Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients

May 29, 2015 updated by: Myriad Genetic Laboratories, Inc.

An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients

This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Recently diagnosed treatment-naïve patients with early stage localized prostate cancer

Description

Inclusion Criteria:

  • Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
  • Clinically localized (no evidence on clinical or imaging studies of advanced disease).
  • No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
  • Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

  • Patients with a known history of hypogonadism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation)
Time Frame: 1 month
1 month
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.
Time Frame: 2 months
2 months

Other Outcome Measures

Outcome Measure
Time Frame
• The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myriad Genetic Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROCEDE-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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