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Back|NCT06451614Recruiting
Official Title

SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)

Sponsor
Boston Scientific Corporation
Enrollment
230
Timeline
Oct 2024 → Mar 2028
About This Study

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

  • 1Subjects must meet the following criteria to be eligible for participation in the study:
  • 2Age ≥18 years old
  • 3Subjects must have had pathologically confirmed (by routine hematoxylin and eosin \[H\&E\] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
  • 4Subjects must meet ALL of the following:
  • 5Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
  • 6Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
  • 7Demonstrated 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)
  • 8Subject 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

  • 1Prostate \> 80 cc
  • 2Subjects who are planning to undergo brachytherapy or focal boost
  • 3Subjects 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
  • 4Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned
  • 5Subjects 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
  • 6History 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
  • 7History 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
  • 8History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery
  • 9History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
  • 10Bleeding hemorrhoids requiring medical intervention within the prior three months
  • 11Diagnosed 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
  • 12Active 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
  • 13Inability 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
  • 14If 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
  • 15Unable to comply with the study requirements or follow-up schedule
  • 16Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient
  • 17Known PEG (polyethylene glycol) sensitivity or allergy
  • 18Known iodine sensitivity or allergy
  • 19ADT, 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

Locations

28 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30308

Recruiting

Sagar Patel, MD

Orange County Urology Associates

Laguna Hills, California 92653

Recruiting

Daniel Su, MD

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

Recruiting

Albert Chang, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →