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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02177292
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, adenocarcinoma of the prostate
* T1-2N0M0 with risk of pelvic lymph nodes involvement \>25% by Roach formula \[(2/3xPSA) + (Gleason Score - 6)x10\], or any T3-4N0M0
* Karnofsky Performance Scale \> 70.
* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
* No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
* Patients must sign a study-specific consent form prior to registration.
* No evidence of distant metastases (Bone scanning)
Exclusion Criteria:
* Clinical or pathological evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate
* History of prior chemotherapy
* History of prior pelvic radiation therapy
* Children (age \< 18).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02177292
Study Brief:
Protocol Section:
NCT02177292