SpaceIT Hydrogel System for Perirectal Spacing

NCT06451614 | Active Not Recruiting FDA Device

• 1 other identifier: U0755
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 26

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Acute Grade 3 or greater adverse events.

  Acute Grade 3 or greater adverse events, inclusive of all adverse events listed on the existing SpaceOAR product labels, that arise within 90 days of index procedure.

  90 Days from hydrogel placement procedure

• Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose

  Clinically relevant dose reduction defined as a 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose in subjects receiving hydrogel.

  10 days post procedure

Secondary Outcomes (13)

• Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications

  Up to 24 months

• Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)

  Up to 90 days

• Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)

  91 days up to 24 Months

• Additional Effectiveness Endpoint - Visualization of hydrogel

  10 days post procedure

• Additional Effectiveness Endpoint - Space Creation

  10 days post procedure

Study Arms (2)

SpaceIT Hydrogel System

EXPERIMENTAL

Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.

Device: SpaceIT Hydrogel System

Commercially available Boston Scientific Spacer

ACTIVE COMPARATOR

Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device.

Device: Commercially available Boston Scientific Spacer

Interventions

SpaceIT Hydrogel System DEVICE

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.

SpaceIT Hydrogel System

Commercially available Boston Scientific Spacer DEVICE

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.

Commercially available Boston Scientific Spacer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (26)

Orange County Urology Associates

Laguna Hills, California, 92653, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Associated Urological Specialists

Chicago Ridge, Illinois, 60415, United States

Location

UroPartners

Glenview, Illinois, 60026, United States

Location

Springfield Clinic, LLC

Springfield, Illinois, 62701, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Integrated Medical Professionals

New York, New York, 10016, United States

Location

Perlmutter Cancer Center - NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

University Hospitals of Cleveland-Hospital

Cleveland, Ohio, 44106, United States

Location

Mercy Cancer Center Bon Secours Mercy Healt

Elyria, Ohio, 44035, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Gibbs Cancer Center and Research Institute

Greer, South Carolina, 29650, United States

Location

Midtown Urology Associates

Austin, Texas, 78705, United States

Location

University of Texas, Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Rio Grande Urology

El Paso, Texas, 79912, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Evergreen Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

University of Washington Medical Center-Hospital

Seattle, Washington, 98195, United States

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre-Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Brian Baumann, MD

  Springfield Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 11, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (23); CA (3)