Rectal Spacers Use in Prostate Cancer Radiation Therapy

NCT06594887 | Recruiting FDA Device

• 1 other identifier: 1378387
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Perirectal distance

  Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.

  2-4 months

Secondary Outcomes (2)

• Spacer stability over time

  2-4 months

• Mean rectal dose

  2-4 months

Study Arms (2)

SpaceOAR Vue

EXPERIMENTAL

Device: SpaceOAR Vue

BioProtect Balloon Implant System

EXPERIMENTAL

Device: BioProtect Balloon Implant System

Interventions

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

Also known as: Hydrogel

SpaceOAR Vue

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.

BioProtect Balloon Implant System

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Princeton ProCure management, LLC.: lead

Study Sites (1)

Procure Proton Therapy Center

Somerset, New Jersey, 08873, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Central Study Contacts

Edward Soffen, MD

CONTACT

(732)-357-2623; edward.soffen@asterahealthcare.org

Heba Darwish

CONTACT

Heba.Darwish@procure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edward M. Soffen, M.D.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: September 6, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

US (1)