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: Princeton ProCure management, LLC.
Must not be taking: Steroids
Disqualifiers: Metastatic disease, Prior prostate therapy, others
No Placebo Group
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%.12345
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.23678
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.235910
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.
See 3 more
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.
See 4 more
Trial 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 (Brachytherapy)
- SpaceOAR Vue (Brachytherapy)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: SpaceOAR VueExperimental Treatment1 Intervention
Group II: BioProtect Balloon Implant SystemExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Procure Proton Therapy CenterSomerset, NJ
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Who Is Running the Clinical Trial?
Princeton ProCure management, LLC.Lead Sponsor
References
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.
Rectal Perforation by a Balloon Spacer: A Rare Cause of Rectal Perforation Addressed Endoscopically. [2022]Prostate cancer is the second most frequent cancer in men worldwide. Dose escalation is currently the standard of care for the treatment of prostate cancer with radiation therapy. However, the rectum tends to be the dose-limiting structure when treating prostate cancer, given its proximity. The injection of biodegradable spacers between the prostate and the rectum may optimize radiotherapy treatment delivery for patients with localized disease. Nevertheless, although the overall complication rate of spacers is marginal, the benefits of spacer technologies need to be evaluated against the complication risks such as rectum perforation/necrosis. We report a case of a 59-year-old man with a diagnosis of prostate adenocarcinoma for whom hormonal treatment followed by intensity modulated radiation therapy (IMRT) was proposed. A biodegradable and expandable balloon (BioProtect®) was injected into the perirectal space without detectable immediate complications. One month later, the patient presented with a 3-day persistent rectal bleeding. The investigation confirmed a rectal perforation by the balloon spacer system.
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.
[Prostate-rectum spacers: optimization of prostate cancer irradiation]. [2018]In the curative radiotherapy of localized prostate cancer, improvements in biochemical control observed with dose escalation have been counterbalanced by an increase in radiation-induced toxicity. The injection of biodegradable spacers between prostate and rectum represents a new frontier in the optimization of radiotherapy treatments for patients with localized disease. Transperineal injection of different types of spacers under transrectal ultrasound guidance allows creating a 7-to-20 mm additional space between the prostate and the anterior rectal wall lasting 3 to 12 months. Dosimetrically, a relative reduction in the rectal volume receiving at least 70 Gy (V70) in the order of 43% to 84% is observed with all types of spacers, regardless of the radiotherapy technique used. Preliminary clinical results show for all spacers a good tolerance and a possible reduction in the acute side effects rate. The aim of the present systematic review of the literature is to report on indications as well as dosimetric and clinical advantages of the different types of prostate-rectum spacers commercially available (hydrogel, hyaluronic acid, collagen, biodegradable balloon).
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]Purpose: SpaceOAR® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity. Despite a high safety performance in initial trials, SpaceOAR remains in early clinical use. Thus, we examined emerging safety reports as the system becomes more widely utilized. Methods: We reviewed the SpaceOAR manufacturer website for the safety profile and complications associated with the SpaceOAR hydrogel. We then compared this with reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database. Results: The manufacturer website reported risks including pain, needle penetration, and/or gel injection into a nearby organ or blood vessel, local inflammation, infection, urinary retention, and local rectal injury or symptoms. There were 22 unique reports discussing 25 patient cases in the MAUDE database from January 2015 to March 2019, with an increasing number of reports each year up through 2018. Unique major complications including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis, purulent perineal drainage, rectal wall erosion, and rectourethral fistula were reported. Conclusion: Despite well-documented clinical benefits of the SpaceOAR System, there are a number of severe and debilitating complications recently reported in proximity to gel injection. This highlights the need for further study of device complications in light of its increasing clinical use.
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.
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.
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.
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.