title: Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Hematology & Medical Oncology, OHSU Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA. beert@ohsu.edu
authors.forename: Tomasz M
authors.initials: TM
authors.lastname: Beer
authors.forename: Paul F
authors.initials: PF
authors.lastname: Schellhammer
authors.forename: John M
authors.initials: JM
authors.lastname: Corman
authors.forename: L Michael
authors.initials: LM
authors.lastname: Glodé
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Hall
authors.forename: James B
authors.initials: JB
authors.lastname: Whitmore
authors.forename: Mark W
authors.initials: MW
authors.lastname: Frohlich
authors.forename: David F
authors.initials: DF
authors.lastname: Penson
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D019496:Cancer Vaccines / Q000008:administration & dosage*; D004311:Double-Blind Method; D005221:Fatigue / Q000139:chemically induced*; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced; D011795:Surveys and Questionnaires; D013546:Sweating / Q000187:drug effects; D014020:Tissue Extracts / Q000008:administration & dosage*
chemical_list: D000726:Androgen Antagonists; D019496:Cancer Vaccines; D014020:Tissue Extracts; D007987:Gonadotropin-Releasing Hormone; C511774:sipuleucel-T