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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03511235
Other study ID # URO-009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2018
Est. completion date July 31, 2018

Study information

Verified date October 2020
Source Myriad Genetic Laboratories, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 774
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers
Gender Male
Age group N/A to 80 Years
Eligibility 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 5a-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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Michigan Urology Cancer Center Ann Arbor Michigan
United States Urological Associates Colorado Springs Colorado
United States Pacific Urology Concord California
United States Dr. Jeffrey Glaser, Urologist Lake Saint Louis Missouri
United States Arkansas Urology Little Rock Arkansas
United States Memorial Sloane Kettering Cancer Center New York New York
United States Kar Urology Orange California
United States Golden Gate Urology San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of BCR or metastasis after selection of active surveillance (AS) 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. Up to five years post Prolaris report
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