A pilot study of quality of life of patients with hormone-refractory prostate cancer after gene therapy.
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.
Terao
Shuji
S
Laboratory of Cell and Gene Therapy Institute for advanced Medical Sciences, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nisinomiya Hyogo 663-8501, Japan.
Shirakawa
Toshiro
T
Acharya
Bishnu
B
Miyata
Masahiro
M
Hinata
Nobuyuki
N
Tanaka
Kazushi
K
Takenaka
Atsushi
A
Hara
Isao
I
Naoe
Michio
M
Fuji
Kohzo
K
Okegawa
Takatsugu
T
Higashihara
Eiji
E
Kamidono
Sadao
S
Fujisawa
Masato
M
Gotoh
Akinobu
A
D015316:Genetic Therapy; D006801:Humans; D008297:Male; D010146:Pain / Q000150:complications; D011471:Prostatic Neoplasms / Q000150:complications / Q000628:therapy*; D011788:Quality of Life