At a glance
ClinicalIndex Comparison Record- ✓Histologically documented adenocarcinoma of the prostate with clinically metastatic disease (bone, CT, or MRI) despite castrate testosterone levels (maintained via orchiectomy or LHRH agonist)
- ✓Progressive metastatic disease, either measurable (≥20 mm conventional or ≥10 mm CT/MRI) with any PSA level, or non-measurable with PSA ≥5 ng/mL
- ✓Documented progressive disease since most recent therapy change (measurable disease >20% increase, bone scan progression, or PSA progression)
- ✓Progression despite standard androgen deprivation therapy (LHRH agonist and/or orchiectomy)
- ✕Prior cytotoxic chemotherapy, estramustine, or suramin
- ✕Prior anti-angiogenesis agents including thalidomide or bevacizumab
- ✕Known brain metastases
- ✕Current congestive heart failure (NYHA Class II, III, or IV)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Doctaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) in Men With Hormone Refractory Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating docetaxel, placebo, and 3 other interventions for Adenocarcinoma of the Prostate and 3 related conditions. Completed, enrolled 1,050 participants across 2 sites.
Detailed Summary
This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Given orally
Given IV
Correlative studies