Clinical trial NCT05224869: Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Brachytherapy
Radioactive Seed implant
Rectal Spacer
SpaceOAR
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of participants that achieve V100rectum < 0.75 cc
timeFrame: At 1 month post-brachytherapy (at about 2 months)
Secondary outcomes:
measure: D90prostate
timeFrame: At the time of post-implant dosimetry (at about 3 months)
measure: V150prostate
timeFrame: At the time of post-implant dosimetry (at about 3 months)
measure: Number of participants with anatomic distortions
timeFrame: At the time of the brachytherapy implant (at about 2 months)
measure: Number of participants with radiographic distortion
timeFrame: At the time of the brachytherapy implant (at about 2 months)
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Baseline and up to 2 years post-treatment
measure: Change in Sexual Health Index in Men (SHIM)
timeFrame: Baseline and up to 2 years post-treatment
measure: Change in Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline and up to 2 years post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Richard Stock
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.