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:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT02302105
Eligibility Criteria:
Inclusion
1. Any age according to the fitness estimated by the Physician
2. Physician estimated life expectancy \> 5 years
3. Biopsy proven Adenocarcinoma of prostate
4. High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + \[(GS - 6) x 10\] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA \> 15, T1-T3a N0 M0 If Gleason Score 6 - PSA \> 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
5. Ability to receive long term hormone therapy/ Orchidectomy
6. KPS ≥ 70 (see appendix)
7. Estimated life expectancy \> 5 years
8. No previous history of malignancy ≤5 years
9. No prior history of therapeutic irradiation to pelvis
10. Patient willing and reliable for follow-up and QOL
11. No major co morbidities preventing radical treatment
12. Signed study specific consent form
Exclusion
1. Any histopathology other than Adenocarcinoma
2. Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
3. No prior history of pelvic surgery
4. Uncontrolled diabetes
5. Uncontrolled cardiac co morbidity
6. Presence of nodal or distant metastatic disease
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02302105
Study Brief:
Protocol Section:
NCT02302105