Rectal Spacers Use in Prostate Cancer Radiation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SpaceOAR Vue, BioProtect Balloon Implant System.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Perirectal distance [Time frame: 2-4 months]
Secondary outcome measures (2)
- Spacer stability over time [Time frame: 2-4 months]
- Mean rectal dose [Time frame: 2-4 months]
Eligibility criteria
Inclusion criteria
- Subjects greater than 18 years old with prostate cancer
- 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
- Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
- PSA less than or equal to 20 ng/mL
- Gleason Score less than or equal to 7
- Capacity to comprehend and readiness to sign a written informed consent form
Exclusion criteria
- Planned Pelvic lymph node radiotherapy.
- Metastatic disease.
- Prior local prostate cancer therapy
- Active Inflammatory bowel disease requiring treatment with steroids.
- Prior radical prostatectomy.
- Active urinary tract infection.
- Acute or chronic inflammation or infection of the prostate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Procure Proton Therapy Center — Somerset
Identifiers
NCT: NCT06594887 · 1378387