National randomized study of chemotherapeutic agents in advanced prostatic carcinoma: a progress report.

In the 36 months since its inception, the National Prostatic Cancer Project treatment subgroup has randomly assigned over 360 patients with progressive advanced prostatic cancer who were no longer responsive to endocrine manipulation to either one of four different clinical studies. The initial study demonstrated a clear superiority for 5-fluorouracil (5-FU) and cyclophosphamide over continued conventional therapy. Beneficial responses were documented and are associated with increased survival rates and relief from pain and other symptoms. A proportionately larger number of patients obtained clinical benefit (stable and partial regression) on cyclophosphamide than on standard or 5-FU therapy. The criteria for evaluation of patients are supported by the survival data, ie, responders have survived for a longer period of time than those patients who continued in progression. Preliminary data from the subsequent protocols have documented a 30% response (stable and partial regression) in patients receiving oral estramustine phosphate and definite responses in patients treated with DTIC; Too few patients have been treated with Leo 1031 to offer total response rates at this time, although the early results are promising. These clinical studies have firmly established a place for chemotherapy in the management of prostatic cancer. New trials will introduce single- and multiple-drug chemotherapy at earlier phases of the clinical course of prostatic cancer patients.

RCT Entities:   Population Interventions Outcomes