The diagnostic and treatment approaches for oPCa and yhPCa vary greatly even between large centers in Germany, which explains the lack of meaningful prospective data. There are no uniform evidence-based treatment recommendations in the guidelines for these patients. The current PiR-hoP project aims to use structured data to gain insights into the use of diagnostic and therapeutic approaches for oPCa or yhPCa in the six university cancer centers in Bavaria. In addition, a cross-site prostate cancer register, including structured documentation of the diagnostics and therapy used in both patient groups, will help to develop and conduct clinical studies based on real-world data.

The main objective is to establish a cross-site prospective clinical registry for the two specific groups of prostate cancer patients who present a particular clinical challenge (oPCa; yhPCa). Since only relatively few of these patients are treated in each center, the network of university centers in Bavaria offers a great opportunity to derive relevant conclusions from aggregated data on these patients through cross-site studies. The structure of the database should be designed from the outset in such a way that it can be expanded over time with specific modules. The clinical registry to be set up should help to answer questions about the real care situation of patients from these two complex patient groups and, as a research database, support biomarker studies, other prospective IITs and industry-sponsored clinical studies.

The project to develop a cross-site prostate cancer registry is divided into six work packages (WP). Each work package will be worked on by different experts from the six Bavarian university sites, which will ensure close networking between the sites. The tasks in all work packages will be carried out in parallel with the joint efforts of the BZKF to harmonize the exchange of clinical data and imaging between the centers and will be adapted accordingly

WP 1: Evaluation of the different EDC systems used at the BZKF sites (1-3 months)

WP 2: Definition of a standardized clinical data set including the ADT-GEKID core data set and extended parameters (1-6 months)

WP 3: Definition of a patient consent form as an extension of the MII template for broad consent and its roll-out (1-12 months)

WP 4: Definition of the requirements for the most suitable EDC system (7-9 months)

WP 5: Development of a standardized reporting system for innovative imaging procedures such as MRI and PET/CT (7-18 months)

WP 6: Programming the database and carrying out iterative tests (7-18 months)