Despite bringing lower rates of positive surgical margins and lower PSA nadirs, long-term neoadjuvant hormonal therapy did not lead to a difference in rates of PSA recurrence after 7 years.
Chicago-Despite bringing lower rates of positive surgical margins and lower PSA nadirs, long-term neoadjuvant hormonal therapy did not lead to a difference in rates of PSA recurrence after 7 years, according to results of a study presented at the AUA annual meeting.
The randomized phase III trial looked at 7-year PSA relapse rates in 505 evaluable patients who had 3 versus 8 months of leuprolide and flutamide (Eulexin) before radical prostatectomy. PSA relapse was defined as two PSA elevations after surgery of greater than .4 μ/L. The PSA relapse rates were 33% in the 3-month group and 30% in the 8-month group, which was not a significant difference.
Even when analyzed by risk factors, including baseline PSA, Gleason score, and pathologic stage, the PSA relapse rates were still similar between groups. But the median PSA relapse rate was significantly lower (24%) in the 267 men who were enrolled at the three top-recruiting, high-volume sites compared with the rate (40%) in the 238 men enrolled at the eight low-volume sites.
The study "provides additional data that surgical technique is an important factor in controlling disease," he told Urology Times.
For all sites, overall survival was high at 93%. Disease-specific mortality rates were very low as well, Dr. Gleave said.
Does surgical volume matter?
The experience holds an important lesson for future studies.
"It highlights the need to stratify for site of surgery in future randomized, multimodal prostatectomy trials," Dr. Gleave said. "It also generates the interesting hypothesis that benefit of prolonged neoadjuvant therapy may exist when employed by more experienced or higher-volume surgeons."
The differences among sites hold lessons for practice, too.
"It's a very sensitive topic that we all have to look at our own results and evaluate positive margin rates and PSA recurrence accordingly," said Dr. Gleave. But the bottom line, he said, is that "off-protocol, neoadjuvant therapy is not indicated prior to surgery."
On protocol, he noted, "The field has moved on now to looking at more combination chemohormonal approaches."