THE "NEW" PROSTATE CANCER INFOLINK

A new paper in the Scandinavian Journal of Urology and Nephrology has provided detailed information about the design and conduct of an ongoing, prospective, non-randomized trial comparing open radical retropubic prostatectomy (RRP) to robot-assisted laparoscopic radical prostatectomy (RALP) in treatment of localized prostate cancer.

Thorsteinsdottir et al. describe what appears to be a sophisticated and well-designed study that will be fully enrolled with more than 2,000 patients by October this year: the so-called LAPPRO study. The trial is intended to compare the two surgical techniques with regard to short- and long-term functional and oncological outcomes as well as cost effectiveness and quality of life.

Important factors in the design of this study include:

• Participation by 12 urology departments at hospitals in Sweden, all highly experienced in the conduct of radical prostatectomy
• The use of a prospective system to record symptoms experienced by patients through the use of four validated patient questionnaires
• Complete documentation of surgical details, clinical examinations, medical facts, and use of other resources through the use of six specially developed case report forms
• Urinary leakage 1 year after surgery as the primary study endpoint
• Erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery as the secondary endpoints
• A 2:1 study design, with 700 patients planned to have RRP and 1,400 to have RALP

We have noted previously that it was going to be very likely that this type of comparative evaluation of the effectiveness of differing methods for the treatment of localized prostate cancer would happen outside the U.S.A. rather than within it. As the authors themselves point out, ” The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable.”

Assuming that enrollment in this study is “on track,” we can probably expect to see some initial results from this study available at some time in 2013.

Filed under: Management, Treatment | Tagged: comparative, effectiveness, localized, open, RALP, robot-assisted, RRP, surgery |