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

NCT ID: NCT05224869

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2025-01-29

Brief 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.

Detailed Description

The purpose of this research study is to observe the effects of using an FDA-approved rectal spacer device known as the SpaceOAR Hydrogel, which 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 will stay 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 will help spare the rectum from receiving radiation during the standard of care stereotactic body radiation treatment participant will be receiving, along with the brachytherapy treatment. The hydrogel rectal spacer has been shown to be very safe and effective at reducing radiation dose to the rectum during external radiation treatments, but has not been well-studied when using a combination of Stereotactic Body Radiation Therapy (SBRT) and brachytherapy. The goal of this research is to determine how effective the SpaceOAR hydrogel rectal spacer is at decreasing radiation side effects that can occur in the rectum, which can include discomfort or bleeding. The researchers also want to see how the use of this device affects the doctor's ability to perform the brachytherapy implant safely and effectively.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with prostate cancer

Patients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy,

Group Type: EXPERIMENTAL

Medical Device Usage and Evaluation

Intervention Type: DEVICE

Undergo hydrogel rectal spacer placement

CT simulation

Intervention Type: PROCEDURE

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

Stereotactic body radiation therapy

Intervention Type: PROCEDURE

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

Brachytherapy

Intervention Type: RADIATION

one month after completing SBRT

Post-implant dosimetry scan

Intervention Type: PROCEDURE

one month after brachytherapy

Interventions

Medical Device Usage and Evaluation

Undergo hydrogel rectal spacer placement

Intervention Type: DEVICE

CT simulation

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

Intervention Type: PROCEDURE

Stereotactic body radiation therapy

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

Intervention Type: PROCEDURE

Brachytherapy

one month after completing SBRT

Intervention Type: RADIATION

Post-implant dosimetry scan

one month after brachytherapy

Intervention Type: PROCEDURE

Other Intervention Names

Hydrogel rectal spacer; SpaceOAR Hydrogel; SBRT

Eligibility Criteria

Inclusion Criteria

• Histologically/biopsy confirmed adenocarcinoma of prostate within 1 year of registration
• Disease confined to the prostate. Prostate volume must be <150cc confirmed by pelvic CT (with or without contrast) or pelvic/prostate MRI (with or without contrast) +/- ultrasound, within 8 months of signing research consent
• Age >18
• Patients deemed medically suitable to undergo rectal spacer placement, external beam radiotherapy and brachytherapy at the discretion of the radiation oncologist, urologist, medical oncologist and/or internist.
• ECOG score of 0-2.
• One or more of the following risk factors for intermediate risk prostate cancer; T2b or T2c clinical stage, GS 7 (either 3+4 or 4+3), PSA 10-20.
• Ability to understand and the willingness to sign a written informed consent.
• PSA result within 6 months of simulation

Exclusion Criteria

• Patients with disease not confined to the prostate based on imaging, biopsy, or clinical exam
• Patients with a prostate size > 100 cc based on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound measurements
• Patients who have undergone previous rectal, bowel, bladder, or prostate surgeries in the past
• Patients with previous treatments for their prostate cancer or that are currently receiving any other experimental therapies
• Patients who have undergone prior pelvic radiotherapy
• Patients with high risk prostate cancer that have any of the following risk factors; GS >= 8, PSA > 20, clinical or imaging stage T3a or higher
• Patients receiving antiandrogen therapy (ADT)
• Patients with any prior active or treated genitourinary malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Richard Stock

Professor, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Stock

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Countries

United States

References

Nehlsen AD, Sindhu KK, Moshier E, Sfakianos JP, Stock RG. The impact of a rectal hydrogel spacer on dosimetric and toxicity outcomes among patients undergoing combination therapy with external beam radiotherapy and low-dose-rate brachytherapy. Brachytherapy. 2021 Mar-Apr;20(2):296-301. doi: 10.1016/j.brachy.2020.09.018. Epub 2020 Nov 13.

Reference Type: BACKGROUND

PMID: 33199175 (View on PubMed)

Other Identifiers

GCO 21-0603

Identifier Type: -

Identifier Source: org_study_id