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Trial Title:
Rectal Spacers Use in Prostate Cancer Radiation Therapy
NCT ID:
NCT06594887
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
SpaceOAR Vue
Description:
Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue)
in order to outdistance the prostate from anterior rectal wall
Arm group label:
SpaceOAR Vue
Other name:
Hydrogel
Intervention type:
Device
Intervention name:
BioProtect Balloon Implant System
Description:
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.
Arm group label:
BioProtect Balloon Implant System
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Procure Proton Therapy Center
Address:
City:
Somerset
Zip:
08873
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heba Darwish
Email:
heba.darwish@procure.com
Start date:
September 6, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Princeton ProCure management, LLC.
Agency class:
Other
Source:
Princeton ProCure management, LLC.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06594887
