Rectal Spacers for Prostate Cancer

Overseen By Shawn Zimberg, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Advanced Radiation Centers of New York

Must not be taking: Steroids

Disqualifiers: Metastatic disease, Prostatectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a special balloon-like device designed to protect healthy tissue during radiation therapy for prostate cancer. The spacer, known as the BioProtect Balloon Implant™ System, is placed near the prostate to create a barrier, reducing potential damage to the rectum during treatment. Men with localized prostate cancer, scheduled for radiation therapy and meeting specific cancer characteristics, are suitable candidates for this study. Participants will attend several check-ins, including after receiving the spacer and during follow-up visits. As an unphased trial, this study allows participants to contribute to innovative research that could enhance radiation therapy safety for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have active inflammatory bowel disease requiring treatment with steroids, you may not be eligible to participate.

What prior data suggests that the BioProtect Balloon Implant System is safe for use in patients undergoing radiation therapy for prostate cancer?

Research has shown that the BioProtect Balloon Implant System is a safe option for treating prostate cancer. In one study, no patients experienced serious side effects. Only 6% reported mild sexual side effects, and 19% had moderate side effects over five years. These findings suggest that the treatment is generally well-tolerated. The balloon is biodegradable, breaking down and being absorbed by the body within six months. Additionally, FDA approval indicates its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BioProtect Balloon Implant System is unique because it uses a biodegradable balloon to create a physical space between the prostate and the rectum during prostate cancer radiation therapy. This is different from traditional methods that often involve permanent implants or no spacer at all, potentially resulting in more radiation exposure to the rectum. The biodegradable nature of the balloon means it naturally dissolves over time, reducing long-term side effects. Researchers are excited about this treatment because it promises to improve radiation targeting and patient comfort while minimizing damage to surrounding healthy tissues.

What evidence suggests that the BioProtect Balloon Implant System is effective for prostate cancer?

Research has shown that the BioProtect Balloon Implant System, which trial participants will receive, effectively reduces radiation exposure to the rectum during prostate cancer treatment. In one study, 97.9% of patients with the balloon experienced a significant drop in radiation to the rectum, protecting this sensitive area. This reduction is crucial as it can decrease side effects and discomfort for patients. Additionally, long-term studies indicate that using the balloon spacer helps maintain a good quality of life during and after treatment. Overall, the BioProtect Balloon Implant System has shown promising results in making prostate cancer radiation therapy safer and more comfortable. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for up to 150 people with localized prostate cancer who are planning to have radiation therapy. Participants must be eligible for rectal spacer placement, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent form

My prostate cancer is in the early stages and not aggressive.

I am scheduled for radiation therapy with a rectal spacer.

Exclusion Criteria

My cancer has spread to other parts of my body.

I am being treated with steroids for my inflammatory bowel disease.

I have inflammation of the prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Spacer Placement

Participants undergo placement of the rectal spacer prior to radiation therapy

Treatment Planning Simulation

Participants undergo treatment planning simulation to prepare for radiation therapy

Radiation Treatment

Participants receive radiation therapy for the treatment of localized prostate cancer

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1, 3, and 6-month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• BioProtect Balloon Implant™ System

Trial Overview

The study is testing the BioProtect Balloon Implant™ System as a rectal spacer in patients receiving radiation treatment for prostate cancer. It aims to evaluate its safety and effectiveness through several visits including screening, implantation, simulation, post-treatment, and follow-ups at 1, 3, and 6 months.

How Is the Trial Designed?

Group I: BioProtect Balloon Implant System Experimental Treatment 1 Intervention

The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

Who Is Running the Clinical Trial?

Advanced Radiation Centers of New York

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

In a study of 160 patients, the hydrogel spacer was successfully placed with a symmetrical distribution in 73.1% of cases, effectively separating the prostate from the rectum by an average of 10.2 mm, which helps reduce radiation exposure to the rectum during therapy.

The procedure had a low incidence of complications, with only 4.3% of patients experiencing minimal rectal wall infiltration and a very small number requiring emergency treatment, indicating that the hydrogel spacer can be safely used in patients undergoing radiation for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer. Yates, AH., Power, JW., Dempsey, PJ., et al.[2023]

The use of a hydrogel spacer during prostate cancer radiotherapy showed no significant increase in bowel bother symptoms compared to conventional treatment methods, indicating its safety in preserving bowel quality of life during treatment.

While all groups experienced moderate changes in bowel quality of life during radiotherapy, the hydrogel spacer group showed the least long-term impact on bowel bother scores, suggesting potential benefits in symptom management a few weeks post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. Pinkawa, M., Piroth, MD., Holy, R., et al.[2021]

The SpaceOAR® hydrogel system, designed to protect the rectum during prostate radiotherapy, can potentially cause rectal toxicity, as evidenced by a case where a 75-year-old man developed a rectal ulcer after its insertion.

Post-implant magnetic resonance imaging (MRI) was effective in detecting hydrogel infiltration into the rectum, suggesting that MRI could be a valuable follow-up tool to monitor for complications related to SpaceOAR® hydrogel use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. Imai, K., Sakamoto, H., Akahane, M., et al.[2022]

A case was reported of a severe rectal ulcer classified as a grade 3 complication following intensity-modulated radiotherapy for prostate cancer, indicating a significant adverse effect of the treatment.

The complication occurred despite the use of the SpaceOAR® hydrogel spacer, which is designed to reduce radiation exposure to the rectum during prostate cancer treatment, highlighting the need for careful monitoring of side effects even with protective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Rectal Ulcer during Intensity Modulated Radiotherapy for Prostate Cancer Using Hydrogel Spacer. Dinh, TT., Schade, GR., Liao, JJ.[2023]

Hydrogel rectal spacers are beneficial in reducing radiation exposure to the rectum during external beam radiation therapy for prostate cancer, which can help minimize adverse effects.

The review provides a comprehensive framework for the effective use of rectal spacers in patients with unfavorable risk prostate cancer undergoing dose escalated Stereotactic Body Radiation Therapy (SBRT), highlighting best practices and treatment planning considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for Utilization of Hydrogel Rectal Spacers in Dose Escalated SBRT for the Treatment of Unfavorable Risk Prostate Cancer. Repka, MC., Creswell, M., Lischalk, JW., et al.[2022]

In a study of 149 patients, hydrogel spacers were effective in significantly reducing rectal radiation dose during prostate cancer treatment, even when the spacers were asymmetrically placed, with 98.7% of patients achieving significant dose reduction.

Rectal wall infiltration of the hydrogel spacer occurred in only 6% of patients, and this infiltration did not correlate with any adverse events or complications, indicating a favorable safety profile for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Fischer-Valuck, BW., Chundury, A., Gay, H., et al.[2018]

The absorbable hydrogel perirectal spacer (SpaceOAR®) was successfully implanted in 222 men undergoing prostate cancer radiotherapy, with a 99.3% success rate and minimal mild transient side effects, indicating it is a safe and tolerable procedure.

The spacer significantly reduced the rectal radiation dose in 97.3% of patients and led to lower rates of late rectal toxicity and improved bowel quality of life compared to the control group, suggesting it enhances the safety and efficacy of prostate radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel Spacer Application Technique, Patient Tolerance and Impact on Prostate Intensity Modulated Radiation Therapy: Results from a Prospective, Multicenter, Pivotal Randomized Controlled Trial. Pieczonka, CM., Mariados, N., Sylvester, JE., et al.[2023]

The SpaceOAR hydrogel spacer is a safe and well-tolerated procedure with a 99% technical success rate, effectively creating over 1 cm of space between the prostate and rectum, which significantly reduces rectal radiation exposure during prostate cancer treatment.

Patients receiving the hydrogel spacer experienced lower rates of acute and long-term rectal toxicity, as well as improved bowel, urinary, and sexual quality of life, with notable improvements in sexual function observed at 37 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data. Karsh, LI., Gross, ET., Pieczonka, CM., et al.[2018]

Citations

1.

redjournal.org

redjournal.org/article/S0360-3016(24)02959-6/abstract

Prospective, Randomized Controlled Pivotal Trial of ...

Biodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10747072/

Assessment of Bioprotect's Biodegradable Balloon System as ...

This study comprehensively assessed tissue responses following the implantation of the Bioprotect biodegradable fillable balloon as a rectal ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301624029596

Prospective, Randomized Controlled Pivotal Trial of ...

The primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (P < .001). Mean V70 was 7.0 % pre- versus 1.1% ...

4.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12692-x

Long-term evaluation of the safety of a rectal-prostate spacer ...

The aim was to evaluate the long-term outcomes and safety of the BioProtect balloon spacer in patients treated with radiotherapy for low- or ...

5.

morningstar.com

morningstar.com/news/pr-newswire/20251107ln17741/long-term-study-reports-sustained-quality-of-life-benefits-with-the-bioprotect-balloon-spacer-in-prostate-cancer-radiation-therapy

Long-Term Study Reports Sustained Quality of Life ...

Long-Term Study Reports Sustained Quality of Life Benefits with the BioProtect Balloon Spacer in Prostate Cancer Radiation Therapy. Provided ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11292989/

Long-term evaluation of the safety of a rectal-prostate ...

No toxicity of grade 2 or higher was found. Cumulative sexual toxicity at 5 years was grade 1 in 6% (1/16 patients) and grade 2 in 19% of ...

7.

prnewswire.com

prnewswire.com/il/news-releases/long-term-study-reports-sustained-quality-of-life-benefits-with-the-bioprotect-balloon-spacer-in-prostate-cancer-radiation-therapy-302607671.html

Long-Term Study Reports Sustained Quality of Life ...

The spacer provides visible, controllable separation and is resorbed within six months.³ Cleared by the U.S. FDA in 2023, the BioProtect Balloon ...

8.

grandroundsinurology.com

grandroundsinurology.com/industry-perspective-bioprotect-balloon-implant-system/

Industry Perspective: BioProtect Balloon Implant™ System

Daniel Y. Song, MD, compares the BioProtect Balloon Implant™ System to current rectal spacers in this presentation, sponsored by BioProtect.