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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT00996502
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative therapy.
* Evidence of progressive metastatic disease.
* Surgically or medically castrated. Patients must continue on medical castration (LHRH agonists) throughout protocol participation. Patients who have discontinued LHRH agonists should be restarted on therapy. Testosterone levels should be obtained prior to protocol initiation and should be less than 50 ng/mL.
* Previous antiandrogen and hormonal therapies must have been discontinued prior to protocol initiation.
* Receiving bisphosphonate therapies should have had this therapy started at least 4 weeks prior to treatment initiation and should be on a stable dose. Although being on bisphosphonate therapy is not an exclusion to the study, bisphosphonate therapy should not be started during the study.
* Fully recovered and greater than 4 weeks from any major surgery or radiation therapy. There must be greater than 8 weeks from last dose of radionucleotide administration. There must be greater than 7 days from minor surgical procedures (eg portacath insertion, fine needle aspirations or core biopsies).
* No previous cytotoxic therapy including estramustine or suramin. No previous therapies with anti-angiogenic agents including thalidomide or bevacizumab.
* No history of brain metastases.
* No current congestive heart failure (defined as New York Heart Association Class II, III, or IV).
* Well-controlled blood pressure. Those with a history of hypertension should be well-controlled on a regimen of anti-hypertensive medication (exclude if BP\>150/100).
* No history of significant bleeding (e.g. upper or lower gastrointestinal bleeding or hemoptysis) within 6 months of protocol enrollment.
* No history of gastrointestinal perforation, intraabdominal fistula, or intraabdominal abscess within 6 months of protocol enrollment.
* No history of arterial thrombotic events within 6 months of protocol enrollment.
* No active serious non-healing wound, ulcer, or bone fracture.
* Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1.
* \> 18 years old.
* Adequate hematopoietic and organ function.
* Able to swallow capsules.
* Willing to use effective means of contraception for study duration and for at least 3 months after the completion of protocol therapy.
* Able to provide informed consent.
Exclusion Criteria:
* Active second malignancy other than basal or squamous skin cancer. Patients who have completed all necessary therapy and are considered to have less than a 30% risk of relapse by their physician are not thought to have an active second malignancy.
* Serious concurrent uncontrolled medical disorder.
* Disease for whom corticosteroids are contraindicated such as an active peptic ulcer or uncontrolled diabetes. Patients with controlled diabetes may be considered but must be made aware that their diabetic medications may require adjustment.
* Received prior treatment with a tyrosine kinase inhibitor, estimated glomerular filtration rate inhibitor (EGFR), or vascular endothelial growth factor (VEGF) inhibitor. For the phase II trial, patients who have had previous cytotoxic therapy will not be eligible.
* Currently or have recently participated in a clinical trial (within 4 weeks from the first day of treatment) or are receiving investigational therapies.
* Unable to comply with study or follow-up procedures.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00996502
Study Brief:
Protocol Section:
NCT00996502