Prostate cancer (PCa) is the second most common cancer in men, with an estimated 1.1 million new cases and 307,000 deaths in 2012 (Globocan 2012). Limitations in the current clinical tools for management of PCa have resulted in over-diagnosis and costly over-treatment which is affecting the outcomes and quality of life of men. This has led to great focus among the biotech industry on developing biomarkers that are able to improve the clinical decision-making process, with particular interest in accurate, noninvasive, and practical tests.
Scientists at the University of Oslo have identified a novel blood based protein biomarker, LRG1, which is posed to greatly improve clinical management of prostate cancer. The biomarker has been validated in multiple clinical cohorts and pre-treatment measurement of serum biomarker levels demonstrates the following utilities: Predicts risk of metastasis (p=0.002) Improves risk assessment when added to current clinical criteria (p=0.033) Predicts disease recurrence after surgery (p=0.043) and radiotherapy (p=0.012) Predicts the benefit of radiotherapy in addition to hormone therapy (p=0.024) Based on these properties, we propose that the biomarker should be implemented after definite diagnosis, to help improve patient risk stratification and, furthermore, to help select the appropriate treatment for high risk patients. The initial target population for a test based on the biomarker is envisioned to be patients currently indicated for primary surgery, and whose post-surgery pathology evaluations do not identify any high-risk factors necessitating administration of adjuvant radiotherapy (estimated 80% of surgery cases). A positive result from a pre-surgical test, indicating high risk of recurrence, would indicate the need for adjuvant therapy. The biomarker is currently undergoing further clinical validation for the primary clinical utility.
The invention is protected by a published patent application ( WO 2016110782A1 ).