Systemic therapy in men with metastatic castration-resistant prostate cancer / : EBS 3-15, version 2

The clinical trials registry of the National Institutes of Health (clinicaltrials.gov) was searched and relevant recently begun or ongoing trials are listed at the end of the document. [...] Of the studies included in the CRPC chapter, 27 did not meet our criteria, five were included in the original version of this guideline, and six were published since the original guideline. [...] Of these, one trial compared atrasentan, 10 mg with placebo in 809 men with mCRPC (24) in a follow-up of the study reported in a meeting abstract in the previous version of this guideline; one trial was a final safety and efficacy analysis of zibotentan, 10 or 15 mg, compared with placebo in 312 men (25); and one trial compared zibotentan, 10 mg/day with placebo in 594 men (27). [...] The publication of the SWOG 99-16 and TAX 327 trials established the effectiveness of docetaxel and prompted the refusal of clinicians to use prednisolone monotherapy in mCRPC patients. [...] The incidence of grade 3 or higher adverse events was 58% in the calcitriol group and 70% in the placebo group (39).