Does biodegradable peri-rectal spacer mitigate treatment toxicities in radiation therapy for localised prostate cancer—a systematic review and meta-analysis | Prostate Cancer and Prostatic Diseases

Biodegradable Spacers: A Game-Changer in Reducing Radiation Side Effects for Prostate Cancer Patients

For men undergoing radiation therapy for prostate cancer, one of the most significant concerns has been potential damage to the rectum, which sits directly adjacent to the prostate. Recent advances in biodegradable spacer technology are showing remarkable promise in protecting patients from these unwanted side effects, with compelling evidence now available from multiple clinical trials.

New Meta-Analysis Confirms Benefits

A comprehensive 2025 systematic review and meta-analysis published in Prostate Cancer and Prostatic Diseases has provided definitive evidence supporting the use of biodegradable peri-rectal spacers. The study, led by researchers including Chris Ho-Ming Wong and colleagues, analyzed data from 17 studies involving over 3,200 patients.

The results were striking: patients with spacers experienced significantly lower rates of late rectal toxicity (1.62% vs. 9.35%) and early grade 2 or above rectal toxicity (3.07% vs. 6.05%) compared to those without spacers. Importantly, the study found no negative impacts on urinary or sexual quality of life domains.

How Spacer Technology Works

Biodegradable spacers create a physical separation between the prostate and rectum during radiation therapy. These devices typically fall into two main categories:

  1. Hydrogel Spacers: These spacers use a hydrogel compound injected under ultrasound guidance, typically during fiducial marker insertion or as a standalone procedure before radiotherapy. After treatment, the body naturally reabsorbs the hydrogel material.
  2. Balloon Spacers: A newer innovation, these devices create a controlled, reproducible space between the rectum and prostate. Recent clinical trial data published in 2024 showed a biodegradable balloon spacer effectively reduced rectal radiation dose and demonstrated consistent resorption within 6 months after treatment.

Advancing Technologies

The field continues to evolve with promising new approaches. As Johns Hopkins radiation oncologist Dr. Daniel Song notes, "We evaluated the efficacy and safety of a novel spacer balloon that goes between the prostate and rectum, which allows the potential for controlled, adaptable deployment."

One such technology, the BioProtect Rectal Balloon Spacer, has been shown to be effective in clinical studies for protecting healthy rectal tissues during radiation therapy. This cutting-edge device creates a protective space between the prostate and rectum, significantly reducing radiation exposure to critical areas.

Clinical Implications

For patients considering radiation therapy for prostate cancer, these advances represent a significant quality-of-life improvement. Multiple Phase II and III clinical trials and subsequent meta-analyses have corroborated that hydrogel spacers are associated with reduced rectal morbidity.

The National Institute for Health and Care Excellence (NICE) guidelines now support the use of biodegradable spacer devices in both external beam radiotherapy and brachytherapy for prostate cancer.

Looking Forward

Research continues to explore additional benefits of spacer technology, including applications in stereotactic body radiotherapy and hypofractionated treatment regimens. Future research questions include the role of spacers in prostate stereotactic beam radiotherapy and post-radiotherapy local recurrence prevention.

Patient Considerations

If you're facing radiation therapy for prostate cancer, discussing spacer options with your radiation oncologist is highly recommended. The evidence now clearly indicates these devices can significantly reduce treatment-related side effects while maintaining treatment efficacy.

References

  1. Wong CH, Ko IC, Leung DK, et al. Does biodegradable peri-rectal spacer mitigate treatment toxicities in radiation therapy for localised prostate cancer—a systematic review and meta-analysis. Prostate Cancer and Prostatic Diseases. 2025. https://www.nature.com/articles/s41391-025-00961-0
  2. Harvey N, Perera M. Comprehensive review of the use of hydrogel spacers prior to radiation therapy for prostate cancer. BJU International. 2023. https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15821
  3. Karsh LI. SpaceOAR Hydrogel - Prostate-Rectum Spacing in Radiation Therapy. Grand Rounds in Urology. 2018. https://grandroundsinurology.com/spaceoar-hydrogel/
  4. Song D, Dabkowski M, Costa P, et al. Prospective, Randomized Controlled Pivotal Trial of Biodegradable Balloon Rectal Spacer for Prostate Radiation Therapy. International Journal of Radiation Oncology, Biology, Physics. 2024. https://www.redjournal.org/article/S0360-3016(24)02959-6/abstract
  5. Comprehensive review of hydrogel spacers prior to radiation therapy for prostate cancer. 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9734283/
  6. Johns Hopkins Medicine. Protecting the Rectum During Prostate Radiation Therapy: A Spacer Balloon. 2024. https://www.hopkinsmedicine.org/news/articles/2024/12/protecting-the-rectum-during-prostate-radiation-therapy-a-spacer-balloon
  7. Advanced Radiation Centers of New York. BioProtect Rectal Balloon Spacer. 2024. https://www.advancedradiationcenters.com/technologies/bioprotect-rectal-balloon-spacer/
  8. Kang J. Endorectal Balloon and Radiation therapy and Rectal Spacer in Prostate Cancer. Clinical Trials Registry. 2019. https://ichgcp.net/clinical-trials-registry/NCT02911922

Does biodegradable peri-rectal spacer mitigate treatment toxicities in radiation therapy for localised prostate cancer—a systematic review and meta-analysis | Prostate Cancer and Prostatic Diseases

Prostate Cancer and Prostatic Diseases (2025)Cite this article

Abstract

Introduction

There is an increasing use of biodegradable peri-rectal spacer prior to radiation therapy for prostate cancer to reduce treatment-associated rectal toxicity. While data from individual trials and cohorts is maturing, there is a lack of an updated quantitative analysis that includes outcomes following peri-rectal spacer. We aim to delineate the clinical impact of peri-rectal spacer in localised prostate cancer patients treated with radiotherapy.

Methods

In March 2024, a systematic search was performed on MEDLINE, Embase, and Cochrane Central Register of controlled trials for publications since the year 2010. Prospective and retrospective studies reporting comparative outcomes of patients with and without peri-rectal spacer prior to radiotherapy were considered. Outcomes are reported in binary fashion. Random effect meta-analysis with the use of weighted mean difference was adopted. Early (≤3 months) and late rectal toxicity stratified according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria, early and late genitourinary toxicity, quality of life in bowel, sexual and urinary domains (in terms of minimal clinically important difference) were assessed.

Results

The systematic review included 17 studies. There are 3 RCTs, 3 prospective cohorts, and 11 retrospective cohorts. Three thousand two hundred patients were included, with 1471 patients who received peri-rectal spacer and 1729 without. The use of spacer is associated with lower likelihood of late (1.62% vs. 9.35%, RR = 0.25, 95% CI = 0.15–0.42, P < 0.001) and early grade 2 or above late rectal toxicity (3.07% vs. 6.05%, RR = 0.53, 95% CI = 0.33–0.86, P < 0.001). No difference is observed in significant grade 3 or above GI (acute or late) events. There is no statistical difference in bowel-related bowel QoL (risk difference = −0.16, 95% CI = −0.38–0.06, P = 0.15). The perirectal spacer is not associated with negative impact to urinary or sexual domains of QoL either.

Conclusion

In localised prostate cancer patients treated with radiation therapy, the use of peri-rectal spacer is associated with reduced rectal toxicities.

 

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