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

Trial Summary

What is the purpose of this trial?

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.

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 data supports the effectiveness of the treatment Rectal Spacers for Prostate Cancer?

Research shows that using hydrogel spacers, like the SpaceOAR system, can significantly reduce the amount of radiation the rectum receives during prostate cancer treatment, which may help lower the risk of side effects. Studies indicate that these spacers can create extra space between the prostate and rectum, reducing radiation exposure to the rectum by 43% to 84%. ^{1 2 3 4 5}

Is the use of rectal spacers for prostate cancer safe?

Rectal spacers, like the SpaceOAR system, are generally considered safe but can have complications such as rectal perforation, infection, and other severe issues like rectal erosion and fistula formation. While they help reduce radiation exposure to the rectum during prostate cancer treatment, it's important to weigh these benefits against the potential risks. ^{2 3 6 7 8}

How do rectal spacers differ from other treatments for prostate cancer?

Rectal spacers, like hydrogel spacers, are unique because they create a physical space between the prostate and rectum during radiation therapy, reducing radiation exposure to the rectum and minimizing side effects. This approach is different from other treatments as it focuses on protecting surrounding tissues rather than directly targeting the cancer itself. ^{2 3 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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 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]

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]

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]

References

1. 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]

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Rectal Perforation by a Balloon Spacer: A Rare Cause of Rectal Perforation Addressed Endoscopically. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

[Prostate-rectum spacers: optimization of prostate cancer irradiation]. [2018]

6. United States 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The case of the missing spacer! [2023]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer. [2023]

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

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