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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpaceOAR Vue | Experimental |
| |
| BioProtect Balloon Implant System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpaceOAR Vue | Device | Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perirectal distance | Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation. | 2-4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spacer stability over time | Evaluated by spacer's height (mm) measurements taken at the last radiation treatment day. | 2-4 months |
| Mean rectal dose | Spacers effect on the exposure of the rectum to radiation (rV 70) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Soffen, MD | Contact | (732)-357-2623 | edward.soffen@asterahealthcare.org | |
| Heba Darwish | Contact | Heba.Darwish@procure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Procure Proton Therapy Center | Recruiting | Somerset | New Jersey | 08873 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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|
| BioProtect Balloon Implant System | Device | 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. |
|
| 2-4 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |