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Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer

NCT05224869 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-26

No results posted yet for this study

Summary

This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.

Conditions

Interventions

DEVICE

Medical Device Usage and Evaluation

Undergo hydrogel rectal spacer placement

PROCEDURE

CT simulation

CT simulation of radiation treatment planning 2-7 days after hydrogel placement

PROCEDURE

Stereotactic body radiation therapy

SBRT in 5 fractions over 1 week, 7 days after CT simulation

RADIATION

Brachytherapy

one month after completing SBRT

PROCEDURE

Post-implant dosimetry scan

one month after brachytherapy

Sponsors & Collaborators

Principal Investigators

  • Richard Stock · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2025-01-29
Completion
2025-01-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05224869 on ClinicalTrials.gov