The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397).
OBJECTIVE
To explore patients' quality of life (QoL) during neoadjuvant hormone therapy (HT) using data from the Medical Research Council RT01 trial of standard- (64 Gy/32-fraction) and high- (74 Gy/37-fraction) dose radiotherapy (RT, both given conformally).


METHODS
Of the 843 patients randomized to the RT01 trial, 316 completed the Functional Assessment Of Cancer Therapy core questionnaire with its additional prostate subscale, and the Short Form-36 Health Survey questionnaire with the University of California-Los Angeles Prostate Cancer Index before HT and again before starting RT. Three predefined QoL hypotheses were generated to focus the analyses.


RESULTS
For the three primary QoL analyses there was evidence that sexual functioning deteriorated, urinary function did not change, and there was a slight decline in physical well-being after > or = 3 months of HT. Sensitivity analyses confirmed these findings. Exploratory analyses also suggested that role functioning deteriorated, sleep was more disturbed, and there was an increase in fatigue. However, overall QoL was not reported to be affected and patients indicated an improvement in attitude and satisfaction with treatment.


CONCLUSIONS
In this group of men, many of whom reported reduced sexual functioning before treatment, the additional decline during HT seemed to be generally accepted as the price to pay for an appropriate cancer treatment. Nevertheless, these changes need to be discussed with patients before HT is commenced.
Stephens
Richard J
RJ
Cancer Group, MRC Clinical Trials Unit, London, UK. rs@ctu.mrc.ac.uk
Dearnaley
David P
DP
Cowan
Richard
R
Sydes
Matthew
M
Naylor
Sharon
S
Fallowfield
Lesley
L
D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D001294:Attitude to Health; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects* / Q000523:psychology; D017060:Patient Satisfaction; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000523:psychology / Q000532:radiotherapy; D011788:Quality of Life; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal