Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer.

Beer TM, Schellhammer PF, Corman JM, Glodé LM, Hall SJ, Whitmore JB, Frohlich MW, Penson DF
Urology. 2013 82 (2): 410-5

PMID: 23896100 · DOI:10.1016/j.urology.2013.04.049

OBJECTIVE - To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer.

METHODS - Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list.

RESULTS - One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P = .68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P = .88). Results were comparable for usual fatigue (P = .91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P = .26). The proportion of patients reporting better overall QOL on GRoC was similar (P = .62).

CONCLUSION - There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

Copyright © 2013 Elsevier Inc. All rights reserved.

MeSH Terms (17)

Aged Androgen Antagonists Antineoplastic Combined Chemotherapy Protocols Cancer Vaccines Double-Blind Method Fatigue Gonadotropin-Releasing Hormone Hot Flashes Humans Male Middle Aged Prostatic Neoplasms Quality of Life Sexual Dysfunction, Physiological Surveys and Questionnaires Sweating Tissue Extracts

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