COMPLETED

Rectal Spacer for Prostate Cancer Radiation Image Guidance

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

The purpose of the study is to determine if a radiopaque hydrogel rectal spacer, SpaceOAR Vue®, can be used in place of fiducial markers when aligning patients for radiotherapy. The investigator hypothesizes that the alignment of the patient based on the rectal spacer will be similar to the alignment of the patient with fiducial markers.

Official Title

Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance

Quick Facts

Study Start:2024-03-08
Study Completion:2025-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05650021

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:Not specified
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * To be eligible for the study, you must have already had SpaceOAR and fiducial markers placed before undergoing prostate radiotherapy, or you should have a plan to have them placed.
  2. * Untreated cT1 - cT3 prostate cancer
  1. * Extracapsular extension of prostate cancer
  2. * Prior prostatectomy

Contacts and Locations

Principal Investigator

Joseph Miccio, MD
PRINCIPAL_INVESTIGATOR
Penn State Caner Institute

Study Locations (Sites)

Penn State Cancer Institute
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Joseph Miccio, MD, PRINCIPAL_INVESTIGATOR, Penn State Caner Institute

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 Date2024-03-08
Study Completion Date2025-09-15

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2025-09-15

Terms related to this study

Keywords Provided by Researchers

  • fiducial marker
  • SpaceOAR

Additional Relevant MeSH Terms

  • Prostate Cancer