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Until the recent positive findings from the STAMPEDE trial, Joseph F. Renzulli, II, MD, FACS, explains that he would have rather used hormonal therapy or radiation therapy in patients with untreated metastatic prostate cancer, as opposed to chemotherapy, based on GETUG AFU-15 trial, which found no significant benefit from upfront chemotherapy in node-positive disease.
In the phase III STAMPEDE trial, the addition of docetaxel to standard hormonal therapy significantly improved overall survival (OS) among men with newly diagnosed, hormone-naïve advanced prostate cancer. OS was approximately 77 months and 67 months for those receiving docetaxel with ADT versus ADT alone, respectively (HR = 0.76; P = .003).
While STAMPEDE may have paved the way for upfront chemotherapy in the metastatic prostate cancer population, there are challenges with this approach in those patients who are non-metastatic, explains Daniel P. Petrylak, MD. There is a delay in disease progression in these patients, but studies have not been powered well enough to show a survival benefit. Several ongoing trials may provide more confirmatory evidence as to whether using chemotherapy can actually result in a survival benefit, he notes.
The PUNCH trial is examining the use of docetaxel followed by radical prostatectomy versus radical prostatectomy alone. The TAX 3503 trial randomized patients who had failed prostatectomy who hda a rising PSA to 18 months of hormonal therapy plus docetaxel versus hormonal therapy alone. Although this trial has received minimal attention, according to Petrylak, it is crucial to this whole treatment schema because this is a commonly seen group of patients who may actually benefit from getting chemotherapy early. This approach may also delay the time to reinstitution of hormone therapy, he adds