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Proposal 997

Title of the Proposed Research

Predictors of Prostate Cancer Progression Among Men on Active Surveillance

Lead Researcher

Stephen Freedland, MD

Affiliation

Duke University
Durham, NC, US

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

27 May 2014

Lay Summary

Prostate cancer is the most common cancer in men, accounting for nearly 25% of all cancer diagnosed in males. However, multiple studies suggest localized prostate cancer is frequently overtreated despite the low risk of cancer-related mortality. Results from the Surveillance, Epidemiology, and End Results suggests that more than 75% of men with low-risk disease undergo aggressive local therapy. A population-based cohort study suggested a 10 year cancer-specific survival of 94% in men aged 65–74 years with conservatively managed stage T1 or T2 cancers at diagnosis.

Given the low morbidity and mortality of low-volume, low-grade localized prostate cancer, patients with very low-risk prostate cancer are now managed with active surveillance. Most active surveillance protocols include follow-up with repeat biopsies and switch to active treatment (radical prostatectomy, radiotherapy or androgen deprivation therapy) based on disease progression. A limited number of small studies investigated the predictors of disease progression in men undergoing active surveillance. Some of these studies showed that PSA levels and/or PSA kinetics alone do not accurately predict the risk of prostate cancer progression. However, the use of combined variables including demographics, biochemical and pathological variables, comorbidities and medication use to predict prostate cancer progression has not been evaluated in the setting of active surveillance.

The Objectives are:
1) Determine predictors of prostate cancer progression.
2) Creation of a predictive tool or nomogram to determine the risk of prostate cancer progression.

This will involve secondary statistical analysis of the data captured in the REDEEM trial (Nested cohort study) of 302 participants. We will define the variables most predictive of prostate cancer progression among patients with prostate cancer on active surveillance. In addition, we seek to explore the combination of variables including demographics such as age and body-mass index, PSA levels and kinetics, Gleason score, percent of positive biopsy cores, comorbidities and medication use to predict the risk of prostate cancer progression among these patients. The univariable predictors of prostate cancer progression will be tested using chi-square tests for categorical covariates and t-test for continuous variables.

This will result in a creation of a predictive tool or nomogram to determine the risk of prostate cancer progression at the time of entering the active surveillance protocol.

The results of this project will be published and will help patients and physicians better decide when and whether to start an active surveillance protocol or not. In addition, it may help individualize the follow-up scheme based on risk of prostate cancer progression, i.e. patients with higher risk of progression may receive more frequent biopsies whereas patients with very low risk of progression may undergo repeat biopsies less frequently.

Study Data Provided

Study AVO105948: A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men who are Candidates for or Undergoing Expectant Management

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation