ClinicalTrials.gg
CompletedNCT03511235URO-009LowUpdated Oct 6, 2020

Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing

An observational study in Prostate Cancer, sponsored by Myriad Genetic Laboratories, Inc.. Completed at 8 sites in United States. Open to male participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by Myriad Genetic Laboratories, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
774
Ages
Up to 80 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 3,595 studies in Prostatic Neoplasms with a site in United States — 607 open to participants now, 977 under way, 101 of them phase 3. Prostatic Neoplasms · United States.

Enrollment
120th of 477
774 · median 157
Started
2018
with 147 others
Observational
482 of 3,595
99 open now
Registered
2,206th of 3,595
by date

Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 120th largest by enrollment of the 477 observational ones that give a count, is one of 148 that started in 2018, is one of 482 observational ones, and was the 2,206th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

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Open to participants now

607 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

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All 607 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: Up to 80 Years · male.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Prostate Cancer

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04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Prolaris-tested men diagnosed with low-risk prostate cancer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic .
  • Over 80 years of age at diagnosis.
  • History of hypogonadism at the time of diagnosis.
  • Co-occurring , excluding non-melanoma skin cancer.
  • Enrolled in another study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
774 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to five years post Prolaris report

07

Study locations

8 sites
  • Arkansas Urology
    Little Rock, Arkansas 72211, United States
  • Pacific Urology
    Concord, California 94520, United States
  • Kar Urology
    Orange, California 92868, United States
  • Golden Gate Urology
    San Francisco, California 94114, United States
  • Urological Associates
    Colorado Springs, Colorado 80907, United States
  • University of Michigan Urology Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Dr. Jeffrey Glaser, Urologist
    Lake Saint Louis, Missouri 63367, United States
  • Memorial Sloane Kettering Cancer Center
    New York, New York 10065, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2018
First posted
Apr 27, 2018
StartActual
Mar 12, 2018
Primary completionActual
Jul 31, 2018
CompletionActual
Jul 31, 2018
Last update
Oct 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03511235
Lead sponsor
Myriad Genetic Laboratories, Inc.
Responsible party
Sponsor
First posted
Apr 27, 2018
Start date
Mar 12, 2018
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018
Last update
Oct 6, 2020

Study contacts

Bryan M Dechairo, PhD
study director · Myriad Genetics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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