Rectal Spacer for Prostate Cancer

Overseen By Xin Liu, MD, Ph.D

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Extracapsular extension, Prior prostatectomy

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: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is evaluating whether a special gel called SpaceOAR Vue (an absorbable perirectal spacer) can guide radiation treatment for prostate cancer as effectively as the small markers currently used. The goal is to determine if this gel can simplify patient alignment during treatment. Individuals with prostate cancer confined to the prostate who have had or plan to have the gel and markers placed for radiation may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment precision for future patients.

Do I need to stop my current medications for this trial?

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 the SpaceOAR Vue rectal spacer is safe for use in radiotherapy alignment?

Research has shown that SpaceOAR Vue, a gel-like spacer, is generally safe for prostate cancer treatment. Studies have found that it can lower the risk of rectal damage during radiation therapy. Specifically, one study found that this spacer significantly reduces radiation harm to the rectum.

Additionally, reports indicate that SpaceOAR Vue helps maintain quality of life by reducing negative effects on urinary, sexual, and bowel functions. These findings suggest that patients generally tolerate the treatment well.

Overall, evidence supports SpaceOAR Vue as a safe option for those undergoing prostate cancer treatment. However, as with any medical treatment, discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SpaceOAR Vue for prostate cancer because it offers a novel approach to protecting healthy tissue during radiation therapy. Unlike traditional methods that may not provide precise spacing, SpaceOAR Vue is a hydrogel that creates a temporary space between the prostate and rectum, reducing radiation exposure to the rectum. This method is particularly appealing because it incorporates radio-opaque materials, enhancing visibility during imaging and ensuring accurate placement. By potentially minimizing side effects associated with radiation treatment, SpaceOAR Vue could improve the quality of life for patients undergoing prostate cancer therapy.

What evidence suggests that the SpaceOAR Vue rectal spacer is effective for prostate cancer radiotherapy alignment?

Research has shown that hydrogel spacers like SpaceOAR Vue, which participants in this trial will receive, can reduce side effects during radiation therapy for prostate cancer. Studies have found a 66% reduction in rectal damage with these spacers. SpaceOAR Vue creates a gap of about 1.1 cm between the prostate and rectum, protecting the rectum from radiation. Additionally, using SpaceOAR Vue is linked to a 60% decrease in serious urinary problems. This treatment is also easily visible on CT scans, aiding doctors in targeting the radiation more precisely. Overall, these spacers offer a promising way to reduce side effects during prostate cancer treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Joseph Miccio, MD

Principal Investigator

Penn State Caner Institute

Are You a Good Fit for This Trial?

This trial is for men with untreated prostate cancer stages cT1 to cT3. Participants must either already have the SpaceOAR and fiducial markers placed or plan to get them before starting radiotherapy.

Inclusion Criteria

I have had SpaceOAR and markers placed for prostate radiotherapy, or will have them placed.

My prostate cancer is in stages T1 to T3 and hasn't been treated.

Exclusion Criteria

My prostate cancer has spread outside the prostate gland.

I have had surgery to remove my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy with the use of SpaceOAR Vue® and fiducial markers for alignment

8 weeks

Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SpaceOAR Vue

Trial Overview The study tests if a radiopaque hydrogel rectal spacer, called SpaceOAR Vue®, can replace fiducial markers for patient alignment during prostate cancer radiotherapy treatments.

How Is the Trial Designed?

Group I: SpaceOAR Vue and fiducial marker Experimental Treatment 1 Intervention

After enrollment, patients will be treated per the standard of care, including the use of daily CBCT for image guided radiotherapy. The investigator will review the CBCT on the first day of treatment and align in such a way that the fiducials match up but also that the radio-opaque SpaceOAR lines up to within 5mm. If the SpaceOAR does not line up to within 5mm, the investigator will consider an intervention such as having the patient get off the table to pass gas, have a bowel movement, additional counseling about diet and bowel movement habits, or potentially even re-simulation. These daily CBCT images are aligned to the CT simulation images by way of aligning the fiducial markers on the respective imaging data sets. The CBCT images acquired during their first five fractions of radiotherapy will be imported into MIM software.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

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 case series of 13 prostate cancer patients treated with low-dose-rate brachytherapy, the use of SpaceOAR Vue™, a new iodinated hydrogel rectal spacer, improved the visibility of the rectal wall during treatment planning, which is crucial for minimizing rectal toxicity.

The study highlights that SpaceOAR Vue™ can enhance the accuracy of dosimetry in brachytherapy, potentially leading to safer and more effective treatment outcomes for patients at various risk levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Role of an Iodinated Rectal Hydrogel Spacer, SpaceOAR Vue™, in the Context of Low-Dose-Rate Prostate Brachytherapy, for Enhanced Post-Operative Contouring to Aid in Accurate Implant Evaluation and Dosimetry. Gross, A., Yuan, J., Spratt, D., 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 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]

The use of an absorbable hydrogel spacer during low-dose-rate brachytherapy for localized prostate cancer was successfully implemented in a 79-year-old patient without any acute complications during the procedure.

This case report highlights the first instance of ischemic proctitis occurring after the use of a hydrogel spacer in brachytherapy, which was resolved with conservative treatment after a 19-day hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic proctitis after low-dose-rate brachytherapy using hydrogel spacer for prostate cancer. Toriumi, R., Yaegashi, H., Sakurai, T., et al.[2022]

The study developed two deep-learning models for auto-contouring in patients with absorbable hydrogel spacers, showing that the model using a radiopaque spacer (Model II) significantly improved contouring accuracy compared to the model using a radio-transparent spacer (Model I).

Model II achieved substantial efficiency gains, with all regions of interest (ROIs) meeting clinical deployment criteria, indicating that the refined training methods enhanced the model's performance in accurately delineating critical areas during prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pair of deep learning auto-contouring models for prostate cancer patients injected with a radio-transparent versus radiopaque hydrogel spacer. Wang, Y., Boyd, G., Zieminski, S., 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001113

Analysis of The FDA Manufacturer and User Facility Device ... Clinical trials have shown that hydrogel spacers provide a low morbidity method for reducing rectal toxicity following radiation therapy in men ...

2. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/prostate-health/prostate-cancer/spaceoar-hydrogel/clinical-results/spaceoar-vue-hydrogel.html

SpaceOAR Vue Hydrogel Clinical Summary A meta-analysis including over 1000 patients across 7 hydrogel spacer trials demonstrated a mean perirectal separation of 1.1 cm and a 66% reduction in rectal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9680261/

Application of Hydrogel Spacer SpaceOAR Vue for ... The iodinated hydrogel is easily visualized on CT and helps delineate the rest of the prostate–rectum interface for better-targeted SBRT. 5.3.

4. spaceoar.com spaceoar.com/us/en/about-spaceoar-hydrogel/clinically-proven-results.html

SpaceOAR™ Hydrogel Clinical Trial | FDA Cleared The use of SpaceOAR Hydrogel reduced the likelihood of more serious changes in urinary quality of life by 60% compared to those in the control group.2. Bowel ...

5. internationalhealthcarereview.com internationalhealthcarereview.com/index.php/home/article/view/96

Efficacy and Applications of Hydrogel Spacers in Prostate ... Hydrogel spacers have shown to be a promising approach, with significant benefits in terms of symptom reduction and improvement in CT.

6. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/prostate-health/prostate-cancer/spaceoar-hydrogel/clinical-results.html

Clinical Data - SpaceOAR Hydrogel Learn how SpaceOAR™ Hydrogel temporarily creates space between the prostate and rectum, which may result in a significant reduction in rectal radiation ...

7. spaceoar.com spaceoar.com/us/en/home.html

SpaceOAR™ Hydrogel | Prostate Cancer Hydrogel Spacer In a clinical study, SpaceOAR™ Hydrogel was shown to help minimize the impact on urinary, sexual, and bowel quality of life for prostate cancer patients ...

8. academic.oup.com academic.oup.com/jscr/article/2023/3/rjad163/7091913

case of the missing spacer! | Journal of Surgical Case Reports The SpaceOAR Vue system has shown benefits such as a significant reduction in the rectal radiation dose and lower rates of rectal toxicity in ...