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Proposal 1013

Title of the Proposed Research

Biopsy Avoidance in Patients At Risk For Prostate Cancer and in Patients With Low Risk Prostate Cancer: Developing Tools for Personalized Medicine

Lead Researcher

Girish Kilkarni, MD, PhD

Affiliation

Princess Margaret Cancer Centre
University Health Network
Toronto, Ontario
CA

Funding Source

Grants from Prostate Cancer Canada (PCC) and the Canadian Urological Association Scholarship Fund (CUASF) are funding this investigation.

Potential Conflicts of Interest

None

Data Sharing Agreement Date

16 June 2014

Lay Summary

Prostate cancer (PCa) is the most commonly diagnosed cancer among Canadian men. In the modern Prostate Specific Antigen (PSA)-screening era, there has been an increase in the detection of patients with low risk disease.(1, 2) A substantial majority of these men will die from causes other than prostate cancer, pointing to the indolent nature of many screen-detected prostate cancers.(3)

Until recently, patients diagnosed with low risk prostate cancer were treated aggressively with radical surgery or radiation. Radical treatment, however, is associated with significant morbidity including sexual dysfunction, incontinence, voiding dysfunction and rectal toxicity.(4) These data, along with an increasing appreciation of the less than aggressive nature of many prostate cancers, have prompted active surveillance (AS) regimens for low risk prostate cancer. Patients on AS are followed closely with PSA tests, digital rectal examinations (DRE) and frequent (1-2 year interval) prostate biopsies to assess for cancer progression. Selective delayed curative intervention is implemented only with disease progression based on predefined criteria, thereby maximizing preservation of quality of life.(6)

Many research strategies have traditionally focused on improving the detection of prostate cancer by increasing the number of biopsy cores sampled(11), using pre-biopsy nomograms(12, 13) or utilizing serum biomarkers(14-16), amongst others methods. Minimal data is published regarding means to decrease prostate biopsy rates and the burden of prostate cancer detection. With increasing awareness of morbidity associated with Transrectal ultrasound-biopsy, increasing biopsy frequency with AS protocols and recognition of the indolent nature of many newly diagnosed prostate cancers, a need exists to develop prediction models to foster clinician and patient decision-making on appropriate prostate biopsy deferral.

In addition to traditional clinical parameters such as age, PSA and DRE status, biologic markers can be used to help refine predictive algorithms for prostate cancer detection.(17) Addition of the adipokine panel is superior to clinical data alone at distinguishing patients with low risk prostate cancer compared to those with high risk disease with an area under curve of 0.75 (95%CI 0.67-0.83) for the clinical data only versus 0.79 (95%CI 0.71-0.86) for the model including adipokines (p=0.0532).

These data support research incorporating various adipokines into prostate cancer prediction models. Specifically, a predictive model incorporating both clinical and biological markers of disease to help identify patients in whom prostate biopsy can be deferred or avoided completely would be extremely useful from a patient satisfaction, a resource utilization and a morbidity reduction perspective.

Study Data Provided

Study ARI40006: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Study ARI103094: ARI103094-Follow-Up Study for REDUCE Study Subjects

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation