Rectal Spacer for Prostate Cancer Radiation Image Guidance

NCT05650021 | Completed FDA Device

• 1 other identifier: PSCI-21-158
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

fiducial marker; SpaceOAR

Outcome Measures

Primary Outcomes (1)

• Cone beam CT alignment

  The radiation oncologist will measure the difference in anterior/posterior, superior/inferior, and lateral shifts between the cone beam CT alignment completed with fiducial markers and the cone beam CT alignment completed with the radiopaque hydrogel rectal spacer.

  8 weeks

Study Arms (1)

SpaceOAR Vue and fiducial marker

OTHER

After enrollment, patients will be treated per the standard of care, including the use of daily CBCT for image guided radiotherapy. The investigator will review the CBCT on the first day of treatment and align in such a way that the fiducials match up but also that the radio-opaque SpaceOAR lines up to within 5mm. If the SpaceOAR does not line up to within 5mm, the investigator will consider an intervention such as having the patient get off the table to pass gas, have a bowel movement, additional counseling about diet and bowel movement habits, or potentially even re-simulation. These daily CBCT images are aligned to the CT simulation images by way of aligning the fiducial markers on the respective imaging data sets. The CBCT images acquired during their first five fractions of radiotherapy will be imported into MIM software.

Device: SpaceOAR Vue

Interventions

SpaceOAR Vue DEVICE

CBCT images acquired during the first five fractions of radiotherapy

Also known as: Fiducial marker

SpaceOAR Vue and fiducial marker

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Untreated cT1 - cT3 prostate cancer

You may not qualify if:

• Extracapsular extension of prostate cancer
• Prior prostatectomy

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fiducial Markers

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reference Standards; Weights and Measures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Joseph Miccio, MD

  Penn State Caner Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: March 8, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)