title: A pilot study of quality of life of patients with hormone-refractory prostate cancer after gene therapy.
abstract: BACKGROUND
  The effects on quality of life (QOL) after a Phase I/II clinical trial of a combination of osteocalcin promoter-driven herpes simplex virus thymidine kinase (Ad-OC-TK) gene therapy and valacyclovir (VAL) were investigated for patients with hormone-refractory prostate cancer (HRPC).
  
  
  METHODS
  The QOL of six patients was prospectively assessed after gene therapy on days 0, 14, and 28. A modified questionnaire was created based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire's prostate cancer-specific module (EORTC QLQ-PR25).
  
  
  RESULTS
  The scores of all items significantly improved along with the total score. Further, bodily pain was significantly reduced on day 28. Moreover, the rate of change in the serum prostate-specific antigen levels from day 0 to day 28 was significantly correlated with the rate of change in bodily pain.
  
  
  CONCLUSIONS
  In this clinical trial, Ad-OC-TK plus VAL treatment significantly improved the short-term QOL and bodily pain of patients with localized recurrence or bone metastases of HRPC.
authors.affiliation: Laboratory of Cell and Gene Therapy Institute for advanced Medical Sciences, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nisinomiya Hyogo 663-8501, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Terao
authors.forename: Toshiro
authors.initials: T
authors.lastname: Shirakawa
authors.forename: Bishnu
authors.initials: B
authors.lastname: Acharya
authors.forename: Masahiro
authors.initials: M
authors.lastname: Miyata
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hinata
authors.forename: Kazushi
authors.initials: K
authors.lastname: Tanaka
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takenaka
authors.forename: Isao
authors.initials: I
authors.lastname: Hara
authors.forename: Michio
authors.initials: M
authors.lastname: Naoe
authors.forename: Kohzo
authors.initials: K
authors.lastname: Fuji
authors.forename: Takatsugu
authors.initials: T
authors.lastname: Okegawa
authors.forename: Eiji
authors.initials: E
authors.lastname: Higashihara
authors.forename: Sadao
authors.initials: S
authors.lastname: Kamidono
authors.forename: Masato
authors.initials: M
authors.lastname: Fujisawa
authors.forename: Akinobu
authors.initials: A
authors.lastname: Gotoh
mesh_terms: D015316:Genetic Therapy; D006801:Humans; D008297:Male; D010146:Pain / Q000150:complications; D011471:Prostatic Neoplasms / Q000150:complications / Q000628:therapy*; D011788:Quality of Life