Rectal Spacers for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Advanced Radiation Centers of New York

Must not be taking: Steroids

Disqualifiers: Metastatic disease, Prostatectomy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits: * Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1,3,and 6-months FU visits.

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 data supports the idea that Rectal Spacers for Prostate Cancer is an effective treatment?

The available research shows that rectal spacers, like the hydrogel spacer, are effective in reducing the radiation dose to the rectum during prostate cancer treatment. This helps in minimizing the side effects and damage to the rectal area. Studies indicate that these spacers create a physical barrier between the prostate and rectum, which lowers the risk of rectal damage compared to treatments without spacers. This makes the treatment safer and more tolerable for patients. ^{1 2 3 4 5}

What safety data is available for rectal spacers in prostate cancer treatment?

The safety data for rectal spacers, such as the SpaceOAR system, includes findings from phase 2 and 3 clinical trials. These studies have evaluated the safety of the application technique, implant quality, and the resulting reduction in rectal dose. They have also assessed acute and long-term rectal, urinary, and sexual toxicity, as well as patient-reported outcomes. While the hydrogel spacer is generally effective in reducing rectal dose during radiotherapy, there are reports of complications such as rectal ulcers, which can be severe in some cases. Overall, the safety profile is supported by prospective randomized controlled trials, but potential risks like rectal wall infiltration and associated toxicity should be considered. ^{2 3 5 6 7}

Is the treatment called Rectal Spacers for Prostate Cancer a promising treatment?

Yes, rectal spacers are a promising treatment for prostate cancer. They help protect the rectum by creating a space between it and the prostate during radiation therapy. This reduces the amount of radiation the rectum receives, which can lower the risk of side effects and improve the patient's quality of life. ^{1 2 3 4 8}

Eligibility Criteria

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 18 or older with prostate cancer.

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.

Trial Timeline

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

Treatment Details

Interventions

• BioProtect Balloon Implant™ System (Brachytherapy)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Advanced Radiation Centers of New York New Hyde Park, NY

Who Is Running the Clinical Trial?

Advanced Radiation Centers of New York Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. [2021] Hydrogel spacer is an innovative method to protect the rectal wall during prostate cancer radiotherapy. Clinical effects are not well known.

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] Hydrogel prostate-rectum spacers, biomaterials placed between the prostate and rectum, continue to gain interest as a method to reduce or limit rectal dose during dose escalated prostate cancer radiation therapy. Because the spacer is initially injected into the perirectal space as a liquid, the final distribution can vary. The purpose of this study was to evaluate hydrogel spacer (SpaceOAR system) implantation and distribution from a recent prospective randomized control trial and correlate spacer symmetry with rectal dose reduction as well as rectal wall infiltration (RWI) to acute and late toxicity.

3. 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] We evaluate the safety, tolerability and impact on therapy of an absorbable hydrogel perirectal spacer (SpaceOAR® system) designed to reduce the rectal radiation dose during prostate cancer radiotherapy.

4. England pubmed.ncbi.nlm.nih.gov

SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer. [2023] Hydrogel spacers aim to separate the rectum from the prostate during radiation therapy for patients with prostate cancer to decrease the radiation dose and thus toxicity to the rectum. The aim of this study was to evaluate the distribution of the hydrogel spacer between the rectum and the prostate, to assess for hydrogel rectal wall infiltration and to assess for immediate complications.

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

Spontaneous remission of rectal ulcer associated with SpaceOAR® hydrogel insertion in radiotherapy for prostate cancer. [2022] Label="INTRODUCTION" NlmCategory="BACKGROUND">The SpaceOAR® hydrogel system separates the prostate and rectum to reduce rectal irradiation during prostate radiotherapy. However, it could induce rectal toxicity.

6. 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] To provide an update on SpaceOAR System, a Food and Drug Administration-approved hydrogel indicated to create distance between the prostate and the rectum which has been studied in phase 2 and 3 clinical trials. Here, we review and summarize these clinical results including the safety of prostate-rectum spacer application technique, the implant quality and resulting rectal dose reduction, acute and long-term rectal, urinary, and sexual toxicity, as well as patient-reported outcomes.

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

A Case of Rectal Ulcer during Intensity Modulated Radiotherapy for Prostate Cancer Using Hydrogel Spacer. [2023] We report a case of a severely symptomatic rectal ulcer, a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 complication, after intensity modulated radiotherapy for prostate cancer using the SpaceOAR® hydrogel spacer.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Rationale for Utilization of Hydrogel Rectal Spacers in Dose Escalated SBRT for the Treatment of Unfavorable Risk Prostate Cancer. [2022] In this review we outline the current evidence for the use of hydrogel rectal spacers in the treatment paradigm for prostate cancer with external beam radiation therapy. We review their development, summarize clinical evidence, risk of adverse events, best practices for placement, treatment planning considerations and finally we outline a framework and rationale for the utilization of rectal spacers when treating unfavorable risk prostate cancer with dose escalated Stereotactic Body Radiation Therapy (SBRT).