Treatment of Localized Carcinoma of the Prostate (or How to Louse Up a 25 Million Euro Study)

DOI: 10.3238/zfa.2017.0410–0414

german translation / full article

Christiane Roloff, Lothar Weißbach

Keywords: prostate cancer PREFERE-study error analysis overtreatment active surveillance

Summary: The introduction of the PSA test for the early detection of prostate cancer (PCA) has led to an increasing incidence of localized disease. Although the discovery of metastasized tumors at first diagnosis is decreasing, that of localized tumors is steadily rising. Even though the latter requires only clinical observation, in practice the use of prompt surgical intervention or radiation therapy is common, and both are tantamount to overtreatment. Improved diagnostic procedures (PSA-test, randomized biopsy, multiparametric-magnetic resonance imaging [mp-MRI]) facilitate (but ever increase) the accurate diagnosis of low-risk PCA. The growing numbers of low-risk patients should be informed that active surveillance (AS) is an equivalent option to invasive therapy as to survival, and is a better alternative when considering adverse treatment effects. Starting in 2013, the randomized PREFERE study aimed to compare outcomes of available treatment options for low-risk PCA (radical prostatectomy [RP], external radiotherapy [RT], brachytherapy, and AS) all of which were being recommended as equivalent in the current German guidelines. This so called “worldwide largest clinical study for low-risk PCA” (DÄB 2013, 3) was terminated in December 2016. Though well-intentioned, PREFERE was doomed to fail for scientific, economical, ethical, and organizational reasons. Unfortunately, the available literature, discussed during the planning of the study, was neglected. Not all vicissitudes of oncology can be solved in the artificial environment of a randomized trial. A valuable lesson can be learned as a result of this exercise.`

(State: 16.10.2017)

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