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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00027794
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Unilateral cT3a, cN0, M0
* Well or moderately differentiated tumor
* Gleason score no greater than 7 (4 plus 3 or 3 plus 4)
* Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)
PATIENT CHARACTERISTICS:
Age:
* 70 and under
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times normal
* ALT or AST less than 3 times normal
* PT and PTT normal
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* No myocardial infarction within the past 6 months
Pulmonary:
* No gross abnormalities on chest x-ray
Other:
* No other disease that would preclude surgery
* No other prior malignancy except adequately treated basal cell skin cancer
* No other concurrent primary malignancy
* No psychological, familial, sociological, or geographical condition that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging
Radiotherapy:
* No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity
Surgery:
* No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
70 Years
Study:
NCT00027794
Study Brief:
Protocol Section:
NCT00027794