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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT00776594
Eligibility Criteria:
Inclusion Criteria:
* History of biopsy documented prostate cancer (any Gleason score)
* Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
* If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
* PSA recurrence with PSAdt \< 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
* No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
* Prior ADT allowed if \< 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
* ECOG Performance status of 0-1
* Absolute neutrophil count of \>1,500
* Platelet count \> 100,000
* Hg \> 8g/dl
* No history of bleeding or thromboses within the last 12 months that required medical intervention
Exclusion Criteria:
* History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
* Medical condition requiring concomitant corticosteroids
* Active infection
* Prior chemotherapy allowed if was \< 6 cycles and \> 6 months prior to study entry
* Documented local recurrence or metastatic prostate cancer
* Inability to comply with study and/or follow-up procedures
* Life expectancy of less than 2 years
* 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:
NCT00776594
Study Brief:
Protocol Section:
NCT00776594