SpaceIT Hydrogel System for Perirectal Spacing

Prior treatment

• 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
• 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
• Bleeding hemorrhoids requiring medical intervention within the prior three months
• 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
• 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

Other illness

• 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 or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
• 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

Lab values

• 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

Other

• Prostate \> 80 cc
• Subjects who are planning to undergo brachytherapy or focal boost
• Unable to comply with the study requirements or follow-up schedule

• 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