Rectal Spacer for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byJoseph Miccio, MD
Age: Any Age
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Extracapsular extension, Prior prostatectomy
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12346How 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.
13789Eligibility 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.
Trial 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
Participant Groups
The study tests if a radiopaque hydrogel rectal spacer, called SpaceOAR Vue®, can replace fiducial markers for patient alignment during prostate cancer radiotherapy treatments.
1Treatment groups
Experimental Treatment
Group I: SpaceOAR Vue and fiducial markerExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Cancer InstituteHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
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]We present a case series of 13 consecutive patients with prostate cancer treated with low-dose-rate (LDR) brachytherapy, utilizing SpaceOAR Vue™, the recent iodinated iteration of the SpaceOAR™ hydrogel rectal spacer. Low- and favorable intermediate-risk patients receiving monotherapy and unfavorable intermediate- and high-risk patients undergoing a brachytherapy boost were included. Permanent brachytherapy can result in subacute and late rectal toxicity, and precise contouring of the anterior rectal wall and posterior aspect of the prostate is essential for accurate dosimetry to confirm a safe implant. Clearly visible on non-contrast CT imaging, SpaceOAR Vue™ can substantially aid in post-implant contouring and analysis. Not previously described in the literature in the context of LDR brachytherapy, we demonstrate the added clinical benefit of placing a well-visualized rectal spacer.
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.
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.
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.
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.
The case of the missing spacer! [2023]The SpaceOAR Vue hydrogel system was developed to reduce the toxicity to the rectum following radiation therapy for prostate cancer. Initial trial data reported the product as overall effective and safe. However, a few additional observed complications have likely been brought on by its increased utilization. The case presented herein describes rectal erosion, with abscess and rectal fistula formation, associated with the use of the SpaceOAR Vue hydrogel system. The SpaceOAR Vue hydrogel system was subsequently found to be absent between radiotherapy treatments and was thought to have been passed rectally through the fistula. The benefits and complications of the SpaceOAR Vue hydrogel system are discussed, as well as key factors to consider as the recommendation of routine use increases.
Polyethylene glycol-based gels for treatment of prostate cancer: pictorial review of normal placement and complications. [2023]Rectal spacers are commonly used in the radiotherapy for prostate cancers, serving as a means to protect the rectum and surrounding structures from radiation toxicity. Polyethylene Glycol-Based Gels (SpaceOAR ™ and Space-OAR Vue™, Boston Scientific) are the most commonly used rectal spacers. Given their increasingly widespread use and the relative paucity of radiology literature on this topic, it is imperative for the radiologist to recognize both the normal and abnormal placement of these polyethylene glycol-based rectal spacers, particularly as the latter may be associated with suboptimal therapy and/or complications.
Ischemic proctitis after low-dose-rate brachytherapy using hydrogel spacer for prostate cancer. [2022]Recently, an absorbable hydrogel spacer is becoming more widespread to reduce rectal radiation dose for radiation therapy for localized prostate cancer.
A pair of deep learning auto-contouring models for prostate cancer patients injected with a radio-transparent versus radiopaque hydrogel spacer. [2023]Absorbable hydrogel spacer injected between prostate and rectum is gaining popularity for rectal sparing. The spacer alters patient anatomy and thus requires new auto-contouring models.