Using a rectal spacer for prostate cancer radiation guidance
Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance
This study is testing if a new gel spacer can help doctors better target radiation treatment for prostate cancer compared to using tiny markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | Male |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05650021 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the SpaceOAR Vue®, a radiopaque hydrogel rectal spacer, as an alternative to fiducial markers for aligning patients undergoing radiotherapy for prostate cancer. The hypothesis is that the alignment achieved with the rectal spacer will be comparable to that obtained with fiducial markers. The study will involve patients who have either had these devices placed or are scheduled to have them placed prior to their treatment. The goal is to improve the precision of radiation delivery by addressing the variability in prostate positioning due to changes in rectal and bladder filling.
Who should consider this trial
Good fit: Ideal candidates include men with untreated cT1 - cT3 prostate cancer who have had or plan to have SpaceOAR and fiducial markers placed.
Not a fit: Patients with extracapsular extension of prostate cancer or those who have previously undergone prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of radiation therapy for prostate cancer, potentially leading to better treatment outcomes.
How similar studies have performed: While the use of fiducial markers is well-established, the application of a rectal spacer as a substitute is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Extracapsular extension of prostate cancer * Prior prostatectomy
Where this trial is running
Hershey, Pennsylvania
- Penn State Cancer Institute — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Miccio, MD — Penn State Caner Institute
- Study coordinator: Joseph Miccio, MD
- Email: jmiccio@pennstatehealth.psu.edu
- Phone: 717-531-8024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.