# Research Project 5: Risk Stratification in Localized Prostate Cancer using Biomarkers in Blood

> **NIH NIH P50** · SLOAN-KETTERING INST CAN RESEARCH · 2020 · $270,997

## Abstract

One of the primary clinical challenges in prostate cancer is the management of screen-detected, localized
disease. Recent years have seen a dramatic increase in “active surveillance” (conservative management) of
low-risk disease. A corollary has been increased attention to the algorithms used for risk stratification. Although
Gleason grade is strongly predictive of oncologic outcome, it is clear that, while some men with low Gleason
grade on biopsy do in fact harbor high-risk disease, many men with higher Gleason grade would not in fact
experience symptoms of prostate cancer during the natural course of their life even if left untreated. We have
shown that a statistical model based on a panel of kallikrein markers in blood – total PSA, free PSA, intact PSA
and human kallikrein 2 (hK2) – strongly predicts risk of high-grade (Gleason score ≥7) cancer on biopsy. The
panel has been validated in multiple studies involving close to 15,000 men. We have also demonstrated that
the panel is highly predictive of the long-term risk of distant metastasis in men followed for many years without
screening. We propose to evaluate whether the clinical role of the panel could expand from decisions about
diagnostic biopsy to those concerning immediate treatment decision-making and active surveillance protocols.
We will first use data from five independent cohorts, three from Europe and two from the US, to determine
whether the panel of four kallikrein markers can predict either unfavorable pathology at radical prostatectomy
or post-treatment oncologic outcomes such as metastases. If so, the panel – data from which may often be
available from the diagnostic biopsy – could be used to help decisions about treatment versus conservative
management. Our second aim is to determine whether the panel of markers can predict the result of active
surveillance biopsy. If so, using the panel to avoid biopsy in men at low risk of progression would decrease the
number of biopsies required by active surveillance protocols, reducing morbidity and potentially increasing the
acceptability of active surveillance as a management strategy. We also aim to determine whether the
properties of the panel could be improved by either adding a novel marker, microseminoprotein-β (MSMB) or
modifying measured marker levels in the light of marker-related single-nucleotide polymorphisms (SNPs.)

## Key facts

- **NIH application ID:** 9998864
- **Project number:** 5P50CA092629-20
- **Recipient organization:** SLOAN-KETTERING INST CAN RESEARCH
- **Principal Investigator:** Hans Gösta Lilja
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $270,997
- **Award type:** 5
- **Project period:** 2001-09-14 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9998864

## Citation

> US National Institutes of Health, RePORTER application 9998864, Research Project 5: Risk Stratification in Localized Prostate Cancer using Biomarkers in Blood (5P50CA092629-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9998864. Licensed CC0.

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