Worldwide about 1.3 million new cases are diagnosed every year. While the majority of the patients are diagnosed with indolent tumors with low risk for progression, about 25% will develop progression and eventually die from their disease. Current diagnostic and prognostic tests are too unspecific to predict this clinical variation, leading to overtreatment in many cases but also missed opportunities for a cure and/or improved survival in others. Thus, the native market for improved risk assessment at diagnosis involves about 75% of cases, while 25% need better treatment stratification due to metastatic disease.
A tool for improved risk assessment in PC patients at diagnosis will be developed, to guide clinicians when stratifying patients with indolent tumors into no treatment intervention and patients with progressive disease into active treatment. The tool will build upon digital evaluation of prostate biopsy sections immunohistochemically stained for the prognostic markers Ki67 (tumor cell proliferation rate) and PSA (tumor cell differentiation). The Ki67/PSA will be combined with conventional risk markers into a model calculating the risk for PC death within 10 years if the cancer is left untreated. With an adjusted model, the tool will also be used also to estimate the risk for disease progression after androgen-deprivation therapy of patients with metastatic PC, and thus to identify patients in need of complementary therapies upfront.
Benefits of the invention:
- The invention is easily implemented as part of clinical routines.
- Patients with indolent tumors will be left untreated and spared unnecessary side-effects such as impotence, incontinence, bowel symptoms, etc.
- Patients with aggressive PC will receive efficient treatment at an early stage.
- Patient survival will increase.
- Health care costs will be reduced by avoiding unnecessary treatment of low-risk patients and of patients who will not benefit from add-on treatments.Competing products exist but at present, they are not included or recommended as standard management of PC in Sweden.