RECRUITING

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-06
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06594887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Edward Soffen, MD
CONTACT
(732)-357-2623
edward.soffen@asterahealthcare.org
Heba Darwish
CONTACT
Heba.Darwish@procure.com

Study Locations (Sites)

Procure Proton Therapy Center
Somerset, New Jersey, 08873
United States

Collaborators and Investigators

Sponsor: Princeton ProCure management, LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-06
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-09-06
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer