Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients

A Single-Center, Retrospective, Blinded Validation Study to Investigate the Prognostic Value of the Prostatype Test System (PrTS) in Prostate Cancer Patients in China

Prostate Cancer is the most common type of cancer among men in many countries. However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. A substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. Moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (P-score), intended to measure gene expression levels of three biomarkers: IGFBP3, F3 and VGLL3. Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. This is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the Prostatype test system.

Inclusion Criteria:

• Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy
• Regular visits, treatment and laboratory tests were conducted in the past
• There is biopsy materials at the time of diagnosis (without staining FFPE)
• The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%
• Complete records of relevant clinical follow-up information

Exclusion Criteria:

• Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples
• Relevent clinical parameters of the patients are not available
• Treatment methods are not available
• Age of diagnosis < 50 years
• Age of diagnosis > 100 years
• Total tumor length < 2 mm
• The patient died of an accident, homicide or suicide