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

ID#: NCT05224869

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 03, 2021

End Date: August 01, 2026

Contact Information:
Richard G Stock
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.

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