Status:
TERMINATED
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 ge...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05224869
Start Date
August 31 2021
End Date
January 29 2025
Last Update
February 26 2025
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029