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SpaceOAR Vue and fiducial marker for Prostate Cancer

N/A

Recruiting

Led By Joseph Miccio, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

"This trial is trying to see if a special gel called SpaceOAR Vue® can be used instead of markers to help line up patients for radiation treatment. The researchers believe that using the gel will work

Who is the study for?

This trial is for men with untreated prostate cancer stages cT1 to cT3. Participants must either already have the SpaceOAR and fiducial markers placed or plan to get them before starting radiotherapy.Check my eligibility

What is being tested?

The study tests if a radiopaque hydrogel rectal spacer, called SpaceOAR Vue®, can replace fiducial markers for patient alignment during prostate cancer radiotherapy treatments.See study design

What are the potential side effects?

Potential side effects are not specified in the provided information. Generally, side effects from similar procedures may include discomfort at the injection site or reaction to materials used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cone beam CT alignment

Trial Design

1Treatment groups

Experimental Treatment

Group I: SpaceOAR Vue and fiducial markerExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,844 Total Patients Enrolled

3 Trials studying Prostate Cancer

82 Patients Enrolled for Prostate Cancer

Joseph Miccio, MDPrincipal InvestigatorPenn State Caner Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment of participants currently ongoing for this clinical trial?

"Indeed, data available on clinicaltrials.gov highlights that this investigation is actively seeking out candidates. Initially disclosed on March 8th, 2024, with the most recent update done on March 18th, 2024, this trial aims to enlist a total of 30 participants from just one location."

Answered by AI

What is the current number of individuals being included in this clinical trial?

"Indeed, the details on clinicaltrials.gov imply that this investigation is actively seeking suitable candidates. The trial was initially listed on March 8th, 2024 and underwent its most recent revision on March 18th, 2024. A total of 30 individuals are being sought at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rectal Spacer for Prostate Cancer Radiation Image Guidance

Joseph Miccio 2024. "Rectal Spacer for Prostate Cancer Radiation Image Guidance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650021.