Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 10 people enrolled
- Started
- 31 Aug 2021
- Ended
- 29 Jan 2025
- Type of study
- Interventional
- Treatments tested
- Medical Device Usage and Evaluation
- CT simulation
- Stereotactic body radiation therapy
- Brachytherapy
- Post-implant dosimetry scan
- Record updated
- 26 February 2025
- Why it stopped
- Was not meeting target enrollment; other treatment options precluded completing study
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 receiving antiandrogen therapy (ADT)
- Patients with any prior active or treated genitourinary malignancy
- Patients with disease not confined to the prostate based on imaging, biopsy, or clinical exam
- 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 with a prostate size > 100 cc based on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound measurements
Where in United States
- Mount Sinai HospitalNew York, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients with prostate cancerTreatment being tested
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,
Treatment: Medical Device Usage and Evaluation, CT simulation, Stereotactic body radiation therapy, Brachytherapy, and Post-implant dosimetry scan
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 26 February 2025