At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate with Stage IV disease and bone metastases evidence
- ✓Hormone-refractory disease defined by PSA progression (≥3 consecutive rising PSA levels ≥1 week apart, PSA ≥5 ng/mL) OR measurable/nonmeasurable disease progression
- ✓Prior surgical or medical castration with continuation of LHRH agonist or antagonist during study
- ✓Age ≥18 years
- ✕Prior cytotoxic chemotherapy for metastatic prostate cancer
- ✕Brain metastases (prior or concurrent)
- ✕Symptomatic pleural effusion or third space fluid accumulation (ascites)
- ✕Symptomatic sensory neuropathy ≥grade 2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating atrasentan hydrochloride, docetaxel, and 2 other interventions for Metastatic Cancer and Prostate Cancer. Completed, enrolled 1,038 participants across 554 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
Study Details
Timeline
Interventions
Given orally
Docetaxel given IV and prednisone given orally
Docetaxel given IV and prednisone given orally
Given orally