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SpaceIT Hydrogel System for Perirectal Spacing

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
  • 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

Join this Trial

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Study Stats
Protocol No.
24-6011
Category
Prostate Cancer
Contact
JACQUELINE HERNANDEZ
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06451614
For detailed technical eligibility, visit ClinicalTrials.gov.