Periodic Reporting for period 1 - BioGuidePCa (Biomarker Guided Prostate Cancer Management)
Reporting period: 2014-11-01 to 2015-04-30
In the context of the feasibility analysis we also performed a preliminary study, investigating the producibility of the mCRPC Progression Test as well as the PCa Status Test. For the evaluation of the concept of the mCRPC Pro-gression Test, a total of 10 mCRPC patients and 16 non-mCRPC diseased controls were obtained from the Urology Department of the Hannover Medical School. Primary classification of the samples with a previously reported General Cancer biomarker classifier resulted in poor differentiation between cases and controls (AUC = 0.744). Hence the available samples were divided in a training- and test-set in order to perform further statistical analysis targeting the development of a new more specific biomarker classifier. Classification with the newly established specific mCRPC biomarker pattern resulted in an AUC of 1.0. We therefore suggest that the biomarker should be further developed in a subsequent study, best funded in the framework of Phase 2. For the preliminary study of the PCa Status Test, seminal fluid samples were analysed. A total of three biomarker classifiers were developed to allow accurate classification of the tumour according to its Gleason Score and TNM Stage. For all classifiers AUC values > 0.84 were obtained, verifying the functionality of the test according to the defined clinical need. Since the results of the preliminary study are excellent, both diagnostics test should be developed to marketability in the framework of the PHC 12-2105-2 call of the Horizon 2020 program.
PCa mortality is typically attributed to the metastatic castration-resistant prostate cancer (mCRPC). Thus mCRPC represents the end stage of the disease. Historically the median survival for men with mCRPC has been less than two years. Although the disease is not curable, the quality of life can nowadays be improved by palliative therapy. Unfortunately successful therapy cannot be predictable as it depends on the molecular behaviour of the tumour. Hence incorrect drugs with not life prolonging effect are regularly applied. The mCRPC Progression test will be developed for patients that are either diagnosed biochemically or radiologically with CRPC at the beginning of treatment. The mCRPC Progression test will be able to detect early metastatic growth and predict disease progression, hence enabling advanced treatment decision-making. By using the mCRPC Progression test early treatment failure could be detected, guiding thus the doctor and the patient for treatment adjustment. The mCRPC progression test is non-invasive. Urine is easily accessible and has no physical side effects for the patient. The aforementioned biomarker panel will permit an individual as well as a small-meshed monitoring during treatment.