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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT00349557
Eligibility Criteria:
Inclusion Criteria:
* High Risk Prostate Cancer as defined as ONE of the following:
1. Clinical T2b-T4
2. Gleason sum score 8-10
3. PSA more than 20 and Gleason sum score 7
4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
* No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
* ECOG performance status of 0, 1 or 2
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)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Presence of central nervous system or brain metastases
* Blood pressure of \>150/100 mmHg
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00349557
Study Brief:
Protocol Section:
NCT00349557