CHICAGO—Prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life (QoL), according to study findings presented at the 47th Annual Meeting of the American Society of Clinical Oncology.
The study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University in Portland, involved men who were placed on ADT for three to four months after experiencing PSA recurrence following radical prostatectomy. Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, typically is not used in men with earlier stages of PCa. The study is the first to look at the effect of the autologous cellular immunotherapy on QoL.
Dr. Beer and his colleagues conducted a Phase 3 study of 176 men with PSA progression after radical prostatectomy. After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using various questionnaires, the researchers assessed QoL at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment. Ninety-eight percent of subjects completed baseline QoL assessment and 92% had at least one post-treatment assessment.
During ADT in the three months prior to sipuleucel-T treatment, QoL measures declined comparably in both study arms. Following initiation of study treatment, there were no significant differences found in QoL between the treatment groups.
“When you are starting therapies in advanced disease, the ability to extend life is more limited,” Dr. Beer told Renal & Urology News. “There is no definitive evidence that sipuleucel-T is beneficial in early disease, but the results from our study suggest that a larger study in early disease patients is needed.”