SpaceIT Hydrogel System for Perirectal Spacing

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: SpaceIT Hydrogel System; Device: Commercially available Boston Scientific Spacer

• Registration Number: NCT06451614
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.

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

Study Timeline

• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Study Start: 2024-10-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 230

Inclusion Criteria

Subjects must meet the following criteria to be eligible for participation in the study:

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

1. Prostate > 80 cc
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpaceIT Hydrogel System	SpaceIT Hydrogel System	Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.
Commercially available Boston Scientific Spacer	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Acute Grade 3 or greater adverse events.	90 Days from hydrogel placement procedure	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.
Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose	10 days post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)	Up to 90 days	Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs) from index procedure up to 3 months
Additional Effectiveness Endpoint - Change in radiation dose distributions to the organs at risk	10 days post procedure	Dose Distribution: Change in radiation dose distributions to the organs at risk (OARs) quantified by computing rectal Dose-Volume Histograms (DVHs) for the dose plans created pre-and post-hydrogel placement.
Additional Effectiveness Endpoint - Quality of Life Questionnaire, Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)	Baseline up to 24 months	Changes from Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH); The Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Additional Effectiveness Endpoint - Absorption	12 Month post hydrogel placement	Absorption: Absence of hydrogel in the perirectal space assessed on MRI at 12 months post-hydrogel placement.
Additional Effectiveness Endpoint - Mean and Maximum Rectal Radiation doses	10 days post procedure	Mean and Maximum Rectal Radiation Doses (in Gy)
Additional Effectiveness Endpoint - Quality of Life Questionnaire: EQ-5D-5L	Baseline up to 24 months	Changes from Baseline in EQ-5D-5L; The EQ-5D-5L is a generic questionnaire that assesses a subject's self-reported health status in terms of five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Subject's overall current health on a vertical visual analogue scale of "0-100" is recorded, where the endpoints are labelled 'The best health you can imagine' at "100" and 'The worst health you can imagine' at "0".
Additional Effectiveness Endpoint - Ease of hydrogel administration	10 days post procedure	Ease of hydrogel administration. Scored on a Likert scale from 1 to 5 where 1 is Very Difficult and 5 is Very Easy
Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications	Up to 24 months	Adverse Device Effects (ADEs) requiring additional procedures and/or medications
Additional Effectiveness Endpoint - Visualization of hydrogel	10 days post procedure	Technical Success: visualization of hydrogel between the posterior prostatic capsule and the anterior rectal wall will be assessed as Yes/No using the MRI performed post hydrogel placement procedure
Additional Effectiveness Endpoint - Space Creation	10 days post procedure	Space Creation: Distance between the posterior prostatic capsule and anterior rectal wall will be measured mid gland in millimeters using MRI performed post hydrogel placement procedure
Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)	91 days up to 24 Months	Incidence of late Grade 2 or greater GI and GU adverse events (AEs) from 3 months up to the end of study follow-up
Additional Effectiveness Endpoint - Space Maintenance	3 Months post hydrogel placement procedure	Space Maintenance: Distance between the posterior prostatic capsule and anterior rectal wall will be measured
Additional Effectiveness Endpoint - Quality of Life Questionnaire: Expanded Prostate Cancer Index Composite (EPIC-26)	Baseline up to 24 months	Changes from Baseline in Expanded Prostate Cancer Index Composite (EPIC-26); EPIC-26 is a questionnaire designed to measure health related quality of life (HRQOL) in people with prostate cancer. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

Trial Locations

Locations (13)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

UroPartners; 🇺🇸 Glenview, Illinois, United States

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States

Orlando Health Cancer Institute; 🇺🇸 Orlando, Florida, United States

Associated Urological Specialists; 🇺🇸 Chicago Ridge, 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

MidLantic Urology; 🇺🇸 Bala Cynwyd, Pennsylvania, United States

Gibbs Cancer Center and Research Institute; 🇺🇸 Greer, South Carolina, United States

Houston Metro Urology; 🇺🇸 Houston, Texas, United States

Evergreen Hospital Medical Center; 🇺🇸 Kirkland, Washington, United States