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Purpose

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer 4. PSA less than or equal to 20 ng/mL 5. Gleason Score less than or equal to 7 6. Capacity to comprehend and readiness to sign a written informed consent form

Exclusion Criteria

  1. Planned Pelvic lymph node radiotherapy. 2. Metastatic disease. 3. Prior local prostate cancer therapy 4. Active Inflammatory bowel disease requiring treatment with steroids. 5. Prior radical prostatectomy. 6. Active urinary tract infection. 7. Acute or chronic inflammation or infection of the prostate.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SpaceOAR Vue
  • Device: SpaceOAR Vue
    Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall
    Other names:
    • Hydrogel
Experimental
BioProtect Balloon Implant System
  • Device: BioProtect Balloon Implant System
    The balloon spacer is a biodegradable balloon made of poly (L-Lactide-co-caprolactone) which is a co-polymer of Poly Lactide acid and epsilon Caprolactone (BioProtect Balloon Implant System, BioProtect Ltd) inflated with saline, providing around 18 mm space height , and can be deflated and repositioned if needed, both laterally and along the distal /proximal planes, for optimal uniformity of spacing.

Recruiting Locations

Procure Proton Therapy Center
Somerset, New Jersey 08873
Contact:
Heba Darwish
heba.darwish@procure.com

More Details

Status
Recruiting
Sponsor
Princeton ProCure management, LLC.

Study Contact

Edward Soffen, MD
(732)-357-2623
edward.soffen@asterahealthcare.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.