12. Oto A, Sethi I, Karczmar G, et al. MR imaging-guided focal laser ablation for prostate cancer: phase I trial. Radiology. 2013; 267(3):932-940.
13. Stabile A, Moschini M, Montorsi F, et al. Focal therapy for prostate cancer - index lesion treatment vs. hemiablation. A matter of definition. Int Braz J Urol. 2019; 45(5):873-876.
14. Walser E, Nance A, Ynalvez L, et al. Focal laser ablation of prostate cancer: Results in 120 patients with low- to intermediate-risk disease. J Vasc Interv Radiol. 2019; 30(3):401-409.
15. Zheng X, Jin K, Qiu S, et al. Focal laser ablation versus radical prostatectomy for localized prostate cancer: Survival outcomes from a matched cohort. Clin Genitourin Cancer. 2019; 17(6):464-469.e3.
16. Zhou X, Jin K, Qiu S, et al. Comparative effectiveness of radiotherapy versus focal laser ablation in patients with low and intermediate risk localized prostate cancer. Sci Rep. 2020; 10(1):9112.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Cancer Society. 2026. Key Statistics for Prostate Cancer. Last Revised: January 13, 2026. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed on March 2, 2026.
2. Cornford P, Tilki D, van den Bergh RCN, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on prostate cancer - 2025 Update. European Association of Urology; 2025. Available at: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Guidelines-on-Prostate-Cancer-2025_updated.pdf. Accessed February 1, 2026.
3. Eastham JA, Auffenberg GB, Barocas DA, et al. Clinically Localized Prostate Cancer: AUA/ASTRO guideline, Part I: introduction, risk assessment, staging, and risk-based management. Journal of Urology. 2022; 208(1):10-18.
4. NCCN Clinical Practice Guidelines in Oncology^®. ^©2025 National Comprehensive Cancer Network, Inc. Prostate Cancer V3. 2026. Last review November 7, 2025. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on February 1, 2026.
5. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Visualase Thermal Therapy System. 510K Summary/ No. K071328. Rockville, MD: FDA. August 31, 2007. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K071328.pdf. Accessed on February 1, 2026.

1. Centers for Disease Control and Prevention. Prostate Cancer. Available at: https://www.cdc.gov/cancer/prostate/index.htm. Accessed on February 1, 2026.
2. National Institute of Health. National Cancer Institute. Lasers to treat cancer. Updated June 16, 2021. Available at: https://www.cancer.gov/about-cancer/treatment/types/surgery/lasers-fact-sheet. Accessed on February 1, 2026.
3. U.S. National Library of Medicine. Medline Plus. Prostate cancer. Last updated March 28, 2024. Available at: https://medlineplus.gov/prostatecancer.html. Accessed on February 1, 2026.

Ablation, focal laser
Prostate cancer
Tranberg Thermal Therapy System
Visualase Thermal Therapy System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.