Using rectal spacers during radiation therapy for prostate cancer

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

This study is testing whether using rectal spacers during radiation therapy can help men with localized prostate cancer have better treatment results and fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Princeton ProCure management, LLC. (Academic / other)
• Locations: 1 site (Somerset, New Jersey)
• Trial ID: NCT06594887 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of rectal spacers in patients with localized prostate cancer who are scheduled to receive Proton Beam Therapy (PBT). The study will enroll up to 50 participants and will involve several visits for screening, spacer placement, treatment planning, and follow-up assessments at 1, 3, and 6 months post-treatment. The aim is to determine if the use of rectal spacers can improve treatment outcomes and reduce side effects associated with radiation therapy.

Who should consider this trial

Good fit: Ideal candidates are adult males over 18 years old with localized prostate cancer who are planning to undergo Proton Beam Therapy.

Not a fit: Patients with metastatic disease or those who have previously undergone local prostate cancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the safety and effectiveness of radiation therapy for prostate cancer patients.

How similar studies have performed: Other studies have shown promising results with the use of rectal spacers in radiation therapy, indicating a potential for success in this approach.

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.

Where this trial is running

Somerset, New Jersey

• Procure Proton Therapy Center — Somerset, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Edward Soffen, MD

Conditions Prostate Cancer