Rectal Spacers Use in Prostate Cancer Radiation Therapy

Launched by PRINCETON PROCURE MANAGEMENT, LLC. · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how using a special device called a rectal spacer can help patients with localized prostate cancer who are about to receive Proton Beam Therapy (PBT). The trial will involve up to 50 men, aged 65 to 74, who have been diagnosed with prostate cancer and meet certain health criteria. To be eligible, participants must have a specific type of prostate cancer confirmed by a biopsy and must not have any advanced disease or previous treatments that could affect the study.

During the trial, participants will go through several visits, including a screening to make sure they qualify, the placement of the rectal spacer, treatment planning, and follow-up assessments at 1, 3, and 6 months after treatment. The rectal spacer is designed to help protect nearby organs during radiation therapy. If you or a loved one are considering participation, it’s important to understand the eligibility criteria and the process involved, as well as the commitment required for follow-up visits.

Gender

MALE

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.