ClinicalTrials.gov ID: NCT06451614
Ages Eligible: 18 Years and Older
Sexes Eligible: Male
Study Phase: Interventional
Study Completion (Estimated): 2028-03-31
Principal Investigator: Alex Hsi, MD
Contact Information:
EvergreenHealth Research Department
425-899-5385
EvergreenResearch@evergreenhealthcare.org
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.
Eligibility Criteria:
Inclusion Criteria
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
Exclusion Criteria
- 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
