Policy title: Hydrogel Spacer Use During Radiotherapy for Prostate Cancer

Policy number: MA 4.054

Effective date: 10/1/2026

Policy

Hydrogel Rectal Spacer use during radiotherapy for prostate cancer is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Use of hydrogel spacer for any other indication 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 4.043 Focal Treatments for Prostate Cancer
• MP 4.053 Transurethral Water Vapor Thermal Therapy for Benign Prostatic Hypertrophy
• MA 5.053 Magnetic Resonance-Guided Focused Ultrasound

Description/Background

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 crosswalk 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

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

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 for Hydrogel Therapy

References

1. American Cancer Society. Key Statistics for Prostate Cancer. Key Statistics for Prostate Cancer. Updated January 16, 2025. Accessed May 21, 2025.
2. Gleason DF. Classification of prostatic carcinomas. Cancer Chemother Rep. Mar 1966; 50(3): 125-8. PMID 5948714
3. SEER Database. SEER Inquiry Database. Accessed May 21, 2025.
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. Hydrogel Spacer Health Technology Assessment. Accessed May 21, 2025.
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. ACR Appropriateness Criteria. Accessed May 21, 2025.
25. American Urological Association. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline (2022). Clinically Localized Prostate Cancer Guideline. Accessed May 21, 2025.
26. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer v2.2025. NCCN Prostate Cancer Guidelines. Accessed May 21, 2025.
27. National Institute for Health and Care Excellence. Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer. IPG752. 2023. NICE IPG752 Guidance. Last accessed May 21, 2025.

Policy History

• MA 4.054
• 04/01/2026 Major review; Creation of new policy. Statement removed from MA 4.043.

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.