A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial.
OBJECTIVE
To assess testosterone and haemoglobin kinetics in the Postoperative Adjuvant Androgen Deprivation (PAAD) trial, and correlate these with quality of life (QoL) in this prospective randomized study.


METHODS
Forty-three patients met the criteria for high-risk cancer after RRP (Gleason score > or = 8, pT3c or Gleason score 7 concomitant with pT3a/b and positive surgical margins) and were prospectively randomized to either observation or AD for 12 months. Haemoglobin and testosterone levels were determined and QoL surveyed at regular intervals for 24 months.


RESULTS
Serum testosterone levels were castrate in 19 of 21 treated patients at 3 months and all at 6 months after starting AD. Levels failed to return to normal at 6 months after stopping treatment in six of 16 (38%) patients, and at 12 months in three of 17 (18%). AD caused a delay in the recovery of haemoglobin levels to normal after RRP. There was no statistically significant decline in the Short Form-36 QoL score with AD. Scores on the University of California-Los Angeles Sexual Functioning Scale were decreased during AD, but returned to a level not statistically significantly different from controls after stopping treatment.


CONCLUSIONS
A year of adjuvant AD after RRP affected serum haemoglobin, testosterone and sexual function reversibly, with return to control levels within the subsequent year in most patients. No significant effect on overall QoL with AD was detected in the study.
Black
Peter C
PC
Deparment of Urology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
Basen-Engquist
Karen
K
Wang
Xuemei
X
Swartz
Richard J
RJ
Eddings
Teresa
T
Matin
Surena F
SF
Swanson
David
D
Wood
Christopher G
CG
Pisters
Louis L
LL
Babaian
Richard J
RJ
Troncoso
Patricia
P
Pettaway
Curtis A
CA
D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000379:methods; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011788:Quality of Life; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced*; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000097:blood*; D016896:Treatment Outcome
D000726:Androgen Antagonists; D006454:Hemoglobins; D013739:Testosterone; D017430:Prostate-Specific Antigen