Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06594887

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Led by Princeton ProCure management, LLC. · Updated on 2024-09-19

50

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Procure Proton Therapy Center

Somerset, New Jersey, United States, 08873

Actively Recruiting

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Research Team

E

Edward Soffen, MD

CONTACT

H

Heba Darwish

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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