Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 10/24/2018 |
| Start Date: | March 12, 2018 |
| End Date: | July 31, 2018 |
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.
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.
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.
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.
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.
We found this trial at
8
sites
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