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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00004050
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage II or III organ confined prostate cancer
* Resectable disease (candidate for retropubic prostatectomy)
* Gleason score at least 6
* Prostate specific antigen value (PSA) at least 5 ng/mL
* No significant central nervous system (CNS) disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 80-100%
* Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
* Not specified
Hematopoietic
* White blood cell count (WBC) greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9.0 g/dL
Hepatic
* Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal
* Prothrombin time (PT)/partial thromboplastin time (PTT) normal
* Albumin greater than 3.0 g/dL
* Hepatitis B surface antigen negative
Renal
* Creatinine normal
Cardiovascular
* No uncontrolled hypertension
* No significant cardiovascular disease
* No history of ventricular dysfunction or arrhythmia
* No congestive heart failure
* No symptoms of coronary artery disease
* No prior myocardial infarction
Other
* No active autoimmune disease
* No active infection requiring parenteral antibiotics
* HIV negative
* No significant psychiatric disorder that would preclude compliance
* No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer
* No diabetes mellitus
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for prostate cancer
* At least 5 years since other prior chemotherapy
Endocrine therapy
* No prior glucocorticoids for prostate cancer
* At least 5 years since other prior glucocorticoids
Radiotherapy
* No prior radiotherapy for prostate cancer
* At least 5 years since other prior radiotherapy
Surgery
* See Disease Characteristics
* At least 4 weeks since prior intrathoracic or intrabdominal surgery
* At least 2 weeks since other major surgery
Other
* At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents
* No other neoadjuvant or concurrent anticancer drugs
* No concurrent immunosuppressive drugs
* No other concurrent experimental therapy
* No concurrent parenteral antibiotics
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00004050
Study Brief:
Protocol Section:
NCT00004050