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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT03541850
Eligibility Criteria:
Inclusion Criteria:
* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
* Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
* Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: \[a\] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed \[b\] for patients with PSA \< 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan)
* Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography \[PET\]/CT) is strongly recommended
* Karnofsky performance score (KPS) \>= 70
* Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria:
* Patients with any evidence of distant metastases
* Patients with pathologically-confirmed N1 prostate cancer
* Patients with neuroendocrine or small cell carcinoma of the prostate
* Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03541850
Study Brief:
Protocol Section:
NCT03541850