Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
230 participants
INTERVENTIONAL
2024-10-30
2028-03-31
Brief Summary
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Detailed Description
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Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System
Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SpaceIT Hydrogel System
Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.
SpaceIT Hydrogel System
SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use.
SpaceIT has an iodinated PEG powder making it radiopaque.
Commercially available Boston Scientific Spacer
Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device.
Commercially available Boston Scientific Spacer
Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Interventions
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SpaceIT Hydrogel System
SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use.
SpaceIT has an iodinated PEG powder making it radiopaque.
Commercially available Boston Scientific Spacer
Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years old
2. Subjects must have had pathologically confirmed (by routine hematoxylin and eosin \[H\&E\] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
3. Subjects must meet ALL of the following:
1. Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
2. Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
3. Demonstrated blood prostate specific antigen (PSA) levels ≤20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT)
4. Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site
Exclusion Criteria
2. Subjects who are planning to undergo brachytherapy or focal boost
3. Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit
4. Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned
5. Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years
6. History of radical prostatectomy, other ablative anti-prostate cancer therapy (e.g., cryotherapy, high intensity focused ultrasound, irreversible electroporation) or previous pelvic irradiation (including prior prostate brachytherapy) at any time prior to screening
7. History of transurethral prostate surgery (e.g., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (TURP)) if performed within 1 year prior to screening
8. History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery
9. History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
10. Bleeding hemorrhoids requiring medical intervention within the prior three months
11. Diagnosed active bleeding disorder or a clinically significant coagulopathy, defined as PTT \> 70s or aPTT\>35s or INR \> 1.4, or platelet count \< 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure
12. Active inflammatory or infectious process involving the perineum, GI or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever \>38⁰ C, WBC \> 12,000/uL
13. Inability to undergo pelvic MRI or presence of implants causing severe artifact (e.g. bilateral arthroplasty) that interferes with imaging interpretation for this study at Investigator discretion
14. If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study
15. Unable to comply with the study requirements or follow-up schedule
16. Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient
17. Known PEG (polyethylene glycol) sensitivity or allergy
18. Known iodine sensitivity or allergy
19. ADT, if applicable, cannot or was not started 15-60 days prior to the pre-index procedure RT planning imaging and is planned to continue for a total planned duration greater than 6 months
18 Years
MALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Baumann, MD
Role: PRINCIPAL_INVESTIGATOR
Springfield Clinic
Locations
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City of Hope
Duarte, California, United States
Orange County Urology Associates
Laguna Hills, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Baptist Hospital of Miami
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
UroPartners
Glenview, Illinois, United States
Springfield Clinic, LLC
Springfield, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Integrated Medical Professionals
New York, New York, United States
Perlmutter Cancer Center - NYU Langone
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Northwell Health
New York, New York, United States
University Hospitals of Cleveland-Hospital
Cleveland, Ohio, United States
Mercy Cancer Center Bon Secours Mercy Healt
Elyria, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Gibbs Cancer Center and Research Institute
Greer, South Carolina, United States
Midtown Urology Associates
Austin, Texas, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Rio Grande Urology
El Paso, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
University of Washington Medical Center-Hospital
Seattle, Washington, United States
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre-Hospital
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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U0755
Identifier Type: -
Identifier Source: org_study_id
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