Phase 3
Completed N=790
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT00309985 ↗Enrolled (actual)
790
Serious AEs
16.4%
Results posted
Mar 2016
Primary outcomePrimary: Overall Survival — 57.6; 44.0 months — p=0.0003
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
57.6; 44.0 | 0.0003 sig |
| SECONDARY Time to Clinical Progression |
33.0; 19.8 | <0.0001 sig |
| SECONDARY Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) |
20.2; 11.7 | <0.0001 sig |
| SECONDARY Proportion of Patients With PSA Complete Response (CR) at 6 Months |
0.320; 0.196 | <0.0001 sig |
| SECONDARY Proportion of Patients With PSA Complete Response (CR) at 12 Months |
0.277; 0.168 | <0.0001 sig |
| SECONDARY QOL Change From Baseline to 3 Months |
-2.7; -1.1 | 0.0009 sig |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed prostate cancer
- Metastatic disease
- On androgen-deprivation therapy for grade 1
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- Active cardiac disease, including the following:
- Active angina
- Symptomatic congestive heart failure
- Myocardial infarction within the past 6 months
- Prior chemotherapy in adjuvant or neoadjuvant setting
- Prior hormone therapy in the metastatic setting
- Concurrent 5-alpha reductase inhibitors
- Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202
Data sourced from ClinicalTrials.gov (NCT00309985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.