Rectal Spacers for Prostate Cancer

Overseen By Edward Soffen, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Princeton ProCure management, LLC.

Must not be taking: Steroids

Disqualifiers: Metastatic disease, Prior prostate therapy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2-4 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, known as rectal spacers, for men with prostate cancer undergoing Proton Beam Therapy (PBT). The goal is to determine if these spacers, SpaceOAR Vue and BioProtect Balloon Implant System, can protect nearby organs during treatment. Men diagnosed with localized prostate cancer, with a Gleason Score of 7 or below, and scheduled for PBT may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve treatment safety for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these rectal spacers are safe for prostate cancer patients?

Previous studies have shown that the SpaceOAR Vue hydrogel is safe for patients with prostate cancer undergoing radiation therapy. It reduces the radiation reaching the rectum, lowering the risk of side effects. The hydrogel is generally well-tolerated, with low rates of issues related to urination, sexual health, and bowel movements.

Research on the BioProtect Balloon Implant System also indicates safety. Most patients (98%) experienced a significant reduction in radiation reaching the rectum, preventing damage. Long-term data shows very few serious side effects, with only mild sexual side effects in a small number of patients.

Both treatments aim to enhance the safety of radiation therapy by protecting the rectum, reducing discomfort and long-term side effects during prostate cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for prostate cancer because they both offer innovative ways to protect healthy tissue during radiation therapy. The BioProtect Balloon Implant System and SpaceOAR Vue are rectal spacers designed to physically separate the prostate from the rectum. This separation minimizes radiation exposure to the rectum, potentially reducing side effects compared to traditional treatments, which don't provide this level of protection. Unlike standard options that rely solely on precision targeting, these spacers add a physical barrier, offering an extra layer of safety during treatment. This new approach could lead to improved outcomes and a better quality of life for patients.

What evidence suggests that these rectal spacers are effective for prostate cancer?

Research has shown that the SpaceOAR Vue hydrogel spacer, one of the treatments in this trial, helps reduce damage to the rectum in prostate cancer patients receiving radiation therapy. A study of over 1,000 patients found that this spacer creates a significant gap between the rectum and prostate, reducing rectal side effects by 66%. It also lowers the risk of serious urinary problems by 60% compared to patients who do not use the spacer.

The BioProtect Balloon Implant System, another treatment option in this trial, has significantly reduced the amount of radiation reaching the rectum in studies. In one trial, 98% of patients experienced more than a 25% decrease in rectal radiation exposure. This reduction is associated with a better long-term quality of life for patients. Both treatments in this trial show promise in reducing the side effects of radiation therapy for prostate cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for up to 50 people with localized prostate cancer who are planning to undergo Proton Beam Therapy. Participants will be monitored from spacer placement through treatment and up to a 6-month follow-up.

Inclusion Criteria

PSA less than or equal to 20 ng/mL

My prostate cancer has a Gleason Score of 7 or less.

I understand and am ready to sign the consent form.

Exclusion Criteria

I currently have a urinary tract infection.

I am scheduled for radiotherapy targeting the lymph nodes in my pelvis.

I have inflammation or infection in my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Spacer Placement

Participants undergo spacer placement to prepare for Proton Beam Therapy

1 week

1 visit (in-person)

Treatment Planning

Treatment planning for Proton Beam Therapy is conducted

1 week

1 visit (in-person)

Treatment

Participants receive Proton Beam Therapy

2-4 months

End-of-Treatment Assessment

Assessment conducted at the end of the treatment phase

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• BioProtect Balloon Implant System
• SpaceOAR Vue

Trial Overview The study is testing two types of rectal spacers: BioProtect Balloon Implant System and SpaceOAR Vue, in patients receiving PBT, comparing their effectiveness and outcomes during the course of treatment.

How Is the Trial Designed?

Group I: SpaceOAR Vue Experimental Treatment 1 Intervention

Group II: BioProtect Balloon Implant System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Princeton ProCure management, LLC.

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

The use of biodegradable spacers, like the BioProtect® balloon, is intended to improve radiation therapy for prostate cancer by protecting the rectum from high doses of radiation, but they carry risks of complications.

In a case study of a 59-year-old man, a rectal perforation occurred one month after spacer injection, highlighting the potential risks associated with this treatment despite its intended benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rectal Perforation by a Balloon Spacer: A Rare Cause of Rectal Perforation Addressed Endoscopically. Barros, S., Roseira, J., Caldeira, P., et al.[2022]

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 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]

Rectal spacers, specifically polyethylene glycol-based gels like SpaceOAR and Space-OAR Vue, are essential in prostate cancer radiotherapy as they help protect the rectum from radiation damage.

Radiologists need to be aware of both the correct and incorrect placements of these spacers, as improper placement can lead to ineffective treatment and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene glycol-based gels for treatment of prostate cancer: pictorial review of normal placement and complications. Mathur, M., Asch, D., Israel, G.[2023]

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 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]

SpaceOAR® hydrogel injection, approved by the FDA, effectively reduces rectal radiation exposure during prostate radiotherapy, leading to lower rates of rectal toxicity, but remains in early clinical use with emerging safety concerns.

A review of safety reports revealed serious complications associated with SpaceOAR, including acute pulmonary embolism and rectal wall erosion, indicating a need for ongoing monitoring and further research as its use becomes more widespread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major Complications and Adverse Events Related to the Injection of the SpaceOAR Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience Database. Aminsharifi, A., Kotamarti, S., Silver, D., et al.[2020]

The use of biodegradable spacers injected between the prostate and rectum during radiotherapy can significantly reduce the amount of radiation the rectum receives, with reductions of 43% to 84% in the volume exposed to at least 70 Gy, enhancing treatment safety.

Preliminary clinical results indicate that these spacers are well-tolerated by patients and may lead to fewer acute side effects, suggesting they could improve the overall experience of radiotherapy for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate-rectum spacers: optimization of prostate cancer irradiation]. Zilli, T., Benz, E., Miralbell, R.[2018]

The SpaceOAR Vue hydrogel system is designed to protect the rectum from radiation damage during prostate cancer treatment and has been reported as effective and safe in initial trials.

However, complications such as rectal erosion, abscess, and fistula formation have been observed, raising concerns about its safety as its use becomes more routine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case of the missing spacer! Boerkamp, A., De Robles, MS.[2023]

Citations

1. urotoday.com urotoday.com/conference-highlights/astro-2025/astro-2025-prostate-cancer/163504-astro-2025-long-term-toxicity-and-patient-reported-quality-of-life-after-prostate-imrt-with-or-without-biodegradable-balloon-rectal-spacer-analysis-of-a-pivotal-randomized-trial.html

ASTRO 2025: Long-Term Toxicity and Patient-Reported ... Overall, 98% of patients achieved a ≥25% reduction in rV70. On safety, 18% of patients in the balloon group and 23.1% in the control group ...

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

Long-term evaluation of the safety of a rectal-prostate ... The use of a rectal-prostate spacer of the ProSpace® balloon type seems to be well accepted by patients with intermediate- or low-risk prostate cancer.

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. 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 ...

5. 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 ...

6. 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 ... Four-year follow-up demonstrates preserved bowel, urinary, and sexual outcomes with consistent, reproducible spacing. BETHLEHEM, Pa., Nov.