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NCT06599476 | RECRUITING | Prostate Cancer

Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Sponsor:

Advanced Radiation Centers of New York

Information provided by (Responsible Party):

Shawn Zimberg, MD

Brief Summary:

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits: * Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1,3,and 6-months FU visits.

Condition or disease

Prostate Cancer

Intervention/treatment

BioProtect Balloon Implant™ System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
Actual Study Start Date : 2024-05-21
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients with prostate cancer ≥ 18 years of age.
  • 2. Patients are in one of the following risk groups
    • * T1-T3 prostate cancer with no posterior extra capsular extension
    • * Gleason score ≤ 7
    • 3. Planned for radiation treatment with rectal spacer.
    • 4. Ability to understand and the willingness to sign a written informed consent form.
    Exclusion Criteria
    • 1. Metastatic disease.
    • 2. Previously treated localized adenocarcinoma of the prostate.
    • 3. Active Inflammatory bowel disease requiring treatment with steroids.
    • 4. Prior total prostatectomy.
    • 5. Current urinary tract infection.
    • 6. Acute or chronic prostatitis.
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Location Details

NCT06599476

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Advanced Radiation Centers of New York

New Hyde Park, New York, United States, 11042