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NCT Number: NCT06594887

Rectal Spacers Use in Prostate Cancer Radiation Therapy

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Procure Proton Therapy Center

Somerset, New Jersey, 08873, United States

Location status: Recruiting

Location contact

Heba Darwish

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Hydrogel

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.

Primary outcomes

  1. Perirectal distance

    Time frame: 2-4 months

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

Secondary outcomes

  1. Spacer stability over time

    Time frame: 2-4 months

    Evaluated by spacer's height (mm) measurements taken at the last radiation treatment day.

  2. Mean rectal dose

    Time frame: 2-4 months

    Spacers effect on the exposure of the rectum to radiation (rV 70)

Study contacts

Contact information is provided by the study sponsor or research team.

Edward Soffen, MD

CONTACT

[email protected]

(732)-357-2623

Heba Darwish

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Princeton ProCure management, LLC.

Other

Registry information

Official study title

Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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