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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00790595
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate glad.
* Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
* Subjects defined as being at high risk for disease relapse based on the following criteria: PSA \> 10 ng/ml, and any one of the following: Gleason \> 7 or T stage \> T2b.
* Patients must have elected to and are a candidate to undergo a radical prostatectomy.
* Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
* Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.
* Performance status: ECOG \< 2.
* Life expectancy of at least 5 years.
* Absolute granulocyte count \> 1,500/mm3.
* Platelet count \> 100,000.
* Hemoglobin \> 9.0 g/dL.
* Serum calcium \< 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) \< 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT \< 5 x ULN if liver function abnormalities are due to underlying malignancy.
* Creatinine \< 1.5 ULN.
Exclusion Criteria:
* Patients who have stage T2a or less prostate cancer, Gleason \< 6, PSA \<10-ng/mL.
* Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
* Surgery within four weeks of study entry.
* Evidence of regional and/or distant metastases.
* Use of an investigational drug within 30 days prior to study entry.
* NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
* Any of the following thing the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade \> 2.
* Prolonged QTc interval on baseline EKG.
* Uncontrolled Hypertension (\>150/100 mm Hg despite optimal medical therapy).
* Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
* Known active infection.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00790595
Study Brief:
Protocol Section:
NCT00790595