Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05224869
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05224869
Study Brief:
Protocol Section:
NCT05224869