Treatments of the Prostate (Focal, Water Vapor, and Hydrogel Spacer)

Policy Number: MA 4.043

Effective Date: 2/1/2026

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.

Transurethral Water Vapor Thermal Therapy

Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Hydrogel Rectal Spacer

Hydrogel Rectal Spacer is considered investigational for all indications. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-References

• MA 1.147 Prostatic Urethral Lift
• MA 1.164 Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia
• MA 5.053 Magnetic Resonance-Guided Focused Ultrasound

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Focal Treatments

Prostate Cancer

Prostate cancer is the second most common cancer diagnosed among men in the U.S. with over 1 in 10 men diagnosed with prostate cancer over their lifetime According to the National Cancer Institute, nearly 288,300 new cases are estimated to be diagnosed in the U.S. in 2023, associated with around 34,700 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.

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.

Transurethral Water Vapor Thermal Therapy

Benign prostatic hyperplasia (BPH) is a common condition in older men, affecting to some degree 40% of men in their 50s, 70% of those between ages 60 and 69, and almost 80% of those ages 70 years and older. Benign prostatic hyperplasia is a histologic diagnosis defined as an increase in the total number of stromal and glandular epithelial cells within the transition zone of the prostate gland. In some men, BPH results in prostate enlargement which can, in turn, lead to benign prostate obstruction and bladder outlet obstruction, which are often associated with lower urinary tract symptoms (LUTS) including urinary frequency, urgency, irregular flow, weak stream, straining, and waking up at night to urinate. Lower urinary tract symptoms are the most commonly presenting urological complaint and can have a significant impact on quality of life.

Benign prostatic hyperplasia does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. Options for medical treatment include alpha-1-adrenergic antagonists, 5-alpha-reductase inhibitors, anticholinergic agents, and phosphodiesterase-5 inhibitors. Medications may be used as monotherapy or in combination.

Patients with persistent symptoms despite medical treatment may be considered for surgical treatment. The traditional standard treatment for BPH is transurethral resection of the prostate (TURP). Transurethral resection of the prostate is generally considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have also been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate.

Transurethral water vapor thermal therapy has been investigated as minimally invasive alternatives to TURP. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue.

Regulatory Status

In September 2016, the Rezum™ System (NxThera, Inc, acquired by Boston Scientific in 2018) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K150786). The FDA determined that this device was substantially equivalent to existing devices (Medtronic Prostiva devices). Rezum is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men >50 years of age with a prostate volume >30 cm3 and <80 cm3. The Rezum System is also indicated for the treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Hydrogel Spacer

Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors unlikely to be life-threatening to aggressive tumors that can metastasize, leading to morbidity or death. It is the second most common cancer in men, with approximately 1 in 8 men diagnosed with prostate cancer over their lifetime. Cancer is typically suspected due to increased levels of prostate-specific antigen upon screening. A digital rectal exam may detect nodules, induration, or asymmetry, which is then followed by an ultrasound-guided biopsy with an evaluation of the number and grade of positive biopsy cores.

Clinical staging is based on the digital rectal exam and biopsy results. T1 lesions are not palpable while T2 lesions are palpable but appear to be confined to the prostate. T3 lesions extend through the prostatic capsule, and T4 lesions are fixed to or invade adjacent structures. The most widely used grading scheme for a prostate biopsy is the Gleason system. It is an architectural grading system ranging from 1 (well-differentiated) to 5 (poorly differentiated); the score is the sum of the primary and secondary patterns. A Gleason score of 6 or less is low-grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-grade cancer that grows more quickly. A revised prostate cancer grading system has been adopted by the National Cancer Institute and the World Health Organization. A cross-walk of these grading systems are shown in Table 1.

Table 1. Prostate Cancer Grading Systems

Regulatory Status

In October 2014, SpaceOAR™ (Augmenix, a subsidiary of Boston Scientific) was cleared by the U.S. Food and Drug Administration (FDA) through the De Novo process (DEN140030). Barrigel Injectable Gel (Palette Life Sciences) was approved by the FDA via the premarket approval process in March 2022 (K220641; FDA product code: OVB), followed by BioProtect Balloon Implant™ System (BioProtect, Ltd) in 2023 (K222972; FDA product code: OVB).The intended and approved use of SpaceOAR System, Barrigel, and BioProtect Balloon Implant is to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of these hydrogel spacers to reduce the radiation dose delivered to the anterior rectum.

DuraSeal^® Exact (Integra) was approved by the FDA through the premarket approval process as a spine and cranial sealant (dura mater) and has been used off-label as a perirectal spacer.

Rationale

Summary of Evidence: Focal Treatment

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.

Summary of Evidence: Transurethral Water Vapor Thermal Therapy

For individuals who have benign prostatic hypertrophy (BPH) and lower urinary tract symptoms (LUTS) who receive transurethral water vapor thermal therapy, the evidence includes a single 3-month, sham-controlled, randomized trial of 197 patients with a 5-year uncontrolled follow-up phase and 1 multicenter, prospective, single-arm study. The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. At 3 months, LUTS improved more in the intervention group compared to the sham procedure. No adverse effects on erectile or ejaculatory function were observed, and improvements were sustained through 5 years of follow-up. The evidence is limited by the small sample size, lack of blinding of longer-term outcomes, and lack of comparison to alternative treatments such as transurethral resection of the prostate (TURP). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Summary of Evidence: Hydrogel Spacer

For individuals who have prostate cancer and are undergoing radiation therapy who receive a hydrogel spacer, the evidence includes a pivotal randomized controlled trial (RCT) with a 3-year follow-up for the SpaceOAR system, a pivotal RCT with up to 6-month follow-up for the Barrigel, observational studies, and systematic reviews of these studies. Relevant outcomes include symptoms, quality of life, and treatment-related morbidity. The combined evidence indicates that the hydrogel spacer can reduce the radiation dose to the rectum with a statistically significant decrease in Grade 1 or greater late toxicity and a number needed to treat (NNT) of 14.3. There were few events of greater than Grade 1 toxicity in either group across all trials, and the NNT for a reduction in clinically significant Grade 2 toxicity has been reported as 68 for SpaceOar. Patient-reported declines in rectal and urinary quality of life at 3 years in the SpaceOAR studies were statistically lower in the spacer group and met the threshold for a clinically significant difference, although patients were not blinded to treatment at the longer-term follow-up. The NNT for late improvement in rectal and urinary quality of life was 6.3 to 6.7, respectively, for SpaceOAR analysis. Limitations to all RCTs include the lack of blinding and the exclusion of patients who might be at greater risk of rectal toxicity. Evidence from observational studies is inconclusive but generally shows a decrease in radiation dose to the rectum with the insertion of a hydrogel spacer. However, the potential benefits of the hydrogel spacer must be balanced against the risks of an additional procedure. Additional studies are needed to corroborate the findings of the pivotal RCTs, to identify the factors that increase the risk of rectal toxicity, and to determine who is likely to benefit from the use of a spacer. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices 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 may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Investigational when used to describe Focal Treatments for Prostate Cancer

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

Investigational for radiofrequency water vapor (steam) thermal therapy for BPH

Investigational for Hydrogel Therapy

References

Focal Treatments for Prostate Cancer

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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
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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. Scheltema MJ, van den Bos W, de Bruin DM, et al. Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial. BMC Cancer. May 05 2016; 16: 299. PMID 27150293
43. Borley N, Feneley MR. Prostate cancer: diagnosis and staging. Asian J Androl. Jan 2009; 11(1): 74-80. PMID 19050692
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50. 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
51. George AK, Miocinovic R, Patel AR, et al. A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial. Cancers (Basel). Jun 08 2024; 16(12). PMID 38927884
52. 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
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Transurethral Water Vapor Thermal Therapy

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2. Westwood J, Geraghty R, Jones P, et al. Rezum: a new transurethral water vapour therapy for benign prostatic hyperplasia. Ther Adv Urol. Nov 2018; 10(11): 327-333. PMID 30344644
3. McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. Jan 2018; 111: 1-9. PMID 29122620
4. Kang TW, Jung JH, Hwang EC, et al. Convective radiofrequency water vapour thermal therapy for lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. Mar 25 2020; 3(3): CD013251. PMID 32212174
5. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. May 2016; 195(5): 1529-1538. PMID 26614889
6. McVary KT, Rogers T, Roehrborn CG. Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. Apr 2019; 126: 171-179. PMID 30677455
7. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. Sep 2021; 206(3): 715-724. PMID 33872051
8. McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. Dec 2021; 9(6): 100454. PMID 34731779
9. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Oct 2021; 206(4): 818-826. PMID 34384236
10. Sandhu JS, Bixler BR, Dahm P, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. Jan 2024; 211(1): 11-19. PMID 37706750
11. National Institute for Health and Care Excellence (2020). Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. https://www.nice.org.uk/guidance/mtg49/chapter/1-Recommendations. Accessed April 16, 2024.

Hydrogel Spacer

1. American Cancer Society. Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Updated January 19, 2024. Accessed May 22, 2024.
2. Gleason DF. Classification of prostatic carcinomas. Cancer Chemother Rep. Mar 1966; 50(3): 125-8. PMID 5948714
3. SEER Database. https://seer.cancer.gov/seerinquiry/index.php?page=view&id=20170036&type=q. Accessed May 22, 2024.
4. Forero DF, Almeida N, Dendukuri N. Hydrogel Spacer to reduce rectal toxicity in prostate cancer radiotherapy: a health technology assessment. Report No. 82. April 16, 2018. https://muhc.ca/sites/default/files/micro/m-TAU/SpaceOAR.pdf. Accessed May 22, 2024.
5. Skolarus TA, Dunn RL, Sanda MG, et al. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. Jan 2015; 85(1): 101-5. PMID 25530370
6. McDonald AM, Baker CB, Popple RA, et al. Different rectal toxicity tolerance with and without simultaneous conventionally-fractionated pelvic lymph node treatment in patients receiving hypofractionated prostate radiotherapy. Radiat Oncol. Jun 03 2014; 9: 129. PMID 24893842
7. Mariados N, Sylvester J, Shah D, et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. Aug 01 2015; 92(5): 971-977. PMID 26054865
8. Hamstra DA, Mariados N, Sylvester J, et al. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys. Apr 01 2017; 97(5): 976-985. PMID 28209443
9. Mariados NF, Orio PF, Schiffman Z, et al. Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. JAMA Oncol. Apr 01 2023; 9(4): 511-518. PMID 36757690
10. Fischer-Valuck BW, Chundury A, Gay H, et al. Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. Pract Radiat Oncol. 2017; 7(3): 195-202. PMID 28089528
11. Miller LE, Efstathiou JA, Bhattacharyya SK, et al. Association of the Placement of a Perirectal Hydrogel Spacer With the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. Jun 01 2020; 3(6): e208221. PMID 32585020
12. Babar M, Katz A, Ciatto M. Dosimetric and clinical outcomes of SpaceOAR in men undergoing external beam radiation therapy for localized prostate cancer: A systematic review. J Med Imaging Radiat Oncol. Jun 2021; 65(3): 384-397. PMID 33855816
13. Whalley D, Hruby G, Alfieri F, et al. SpaceOAR Hydrogel in Dose-escalated Prostate Cancer Radiotherapy: Rectal Dosimetry and Late Toxicity. Clin Oncol (R Coll Radiol). Oct 2016; 28(10): e148-54. PMID 27298241
14. Te Velde BL, Westhuyzen J, Awad N, et al. Can a peri-rectal hydrogel spaceOAR programme for prostate cancer intensity-modulated radiotherapy be successfully implemented in a regional setting?. J Med Imaging Radiat Oncol. Aug 2017; 61(4): 528-533. PMID 28151584
15. Pinkawa M, Piroth MD, Holy R, et al. Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. Strahlenther Onkol. Oct 2012; 188(10): 917-25. PMID 22933033
16. Pinkawa M, Berneking V, König L, et al. Hydrogel injection reduces rectal toxicity after radiotherapy for localized prostate cancer. Strahlenther Onkol. Jan 2017; 193(1): 22-28. PMID 27632342
17. Pinkawa M, Berneking V, Schlenter M, Krenkel B, Eble MJ. Quality of Life After Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: 5-Year Results. Int J Radiat Oncol Biol Phys. 2017; 99(2): 374-377.
18. Te Velde BL, Westhuyzen J, Awad N, et al. Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion. J Med Imaging Radiat Oncol. Dec 2019; 63(6): 836-841. PMID 31520465
19. Seymour ZA, Hamstra DA, Daignault-Newton S, et al. Long-term follow-up after radiotherapy for prostate cancer with and without rectal hydrogel spacer: a pooled prospective evaluation of bowel-associated quality of life. BJU Int. Sep 2020; 126(3): 367-372. PMID 32333714
20. Chao M, Ow D, Ho H, et al. Improving rectal dosimetry for patients with intermediate and high-risk prostate cancer undergoing combined high-dose-rate brachytherapy and external beam radiotherapy with hydrogel space. J Contemp Brachytherapy. Feb 2019; 11(1): 8-13. PMID 30911304
21. Kahn J, Dahman B, McLaughlin C, et al. Rectal spacing, prostate coverage, and periprocedural outcomes after hydrogel spacer injection during low-dose-rate brachytherapy implantation. Brachytherapy. 2020; 19(2): 228-233. PMID 32085930
22. Nehlsen AD, Sindhu KK, Moshier E, et al. The impact of a rectal hydrogel spacer on dosimetric and toxicity outcomes among patients undergoing combination therapy with external beam radiotherapy and low-dose-rate brachytherapy. Brachytherapy. 2021; 20(2): 296-301. PMID 33199175
23. Butler WM, Kurko BS, Scholl WJ, et al. Effect of the timing of hydrogel spacer placement on prostate and rectal dosimetry of low-dose-rate brachytherapy implants. J Contemp Brachytherapy. Apr 2021; 13(2): 145-151. PMID 33897787
24. American College of Radiology. ACR appropriateness criteria for external beam radiation therapy treatment planning for clinically localized prostate cancer. 2016. https://acsearch.acr.org/docs/69396/Narrative/. Accessed May 22, 2024.
25. Morgan SC, Hoffman K, Loblaw DA, et al. Hypofractionated Radiation Therapy for Localized Prostate Cancer: An ASTRO, ASCO, and AUA Evidence-Based Guideline. J Urol. Oct 09 2018. PMID 30316897
26. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer v4.2024. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed May 22, 2024.
27. National Institute for Health and Care Excellence. Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer. IPG752 2023. https://www.nice.org.uk/guidance/ipg752. Last Accessed May 22, 2024.

Policy History

• MA 4.043
• 9/30/2025 Partial adoption of commercial policy.