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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT00020735
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Organ-confined (cT1-2) disease (stage I or II)
* Must be schedule to undergo radical prostatectomy
* Prior sextant biopsy required
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* ALT and AST less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
* No chronic hepatitis or cirrhosis
Renal:
* Creatinine less than 1.5 times ULN
Other:
* No severe mental or physical illness that would preclude radical prostatectomy
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* At least 5 years since prior antiestrogen, antiandrogen, LHRH agonist, estrogen, or progestational agent
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00020735
Study Brief:
Protocol Section:
NCT00020735