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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01008969
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age ≥ 18 years
* Diagnosis of definitive high-risk prostate cancer
* Clinically eligible and scheduled for definitive IMRT treatment with pelvic lymph nodal radiation (not a study procedure)
* At least one of the following risk factors:
1. Pathologically confirmed pelvic nodal involvement;
2. Enlarged pelvic lymph nodes (greater than 1 cm in the short axis) visible on CT or MRI images, or
3. Greater than 15% risk of lymph node involvement calculated using the equation: Risk of positive nodes (%) = (2/3) prostate specific antigen (PSA) + \[(Gleason score - 6)\] × 10\]. This formula is used to estimate the pathologic stage of prostate cancer with preoperative prostate specific antigen (PSA) and Gleason score, and adopted by many radiation oncology clinics, including our own radiation oncology physicians.
* Ability to give written informed consent and willingness to comply with the requirements of the protocol
Exclusion Criteria:
• Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01008969
Study Brief:
Protocol Section:
NCT01008969