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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02446366
Eligibility Criteria:
Inclusion Criteria:
* Adenocarcinoma of the prostate treated primarily with radical prostatectomy
* Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy
* One of the following pathologic classifications
* T3N0 disease with or without a positive surgical margin or
* T2N0 disease with or without a positive surgical margin
* Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or
* Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
* Zubrod performance status of 0 -1
* No distant metastases, based on the following workup within 60 days prior to registration
* Magnetic resonance imaging (MRI) of the pelvis
* Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis
* Patients can be on androgen deprivation therapy
* Ability to understand and willingness to sign a study-specific informed consent prior to study entry
Exclusion Criteria:
* N1 patients are ineligible, as are those with lymph node (LN) enlargement \> 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative
* Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
* Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
* Prior radiation of any kind to the prostate gland or pelvis
* Prior brachytherapy is not allowed
* History of inflammatory colitis or other active severe comorbidities
* Patients who are on immunosuppressant medication
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02446366
Study Brief:
Protocol Section:
NCT02446366