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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00924469
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements
* At least one of the following features: prostate specific antigen (PSA) greater than (\>) 10 nanogram per milliliter (ng/ml); PSA velocity \>2 ng/ml per /year (defined as a rise in PSA of \>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\>=) 7 (4+3); Gleason score 6 if either PSA \>=10 ng/ml or PSA velocity \>=2 ng/ml/year
* Serum testosterone \>200 nanogram/deciliter
* Participant and urologist must agree that participant is suitable for prostatectomy
Exclusion Criteria:
* Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection
* Abnormal liver function consisting of any of the following: serum bilirubin \>= 1.5 \* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \>=2.5 \* ULN
* Uncontrolled hypertension within the Screening period (systolic blood pressure \>= 160 millimeter of mercury \[mmHg\] or diastolic BP \>= 95 mmHg)
* Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily
* Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00924469
Study Brief:
Protocol Section:
NCT00924469