DESCRIPTION
The behavior of localized prostate cancer can prove difficult to predict on a case-by-case basis. Most men with prostate cancer undergo whole-gland treatments, which can often lead to substantial adverse events. 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 non-index lesions and other areas where cancer has been known to occur. Several ablative methods have been proposed to remove cancerous lesions in localized prostate cancer (eg, 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.
Focal laser ablation refers to the destruction of tissue using a focused beam of electromagnetic radiation emitted from a laser fiber introduced transperineally or transrectally into the cancer focus. The tissue is destroyed through the thermal conversion of the focused electromagnetic energy into heat, causing coagulative necrosis. Other terms for focal laser ablation include photothermal therapy, laser interstitial therapy, and laser interstitial photocoagulation. Examples of FDA approved devices include Visualase® Thermal Therapy System, TRANBERG® CLS|Laser fiber, and Avenda® Health Focal Therapy System.
POLICY
Magnetic resonance imaging (MRI) guided focal ablation for the treatment of prostate cancer is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
SOURCES
American Urological Association. (2022). Clinically Localized Prostate Cancer: AUA/ASTRO Guideline (2022) Endorsed by SUO. Retrieved May 23, 2023 from https://www.auanet.org/guidelines-and-quality/guidelines/clinically-localized-prostate-cancer-aua/astro-guideline-2022.
BlueCross BlueShield Association. Evidence Positioning System. (10:2022). Focal Treatments for Prostate Cancer (8.01.61). Retrieved May 16, 2023 from https://www.bcbsaoca.com/eps/. (66 articles and/or guidelines reviewed)
Chao, B., & Lepor, H. (2021). 5-Year outcomes following focal laser ablation of prostate cancer. Urology, 155, 124–129. Abstract retrieved May 18, 2023 from PubMed database.
Hopstaken, J., Bomers, J., Sedelaar, M., Valerio, M., Fütterer, J., & Rovers, M. (2022). An updated systematic review on focal therapy in localized prostate cancer: What has changed over the past 5 years? European Urology, 81 (1), 5–33. (Level 2 evidence)
Lepor, H., Llukani, E., Sperling, D., & Fütterer, J. (2015). Complications, Recovery, and Early Functional Outcomes and Oncologic Control Following In-bore Focal Laser Ablation of Prostate Cancer. European Urology, 68 (6), 924–926. Abstract retrieved May 17, 2023 from PubMed database.
Mehralivand, S., George, A., Hoang, A., Rais-Bahrami, S., Rastinehad, A., Lebastchi, A., et al. (2021). MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up. Diagnostic and Interventional Radiology (Ankara, Turkey), 27 (3), 394–400. (Level 4 evidence)
Natarajan, S., Raman, S., Priester, A., Garritano, J., Margolis, D., Lieu, P., et al. (2016). Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. The Journal of Urology, 196 (1), 68–75. Abstract retrieved May 17, 2023 from PubMed database.
National Comprehensive Cancer Network. (2022, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate cancer v.1.2023. Retrieved May 16, 2023 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2007, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071328. Retrieved May 17, 2023 from https://www.accessdata.fda.gov/cdrh_docs/pdf7/K071328.pdf.
U. S. Food and Drug Administration. (2015, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K142216. Retrieved May 17, 2023 from https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142216.pdf.
U. S. Food and Drug Administration. (2022, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K221624. Retrieved May 17, 2023 from https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221624.pdf.
Walser, E., Nance, A., Ynalvez, L., Yong, S., Aoughsten, J., Eyzaguirre, E., et al. (2019). Focal laser ablation of prostate cancer: Results in 120 patients with low- to intermediate-risk disease. Journal of Vascular and Interventional Radiology: JVIR, 30 (3), 401–409. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 9/30/2023
MOST RECENT REVIEW DATE: 9/30/2023
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