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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00528866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Pathologically proven adenocarcinoma of the prostate gland meeting one of the following criteria:
* Gleason ≥ 7and post-operative PSA nadir \> 0.2 ng/ml with any pathologic tumor (pT) classification
* Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification
* Must have undergone radical prostatectomy within the past year
* PSA must be obtained within 6 weeks (42 days) prior to study registration
* No lymph node or distant metastases (N0, M0), based upon the following minimum diagnostic workup:
* History and physical examination within 8 weeks prior to study registration
* Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on bone scan within 16 weeks prior to study registration
* No pelvic lymph nodes \> 1.5 cm in greatest dimension on CT scan or MRI of the pelvis within 16 weeks prior to study registration, unless the enlarged lymph node is biopsied and negative
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Absolute neutrophil count (ANC) ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Total bilirubin ≤ 1.2 times ULN
* No other invasive malignancy within the past 3 years except non-melanomatous skin cancer
* No active, severe co-morbidity, including any of the following:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
* AIDS
* HIV testing is not required for study entry
* No prior allergic reaction to the study drug(s)
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy for prostate cancer
* More than 3 years since prior chemotherapy for a different cancer
* No prior androgen deprivation for treatment of prostate cancer
* Prior use of hormonal agents, such as finasteride or dutasteride, for treatment of benign prostatic hypertrophy is allowed
* No prior radiotherapy to the region of the prostate that would result in overlap of radiotherapy fields
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00528866
Study Brief:
Protocol Section:
NCT00528866