Clinical trial NCT03511235: Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
Official title: Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 774
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prolaris-tested men diagnosed with low-risk prostate cancer.

Brief summary: Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.

Detailed description: This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.

The primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.

The secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1, 2017.
* Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.
* Have NCCN low-risk disease2.

Exclusion Criteria:

* Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.
* Over 80 years of age at diagnosis.
* History of hypogonadism at the time of diagnosis.
* Co-occurring malignancy, excluding non-melanoma skin cancer.
* Enrolled in another investigational study.

Primary outcomes:
measure: Rate of BCR or metastasis after selection of active surveillance (AS)
timeFrame: Up to five years post Prolaris report
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Concord
country: United States
facility: Pacific Urology
state: California
city: Orange
country: United States
facility: Kar Urology
state: California
city: San Francisco
country: United States
facility: Golden Gate Urology
state: California
city: Colorado Springs
country: United States
facility: Urological Associates
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan Urology Cancer Center
state: Michigan
city: Lake Saint Louis
country: United States
facility: Dr. Jeffrey Glaser, Urologist
state: Missouri
city: New York
country: United States
facility: Memorial Sloane Kettering Cancer Center
state: New York
Study officials:
affiliation: Myriad Genetics, Inc.
name: Bryan M Dechairo, PhD
role: STUDY_DIRECTOR
References: