Risk of Recurrent Disease 6 Years After Open or Robotic-assisted Radical Prostatectomy in the Prospective Controlled Trial LAPPRO.

BACKGROUND

Conclusive evidence of superiority in oncological outcome for robot-assisted laparoscopic prostatectomy (RALP) over retropubic radical prostatectomy (RRP) is lacking.

OBJECTIVE

To compare RALP and RRP regarding recurrent disease and to report the mortality rate 6 yr after surgery.

DESIGN SETTING AND PARTICIPANTS

A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011 in Laparoscopic Prostatectomy Robot Open (LAPPRO)- a prospective, controlled, nonrandomized trial performed at 14 Swedish centers.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Data were collected at visits and by patient questionnaires at 3, 12, and 24 mo, and through a structured telephone interview at 6 yr. Cause of death was retrieved from the National Cause of Death Register in Sweden. The modified Poisson regression approach was used for analyses.

RESULTS AND LIMITATIONS

After adjustment for patient-, tumor-, and surgeon-related confounders, no statistically significant difference was observed between RALP and RRP in biochemical recurrence rate (14 vs 16%, relative risk [RR] 0.77, 95% confidence interval [CI] 0.56-1.06) or in not cured endpoint (22% vs 23%, RR 0.82, 95% CI 0.6-1.11). Stratified by D'Amico risk group, a significant benefit for RALP existed for recurrent disease in high-risk patients (RR 0.47, 95% CI 0.26-0.86,  = 0.02). All-cause mortality was 3% ( = 96). Prostate cancer-specific mortality was 0.6% ( = 21) overall, 0.3% ( = 8) after RALP, and 1.5% ( = 13) after RRP. The nonrandomized design is a limitation.

CONCLUSIONS

No significant difference was observed for cancer recurrence rate between RALP and RRP 6 yr after surgery. However, in a subgroup analysis, we found a significant benefit for RALP regarding recurrence rate in the high-risk group. Larger studies with longer follow-up are needed to make a firm conclusion and to evaluate a possible survival benefit.

PATIENT SUMMARY

In general, the oncological outcome is comparable between robotic and open radical prostatectomy 6 yr after surgery. For high-risk patients, our findings indicate that there is an advantage for robotics, but further studies with longer follow-up time is needed to make a firm conclusion.