SpaceOAR Vue System for Prostate Cancer
(SABRE Trial)
Recruiting in Palo Alto (17 mi)
+29 other locations
Overseen bySuneil Jain, MB, BCh, MRCP, FRCR, PhD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Scientific Corporation
Disqualifiers: Metastatic disease, Inflammatory bowel disease, Prostatectomy, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you may need to stop them for the procedure.
What data supports the effectiveness of the SpaceOAR Vue System treatment for prostate cancer?
Research shows that Stereotactic Body Radiotherapy (SBRT), a component of the treatment, is safe and effective for low- and intermediate-risk prostate cancer, with promising quality of life outcomes. Additionally, Stereotactic Ablative Radiotherapy (SABR) is feasible and well-tolerated for intermediate- and high-risk prostate cancer, although more data is needed for high-risk cases.
12345Is the SpaceOAR Vue System safe for use in humans?
Research on stereotactic body radiotherapy (SBRT), which is related to the SpaceOAR Vue System, shows that it is generally safe for treating prostate cancer, with safety established through various clinical trials.
24678How is the SpaceOAR Vue System with SBRT treatment for prostate cancer different from other treatments?
The SpaceOAR Vue System with SBRT is unique because it uses an iodinated rectal spacer to protect the rectum during radiation therapy, allowing for more precise targeting of the prostate cancer while minimizing damage to surrounding tissues. This approach is particularly beneficial for patients who cannot undergo MRI, as the spacer is visible on CT scans, aiding in accurate treatment planning.
910111213Eligibility Criteria
This trial is for men over 18 with invasive prostate cancer who plan to undergo SBRT. They must have a clinical stage T2b-T2c tumor, Gleason Score of 7, or PSA levels between 10-20 ng/ml. Exclusions include PSA >20 ng/ml, metastatic disease, prior malignancies (unless disease-free for 3 years), previous local prostate treatments or pelvic irradiation, compromised immune systems, large prostates (>80 cc), and certain medical conditions.Inclusion Criteria
I have been diagnosed with invasive prostate cancer and plan to undergo SBRT.
My prostate cancer is at an intermediate risk level.
I, or my authorized representative, have signed the consent form after understanding the study.
+1 more
Exclusion Criteria
Known polyethylene glycol (PEG) sensitivity or allergy
My prostate cancer biopsy shows a Gleason Score of 8 or higher.
My PSA level was over 20 ng/ml before starting hormone therapy.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Stereotactic Body Radiotherapy (SBRT) with or without the SpaceOAR Vue System
6-8 weeks
Follow-up
Participants are monitored for late gastrointestinal (GI) toxicity and changes in EPIC-26 bowel score
24 months
Participant Groups
The SpaceOAR Vue System is being tested to see if it can reduce late gastrointestinal side effects in patients receiving Stereotactic Body Radiotherapy (SBRT) for prostate cancer. The study will involve subjects using the system during their SBRT treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: SpaceOAR VueExperimental Treatment1 Intervention
Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.
Group II: No-Spacer ControlActive Control1 Intervention
Subjects will receive radiotherapy without the use of the SpaceOAR Vue.
Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:
- Early-stage lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
🇯🇵 Approved in Japan as Stereotactic Body Radiation Therapy for:
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Genesis Care, USALakewood Ranch, FL
University of Pittsburgh Medical CenterPittsburgh, PA
GenesisCare USATroy, MI
Kansas University Medical CenterKansas City, KS
More Trial Locations
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Who Is Running the Clinical Trial?
Boston Scientific CorporationLead Sponsor
References
Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life. [2021]Stereotactic body radiotherapy (SBRT) is an emerging treatment approach reported as safe and effective strategy for low- and intermediate-risk prostate cancer patients. End point of the current study is to appraise the patient-reported quality of life according to the expanded prostate cancer index composite (EPIC) questionnaire.
Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial. [2022]We report the outcome of a phase I/II clinical trial of stereotactic body radiation therapy (SBRT) for low (LR) and select intermediate risk (IR) prostate cancer (PCa) patients.
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]Stereotactic ablative radiotherapy (SABR) is a relatively novel form of high precision radiotherapy. For low- and intermediate risk patients, ultrahypofractionation (UHF - more than 5 Gy per day) has been compared to conventionally fractionated or moderately hypofractionated radiotherapy in two large randomized studies. A third smaller randomized study examined the question of the optimal frequency of treatments. The results of these studies will be reviewed. SABR for high risk prostate cancer has been shown to be feasible and is well tolerated with careful planning and setup techniques. However, there is currently insufficient data supporting its use for high-risk patients to offer SABR outside of a clinical trial. SABR costs less to the radiotherapydepartments and, the patient, as well as increasing system capacity. Therefore, it has the potential to be widely adopted in the next few years.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.
Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]The safety and efficacy of stereotactic body radiotherapy (SBRT) in localised prostate cancer are now established through phase III randomised trials. Its utility in node-positive prostate cancer is restricted due to a lack of controlled studies specifically addressing this subgroup. Herein we report the safety and efficacy of SBRT in this subgroup.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]There are no safety-focused trials on stereotactic body radiotherapy (SBRT) for localized prostate cancer. This prospective 3‑year phase II trial used binomial law to validate the safety and efficacy of SBRT with stringent organ at risk dose constraints that nevertheless permitted high planning target volume doses.
Utilization of Iodinated SpaceOAR Vue™ During Robotic Prostate Stereotactic Body Radiation Therapy (SBRT) to Identify the Rectal-Prostate Interface and Spare the Rectum: A Case Report. [2021]We describe the utilization of SpaceOAR Vue™, a new iodinated rectal spacer, during Robotic Stereotactic Body Radiation Therapy (SBRT) for a Prostate Cancer Patient with a contraindication to Magnetic Resonance Imaging. A 69-year-old Caucasian male presented with unfavorable intermediate risk prostate cancer and elected to undergo SBRT. His medical history was significant for atrial fibrillation on Rivaroxaban with a pacemaker. He was felt to be at increased risk of radiation proctitis following SBRT due to the inability to accurately contour the anterior rectal wall at the prostate apex without a treatment planning MRI and an increased risk of late rectal bleeding due to prescribed anticoagulants. In this case report, we discuss the technical aspects of appropriate placement and treatment planning for utilizing SpaceOAR Vue™ with Robotic SBRT.
Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes. [2020]Multiple phase I-II clinical trials have reported on the efficacy and safety of prostate stereotactic body radiotherapy (SBRT) for the treatment of prostate cancer. However, few have reported outcomes for prostate SBRT using periprostatic hydrogel spacer (SpaceOAR; Augmenix). Herein, we report safety and efficacy outcomes from our institutional prostate SBRT experience with SpaceOAR placement.
Bladder stone formation around polyethylene glycol after use of SpaceOAR Hydrogel. [2023]Label="Introduction" NlmCategory="UNASSIGNED">Radiation therapy is used as primary, adjuvant, and salvage therapy for prostate cancer. When using radiation therapy, the SpaceOAR® system is considered easy to use and useful for reducing the irradiated dose and toxicity to the rectum. Although SpaceOAR® system have been reported some adverse event including death.
Patient Reported Quality of Life Outcomes After Definitive Radiation Therapy With Absorbable Spacer Hydrogel for Prostate Cancer. [2023]SpaceOAR is a device approved for conventional radiation in prostate cancer. We sought to observe prospectively how SpaceOAR Hydrogel effected quality of life and dosimetry to organs at risk at our institution.
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.