Purpose of review
Prognostic clinical, pathological, and molecular parameters identify patients with nonmetastatic prostate cancer that are at risk for the development of future metastatic disease and shorter survival. In metastatic castration-resistant prostate cancer, docetaxel-based chemotherapy prolongs survival and improves quality of life, and is the standard of care. It may be rational to hypothesize that early utilization of chemotherapy may delay the onset of distant metastasis and prolong survival in the earlier nonmetastatic disease. A discussion on ongoing clinical trials and natural history aspects applicable to clinical trials design in this setting are presented herein.
Preliminary data suggest that chemotherapy is well tolerated, feasible, and potentially active in nonmetastatic prostate cancer. However, results from prospective randomized trials were not published yet.
In nonmetastatic prostate cancer, application of chemotherapy remains an open question awaiting prospective validation and should be routinely applied outside of clinical trials. In view of the long natural history, evaluation of conventional endpoints as time to distant metastasis and survival are challenging even in the high-risk patients. Appropriate patient selection based on predictive biomarkers and surrogate endpoints may provide critical information for patient selection and study design.