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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine if a radiopaque hydrogel rectal spacer, SpaceOAR Vue®, can be used in place of fiducial markers when aligning patients for radiotherapy. The investigator hypothesizes that the alignment of the patient based on the rectal spacer will be similar to the alignment of the patient with fiducial markers.

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 data supports the effectiveness of the treatment SpaceOAR Vue for prostate cancer?

Research shows that SpaceOAR Vue, a type of hydrogel spacer, helps reduce radiation exposure to the rectum during prostate cancer treatment, which can lower the risk of side effects. It is clearly visible on imaging, aiding in accurate treatment planning and evaluation. ^{1 2 3 4 5}

Is the rectal spacer for prostate cancer safe?

The rectal spacer, including versions like SpaceOAR Vue, has been studied in clinical trials and is generally considered safe, but some complications like rectal erosion and fistula formation have been reported. Most studies show it helps reduce radiation exposure to the rectum during prostate cancer treatment, with manageable side effects. ^{1 2 3 4 6}

How does the rectal spacer treatment for prostate cancer differ from other treatments?

The rectal spacer treatment for prostate cancer is unique because it involves injecting a hydrogel material between the prostate and rectum to physically separate them, reducing radiation exposure to the rectum during therapy. This approach helps minimize side effects compared to traditional radiation treatments that do not use spacers. ^{1 3 7 8 9}

Research Team

Joseph Miccio, MD

Principal Investigator

Penn State Caner Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. United States 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. [2023]

3. United States 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The case of the missing spacer! [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Polyethylene glycol-based gels for treatment of prostate cancer: pictorial review of normal placement and complications. [2023]

8. Australia pubmed.ncbi.nlm.nih.gov

Ischemic proctitis after low-dose-rate brachytherapy using hydrogel spacer for prostate cancer. [2022]

9. United States 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. [2023]