Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
Public ClinicalTrials.gov record NCT05224869. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Non-Randomized Phase II Study of the Reduction in Rectal V100 With the Use of Rectal Spacer Hydrogel in the Management of Intermediate Risk Prostate Cancer Treated With Combined Modality Radiation Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05224869
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Interventions
- Medical Device Usage and Evaluation Device
- CT simulation Procedure
- Stereotactic body radiation therapy Procedure
- Brachytherapy Radiation
- Post-implant dosimetry scan Procedure
Device · Procedure · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2021
- Primary completion
- Jan 28, 2025
- Completion
- Jan 28, 2025
- Last update posted
- Feb 25, 2025
2021 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05224869, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 25, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05224869 live on ClinicalTrials.gov.