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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT00242918
Eligibility Criteria:
Inclusion Criteria:
* prostate carcinoma: clinical stage T2b-3 or serum PSA\>20 ng/ml or Gleason sum score 8-10.
* clinical T2 patients are eligible if endorectal coil MRI shows T3 disease, or Gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required)
* ECOG performance status of 0, 1 or 2
* adequate hematological, liver and renal function
* existing peripheral neuropathy \< grade 1
* ability to tolerate oral medications.
Exclusion Criteria:
* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer
* any major surgery within four weeks
* prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00242918
Study Brief:
Protocol Section:
NCT00242918