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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00672594
Eligibility Criteria:
Inclusion Criteria:
* Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
* Intermediate or high risk, clinically localized disease
* Adequate organ function
* Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
* Select imaging to rule out metastasis will be done as clinically indicated
* Signed and date informed consent document
Exclusion Criteria:
* Prior treatment for prostate cancer
* Major surgery or radiation therapy within 4 weeks of starting the study treatment
* NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
* History of or known metastatic prostate cancer
* Any of the following within the 6 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 grade 2 or greater
* QTc interval \> 500 msec on baseline EKG
* Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy).
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Known active infection
* Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00672594
Study Brief:
Protocol Section:
NCT00672594