SpaceIT Hydrogel System for Perirectal Spacing

Trial Title: SpaceIT Hydrogel System for Perirectal Spacing

NCT ID: NCT06451614

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: SpaceIT Hydrogel System
Description: 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.
Arm group label: SpaceIT Hydrogel System

Intervention type: Device
Intervention name: Commercially available Boston Scientific Spacer
Description: 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.
Arm group label: Commercially available Boston Scientific Spacer

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

Criteria for eligibility:
Criteria:
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

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Baptist Hospital of Miami

Address:
City: Miami
Zip: 33176
Country: United States

Status: Recruiting

Contact:
Last name: Marcio Fagundes, MD

Contact backup:
Last name: Britney Rushton

Start date: October 30, 2024

Completion date: March 31, 2028

Lead sponsor:
Agency: Boston Scientific Corporation
Agency class: Industry

Source: Boston Scientific Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06451614