Policy title: Focal Treatments for Prostate Cancer (Formerly Treatments of the Prostate (Focal, Water Vapor, and Hydrogel Spacer))

Policy number: MA 4.043

Effective date: 10/1/2026

Policy

Use of any focal therapy modality to treat individuals with localized prostate cancer is investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

This medical policy applies to Medicare Advantage plans offered by Capital Blue Cross and its subsidiaries.

Cross-References

• MA 1.147 Prostatic Urethral Lift
• MA 1.164 Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia
• MP 4.053 Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy
• MP 4.054 Hydrogel Spacer Use During Radiotherapy for Prostate Cancer
• MA 5.053 Magnetic Resonance-Guided Focused Ultrasound

Description/Background

Prostate Cancer

Prostate cancer is the second most common cancer diagnosed among men in the U.S. According to the American Cancer Society, nearly 333,830 new cases are estimated to be diagnosed in the U.S. in 2026, associated with around 36,320 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. The prostate cancer death rate declined by about half from 1993 to 2022, likely due to earlier detection and improved treatment.

Focal Treatments for Localized Prostate Cancer

Given significant uncertainty in predicting the behavior of individual localized prostate cancers, and the substantial adverse events 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 surgery 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 any 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.

Modalities Used to Ablate Lesions

The following ablative methods for which clinical evidence is available are considered herein: focal laser ablation; high-intensity focused ultrasound (HIFU); cryoablation; radiofrequency ablation (RFA); photodynamic therapy and irreversible electroporation. 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.

Regulatory Status

Focal Laser Ablation

In 2010, the Visualase^® Thermal Therapy System (Medtronic) and, in 2015, the TRANBERG^® CLS|Laser fiber (Clinical Laserthermia Systems) were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under MRI guidance for multiple indications including urology, at wavelengths from 800 to 1064 nm. In 2020, the FDA cleared the Avenda Health focal laser ablation system and in 2021, the FDA granted a breakthrough device designation for the Avenda artificial intelligence (AI)-enabled focal therapy system for the treatment of localized prostate cancer. In 2023, FDA cleared the Elesta Laser Thermal Therapy Kit to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery including urology, at a wavelength of 1064nm. FDA product code: LLZ, GEX, FRN.

High-Intensity Focused Ultrasound

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 classification 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 U.S. In November 2015, Ablatherm^®-HIFU (EDAP TMS) was cleared for marketing by the 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.

Cryoablation

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

Radiofrequency Ablation

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

Photodynamic Therapy

The FDA has granted approval to several photosensitizing drugs and light applicators. porfimer sodium (Photofrin^®; Axcan Pharma) and psoralen are photosensitizer ultraviolet lamps used to treat cancer; they were cleared for marketing by the 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 local ablation in the ablation of prostate cancer.

Irreversible electroporation

The NanoKnife System was cleared through the 510(k) process (K102329) in 2011 for the surgical ablation of soft tissue. NanoKnife has not received clearance for the treatment of any specific disease.

Rationale

For individuals who have primary localized prostate cancer who receive focal therapy using laser ablation, high-intensity focused ultrasound, cryoablation, radiofrequency ablation, or photodynamic therapy, the evidence includes a high-quality systematic review, studies from a registry cohort, and numerous observational studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The evidence is highly heterogeneous and inconsistently reports clinical outcomes. No prospective, comparative evidence was found for focal ablation techniques vs 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 overall survival rates. The adverse event rates associated with focal therapies appear to be superior to those associated with radical treatments (e.g., radical prostatectomy, external-beam radiotherapy); however, the evidence is limited in its quality, reporting, and scope. The evidence is insufficient to determine the effects of the technology on health outcomes.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes is not exhaustive and may change from time to time as permitted by law or applicable clinical guidelines. The inclusion of a code in this section is not a guarantee of coverage or payment. In addition, not all covered services are eligible for separate reimbursement.

Investigational when used to describe Focal Treatments for Prostate Cancer

^*Could be used for focal therapy for cryoablation, radiofrequency ablation, or photodynamic therapy

References

1. American Cancer Society. Key statistics for prostate cancer. January 13, 2026. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed January 21, 2026.
2. Dall'Era MA, Cooperberg MR, Chan JM, et al. Active surveillance for early-stage prostate cancer: review of the current literature. Cancer. Apr 15 2008; 112(8): 1650-9. PMID 18306379
3. Jácome-Pita F, Sánchez-Salas R, Barret E, et al. Focal therapy in prostate cancer: the current situation. Ecancermedicalscience. 2014; 8: 435. PMID 24944577
4. Nguyen CT, Jones JS. Focal therapy in the management of localized prostate cancer. BJU Int. May 2011; 107(9): 1362-8. PMID 21223478
5. Lindner U, Lawrentschuk N, Schatloff O, et al. Evolution from active surveillance to focal therapy in the management of prostate cancer. Future Oncol. Jun 2011; 7(6): 775-87. PMID 21675840
6. Iberti CT, Mohamed N, Palese MA. A review of focal therapy techniques in prostate cancer: clinical results for high-intensity focused ultrasound and focal cryoablation. Rev Urol. 2011; 13(4): e196-202. PMID 22232569
7. Lecornet E, Ahmed HU, Moore CM, et al. Conceptual basis for focal therapy in prostate cancer. J Endourol. May 2010; 24(5): 811-8. PMID 20443699
8. Muto S, Yoshii T, Saito K, et al. Focal therapy with high-intensity-focused ultrasound in the treatment of localized prostate cancer. Jpn J Clin Oncol. Mar 2008; 38(3): 192-9. PMID 18281309
9. Kasivisvanathan V, Emberton M, Ahmed HU. Focal therapy for prostate cancer: rationale and treatment opportunities. Clin Oncol (R Coll Radiol). Aug 2013; 25(8): 461-73. PMID 23759249
10. Liu W, Laitinen S, Khan S, et al. Copy number analysis indicates monoclonal origin of lethal metastatic prostate cancer. Nat Med. May 2009; 15(5): 559-65. PMID 19363497
11. Ahmed HU, Emberton M. Active surveillance and radical therapy in prostate cancer: can focal therapy offer the middle way?. World J Urol. Oct 2008; 26(5): 457-67. PMID 18704441
12. 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): 1078-83. PMID 24444476
13. National Institute for Health and Care Excellence (NICE). Prostate cancer: diagnosis and management. [NG131]. 2019 (updated 2021); https://www.nice.org.uk/guidance/ng131/chapter/Recommendations. Accessed January 20, 2026.
14. National Institute for Health and Care Excellence (NICE). Focal Therapy Using High-Intensity Focused Ultrasound for Localized Prostate Cancer [IPG756]. 2023; https://www.nice.org.uk/guidance/ipg756. Accessed January 21, 2026.
15. Bangma CH, Roemeling S, Schröder FH. Overdiagnosis and overtreatment of early detected prostate cancer. World J Urol. Mar 2007; 25(1): 3-9. PMID 17364211
16. Johansson JE, Andrén O, Andersson SO, et al. Natural history of early, localized prostate cancer. JAMA. Jun 09 2004; 291(22): 2713-9. PMID 15187052
17. Ploussard G, Epstein JI, Montironi R, et al. The contemporary concept of significant versus insignificant prostate cancer. Eur Urol. Aug 2011; 60(2): 291-303. PMID 21601982
18. Harnden P, Naylor B, Shelley MD, et al. The clinical management of patients with a small volume of prostatic cancer on biopsy: what are the risks of progression? A systematic review and meta-analysis. Cancer. Mar 01 2008; 112(5): 971-81. PMID 18186496
19. Brimo F, Montironi R, Egevad L, et al. Contemporary grading for prostate cancer: implications for patient care. Eur Urol. May 2013; 63(5): 892-901. PMID 23092544
20. Eylert MF, Persad R. Management of prostate cancer. Br J Hosp Med (Lond). Feb 2012; 73(2): 95-9. PMID 22504752
21. Eastham JA, Kattan MW, Fearn P, et al. Local progression among men with conservatively treated localized prostate cancer: results from the Transatlantic Prostate Group. Eur Urol. Feb 2008; 53(2): 347-54. PMID 17544572
22. Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. May 12 2005; 352(19): 1977-84. PMID 15888698
23. Thompson IM, Goodman PJ, Tangen CM, et al. Long-term survival of participants in the prostate cancer prevention trial. N Engl J Med. Aug 15 2013; 369(7): 603-10. PMID 23944298
24. Albertsen PC, Hanley JA, Fine J. 20-year outcomes following conservative management of clinically localized prostate cancer. JAMA. May 04 2005; 293(17): 2095-101. PMID 15870412
25. Tay KJ, Mendez M, Moul JW, et al. Active surveillance for prostate cancer: can we modernize contemporary protocols to improve patient selection and outcomes in the focal therapy era?. Curr Opin Urol. May 2015; 25(3): 185-90. PMID 25768694
26. Passoni NM, Polascik TJ. How to select the right patients for focal therapy of prostate cancer?. Curr Opin Urol. May 2014; 24(3): 203-8. PMID 24625428
27. Scales CD, Presti JC, Kane CJ, et al. Predicting unilateral prostate cancer based on biopsy features: implications for focal ablative therapy--results from the SEARCH database. J Urol. Oct 2007; 178(4 Pt 1): 1249-52. PMID 17698131
28. Mouraviev V, Mayes JM, Sun L, et al. Prostate cancer laterality as a rationale of focal ablative therapy for the treatment of clinically localized prostate cancer. Cancer. Aug 15 2007; 110(4): 906-10. PMID 17587207
29. Mouraviev V, Mayes JM, Madden JF, et al. Analysis of laterality and percentage of tumor involvement in 1386 prostatectomized specimens for selection of unilateral focal cryotherapy. Technol Cancer Res Treat. Apr 2007; 6(2): 91-5. PMID 17375971
30. Mouraviev V, Villers A, Bostwick DG, et al. Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int. Oct 2011; 108(7): 1074-85. PMID 21489116
31. Mouraviev V, Mayes JM, Polascik TJ. Pathologic basis of focal therapy for early-stage prostate cancer. Nat Rev Urol. Apr 2009; 6(4): 205-15. PMID 19352395
32. Guo CC, Wang Y, Xiao L, et al. The relationship of TMPRSS2-ERG gene fusion between primary and metastatic prostate cancers. Hum Pathol. May 2012; 43(5): 644-9. PMID 21937078
33. Stamey TA, Freiha FS, McNeal JE, et al. Localized prostate cancer. Relationship of tumor volume to clinical significance for treatment of prostate cancer. Cancer. Feb 01 1993; 71(3 Suppl): 933-8. PMID 7679045
34. Nelson BA, Shappell SB, Chang SS, et al. Tumour volume is an independent predictor of prostate-specific antigen recurrence in patients undergoing radical prostatectomy for clinically localized prostate cancer. BJU Int. Jun 2006; 97(6): 1169-72. PMID 16686706
35. Mayes JM, Mouraviev V, Sun L, et al. Can the conventional sextant prostate biopsy accurately predict unilateral prostate cancer in low-risk, localized, prostate cancer?. Urol Oncol. 2011; 29(2): 166-70. PMID 19451000
36. Sinnott M, Falzarano SM, Hernandez AV, et al. Discrepancy in prostate cancer localization between biopsy and prostatectomy specimens in patients with unilateral positive biopsy: implications for focal therapy. Prostate. Aug 01 2012; 72(11): 1179-86. PMID 22161896
37. Gallina A, Maccagnano C, Suardi N, et al. Unilateral positive biopsies in low risk prostate cancer patients diagnosed with extended transrectal ultrasound-guided biopsy schemes do not predict unilateral prostate cancer at radical prostatectomy. BJU Int. Jul 2012; 110(2 Pt 2): E64-8. PMID 22093108
38. Briganti A, Tutolo M, Suardi N, et al. There is no way to identify patients who will harbor small volume, unilateral prostate cancer at final pathology. implications for focal therapies. Prostate. Jun 01 2012; 72(8): 925-30. PMID 21965006
39. Arumainayagam N, Ahmed HU, Moore CM, et al. Multiparametric MR imaging for detection of clinically significant prostate cancer: a validation cohort study with transperineal template prostate mapping as the reference standard. Radiology. Sep 2013; 268(3): 761-9. PMID 23564713
40. Dickinson L, Ahmed HU, Allen C, et al. Magnetic resonance imaging for the detection, localisation, and characterisation of prostate cancer: recommendations from a European consensus meeting. Eur Urol. Apr 2011; 59(4): 477-94. PMID 21195536
41. Lee T, Mendhiratta N, Sperling D, et al. Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014; 16(2): 55-66. PMID 25009445
42. Borley N, Feneley MR. Prostate cancer: diagnosis and staging. Asian J Androl. Jan 2009; 11(1): 74-80. PMID 19050692
43. Freedland SJ. Screening, risk assessment, and the approach to therapy in patients with prostate cancer. Cancer. Mar 15 2011; 117(6): 1123-35. PMID 20960523
44. Ip S, Dahabreh IJ, Chung M, et al. An evidence review of active surveillance in men with localized prostate cancer. Evidence Report/Technology Assessment no. 204 (AHRQ Publication No. 12-E003-EF). Rockville, MD: Agency for Research and Quality; 2011.
45. American Urological Association. Guideline for management of clinically localized prostate cancer: 2007 update. Linthicum, MD: American Urological Association Education and Research; 2007.
46. Eastham JA, Auffenberg GB, Barocas DA, et al. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline. 2022; https://www.auanet.org/guidelines/guidelines/clinically-localized-prostate-cancer-aua/astro-guideline-2022. Accessed January 21, 2026.
47. Whitson JM, Carroll PR. Active surveillance for early-stage prostate cancer: defining the triggers for intervention. J Clin Oncol. Jun 10 2010; 28(17): 2807-9. PMID 20439633
48. Albertsen PC. Treatment of localized prostate cancer: when is active surveillance appropriate?. Nat Rev Clin Oncol. Jul 2010; 7(7): 394-400. PMID 20440282
49. Muller BG, van den Bos W, Brausi M, et al. Follow-up modalities in focal therapy for prostate cancer: results from a Delphi consensus project. World J Urol. Oct 2015; 33(10): 1503-9. PMID 25559111
50. American Urological Association (AUA). A Randomized Clinical Trial Comparing Focal Ablation And Radical Prostatectomy In Patients With Unilateral Clinically Significant Prostate Cancer. Intention To Treat Analysis At Two-Year Follow-Up (Pd39-06). Published May 2024. https://www.auajournals.org/doi/10.1097/01.JU.0001008924.16121.42.06. Accessed January 21, 2026.
51. Azzouzi AR, Vincendeau S, Barret E, et al. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. Feb 2017; 18(2): 181-191. PMID 28007457
52. 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. Jun 2021; 4(3): 405-423. PMID 33423943
53. Hopstaken JS, Bomers JGR, Sedelaar MJP, et al. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years?. Eur Urol. Jan 2022; 81(1): 5-33. PMID 34489140
54. Polverino P, Lo Re M, Moscardi L, et al. Transperineal Focal Laser Ablation of the Prostate for Prostate Cancer: A Systematic Review of the Literature. Cancers (Basel). Mar 13 2025; 17(6). PMID 40149303
55. Tay KJ, Fong KY, Stabile A, et al. Established focal therapy-HIFU, IRE, or cryotherapy-where are we now?-a systematic review and meta-analysis. Prostate Cancer Prostatic Dis. Sep 2025; 28(3): 693-706. PMID 39468217
56. Wang CJ, Pang CC, Qin J, et al. Comparative study of HIFU partial gland ablation and robot-assisted radical prostatectomy for localized prostate cancer: an evidence-based approach. J Robot Surg. Oct 14 2024; 18(1): 367. PMID 39402287
57. Zhu A, Strasser MO, McClure TD, et al. Comparative Effectiveness of Partial Gland Cryoablation Versus Robotic Radical Prostatectomy for Cancer Control. Eur Urol Focus. Sep 2024; 10(5): 843-850. PMID 38677913
58. Ploussard G, Coloby P, Chevallier T, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. May 2025; 87(5): 526-533. PMID 39632125
59. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2026. NCCN Prostate Cancer Guidelines. Accessed January 13, 2026.
60. National Cancer Institute. Prostate Cancer Treatment (PDQ) Patient Version: Treatment Option Overview. 2024. Prostate Cancer Treatment (PDQ). Accessed January 21, 2026.
61. U.S. Preventive Services Task Force. Final Recommendation Statement: Prostate Cancer: Screening. 2018; https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/prostate-cancer-screening. Accessed January 21, 2026.

Policy History

• MA 4.043
• 9/30/2025 Partial adoption of commercial policy.
• 04/01/2026 Minor review. Title change. Statements and procedure codes for BPH have been moved to MA 4.053. Statements and procedure codes for Hydrogel Spacer have been moved to MA 4.054. 0950T will be moved to MA 4.002 E/I.

Plans issued by Capital Blue Cross and it’s subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.