SpaceIT Hydrogel System for Perirectal Spacing

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.

Key facts

Study ID: NCT06451614
Run by: Boston Scientific Corporation
People needed: 230
Starts: 2024-10-30
Expected to finish: 2028-03-31
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet the following criteria to be eligible for participation in the study:
Age ≥18 years old
Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H\&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
Subjects must meet ALL of the following:
Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
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)
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

You may not qualify if…

Prostate > 80 cc
Subjects who are planning to undergo brachytherapy or focal boost
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
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
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
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
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
History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery
History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
Bleeding hemorrhoids requiring medical intervention within the prior three months
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
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
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
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
Unable to comply with the study requirements or follow-up schedule
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
Known PEG (polyethylene glycol) sensitivity or allergy
Known iodine sensitivity or allergy
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

Where it is running

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
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
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

Full record on ClinicalTrials.gov

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