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

NCT05224869 | Terminated DMC FDA Device

• 1 other identifier: GCO 21-0603
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Brachytherapy; Radioactive Seed implant; Rectal Spacer; SpaceOAR

Outcome Measures

Primary Outcomes (1)

• The proportion of participants that achieve V100rectum < 0.75 cc

  Volume of the rectum receiving at least 100% of the prescribed dose (V100rectum) \< 0.75 cc rate will be estimated as the proportion of patients that achieve V100rectum \< 0.75 cc at the post-implant dosimetry computed tomography scan 1 month following brachytherapy along with a corresponding two-sided 90% confidence interval using the methods and software introduced by Koyama and Chen which accounts for the group sequential nature of the design

  At 1 month post-brachytherapy (at about 2 months)

Secondary Outcomes (7)

• D90prostate

  At the time of post-implant dosimetry (at about 3 months)

• V150prostate

  At the time of post-implant dosimetry (at about 3 months)

• Number of participants with anatomic distortions

  At the time of the brachytherapy implant (at about 2 months)

• Number of participants with radiographic distortion

  At the time of the brachytherapy implant (at about 2 months)

• Change in International Prostate Symptom Score (IPSS)

  Baseline and up to 2 years post-treatment

Study Arms (1)

Patients with prostate cancer

EXPERIMENTAL

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,

Device: Medical Device Usage and Evaluation; Procedure: CT simulation; Procedure: Stereotactic body radiation therapy; Radiation: Brachytherapy; Procedure: Post-implant dosimetry scan

Interventions

Medical Device Usage and Evaluation DEVICE

Undergo hydrogel rectal spacer placement

Also known as: Hydrogel rectal spacer, SpaceOAR Hydrogel

Patients with prostate cancer

CT simulation PROCEDURE

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

Patients with prostate cancer

Stereotactic body radiation therapy PROCEDURE

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

Also known as: SBRT

Patients with prostate cancer

Brachytherapy RADIATION

one month after completing SBRT

Patients with prostate cancer

Post-implant dosimetry scan PROCEDURE

one month after brachytherapy

Patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 33199175 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Physical Examination; Radiosurgery; Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Stock

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: August 31, 2021
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)