A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life. These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.
The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy. Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer. This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.
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 survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment. Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment. During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms. After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.
Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.