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

Abstract

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. PATIENTS AND METHODS Forty‐three patients met the criteria for high‐risk cancer after RRP (Gleason score ≥ 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. CONCLUSION 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.

Health Related Quality of Life in Patients Treated With Multimodal Therapy for Prostate Cancer

“…11 Black et al likewise found that in patients receiving RP adjuvant ADT resulted in only a transient worsening of sexual function. 10 Thus, when ADT is given as adjunctive therapy to BT or EBRT, there is a transient decrease in sexual function that appears to be short-lived. However, in patients with baseline high sexual function scores undergoing RP or BT the HRQOL effects of ADT may be more pronounced and prolonged.…”

Long-term quality of life after radical prostatectomy in wives of men in the postoperative adjuvant androgen deprivation trial

“…Trial participants were at high risk for cancer recurrence based on tumor stage, Gleason score, and surgical margin status [6]. This risk was consistent with a projected 5-year disease free survival rate of approximately 65% or less [15–17].…”

“…After completing radical retropubic prostatectomy at MD Anderson Cancer Center, men at high risk for recurrence were invited to participate in the Postoperative Adjuvant Androgen Deprivation Trial testing 5-year clinical outcomes in men receiving 1 year of androgen deprivation versus observation [6]. Married men in this trial and their spouses were invited to enroll in a companion study to examine quality of life.…”

“…Women’s husbands were randomized to the observation (56%) and androgen deprivation (44%) groups. Additional details about men’s clinical status and quality of life are published elsewhere [6]. …”

“…Men who have androgen deprivation therapy experience fatigue, hot flashes, and sexual side effects [5]. Treatment for men at high risk of recurrence remains controversial so trials are underway comparing survival and quality of life (e.g., [6]) for different treatments.…”