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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT00071968
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Diagnosis based on a minimum of 6 core biopsy samples
* Clinically confirmed organ-confined disease
* Candidate for radical prostatectomy
* No evidence of metastatic disease by CT scan and bone scan
* High risk of relapse based on either of the following criteria:
* Any one of the following:
* Stage T2C or higher
* Gleason score greater than 7
* Prostate-specific antigen (PSA) greater than 20 ng/mL OR
* Any two of the following:
* Gleason score at least 7
* PSA 10-20 ng/mL
* Greater than 50% of total biopsy cores with cancer involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* No active bleeding
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* No acute or chronic hepatitis B
* Hepatitis B surface antigen negative
* No acute or chronic hepatitis C
* No antibodies to hepatitis C
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN
Renal
* No ongoing urinary tract infection necessitating rapid or emergent surgical resection
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No unstable angina
* No myocardial infarction within the past 6 months
* No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
Pulmonary
* No known pulmonary hypertension
* No pneumonitis
Other
* Fertile patients must use effective contraception during and for 12 weeks after study participation
* HIV negative
* No other severe immunocompromised states
* No active infection requiring antibiotic therapy
* No serious concurrent illness
* No other major illness that would substantially increase the risk associated with study participation
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* More than 3 weeks since prior IV corticosteroids
* No concurrent systemic corticosteroids
* No prior or concurrent hormonal therapy for underlying malignancy
Radiotherapy
* No prior or concurrent radiotherapy
Surgery
* More than 3 months since prior major surgery
Other
* More than 1 month since prior experimental drugs
* More than 3 weeks since prior immunosuppressive agents
* No concurrent immunosuppressive therapies
* No other concurrent investigational agents
* No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
* No concurrent ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, pimozide, or Hypericum perforatum (St. John's wort)
* No concurrent grapefruit or grapefruit juice
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00071968
Study Brief:
Protocol Section:
NCT00071968