Prostate cancer is the most commonly diagnosed cancer accounting for approximately 60,000 new cases every year in Germany. However, it is only the third common cause of death from cancer. The widespread use of PSA as screening method for prostate cancer has led to an increased incidence of prostate cancer which is accompanied by a shift towards earlier stages of detected cancers. With respect to the demographic changes in industrialized countries the incidence of prostate cancer will continue to increase.
In the PROBASE study (Risk-adapted prostate cancer early detection study based on a “baseline” PSA value in young men – a prospective multicenter randomized trial) a modern concept of a general PSA-Screening will be investigated. However, the optimal age to begin a risk-adapted PSA screening with screening intervals according to the level of the individual baseline PSA value has never been evaluated in a prospective randomized trial. The present trial is the first randomized trial to prospectively evaluate the concept of a baseline PSA. Furthermore, it is the first trial to define the beginning of a risk-adapted screening either at age 45 or 50. In addition, this trial will evaluate subsequent risk-adapted screening intervals according to the level of the individual baseline PSA value.
Establishment of a national biobank for prostate cancer
Finally, repeated collection of body fluids (blood, urine) from the study subjects at each study visit as well as storage of tissue samples (prostate biopsies, biopsies of metastases, formalin-fixed paraffin embedded and fresh frozen tissue from radical prostatectomies) will allow prospective evaluation of molecular biomarkers in the diagnosis of prostate cancer. Early begin of sample collection – in most cases before initiation of prostate cancer – will give improved understanding of molecular pathomechanisms involved in initiation, progression, and clinical behavior of prostate cancer. Due to the high number of subjects within this trial and the repeated collection of samples the study will allow establishment of a large prostate cancer biobank in Germany.