SpaceIT Hydrogel System for Perirectal Spacing

Launched by BOSTON SCIENTIFIC CORPORATION · Jun 4, 2024

Keywords

ClinConnect Summary

The SpaceIT Hydrogel System clinical trial is studying a new approach to help patients with prostate cancer who are receiving External Beam Radiotherapy (EBRT). This study aims to see if the SpaceIT Hydrogel is safe and effective in creating space around the prostate area, which may help reduce side effects from radiation treatment. The trial is currently recruiting male participants aged 18 and older who have been diagnosed with a specific type of prostate cancer and plan to undergo EBRT.

To participate, candidates must have a confirmed diagnosis of invasive prostate cancer and meet certain health criteria, such as having a Gleason Score of 7 or lower and specific levels of prostate-specific antigen (PSA). During the trial, participants will receive the hydrogel, and researchers will monitor their safety and treatment outcomes. It’s important to note that there are certain conditions that might exclude individuals from participating, such as having a large prostate or certain previous treatments. Overall, this trial aims to improve the treatment experience for men undergoing radiation therapy for prostate cancer.

Gender

MALE

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
• • 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