NCT02209584

Brief Summary

This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2015

Completed
Last Updated

September 5, 2017

Status Verified

May 1, 2015

Enrollment Period

12 months

First QC Date

April 29, 2014

Last Update Submit

August 31, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).

    1 months

Secondary Outcomes (1)

  • Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).

    1 month

Other Outcomes (2)

  • Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.

    1 month

  • 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.

    1 month

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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 agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
  • Sufficient amount of tissue remains from biopsy to perform genomic testing.

You may not qualify if:

  • Patients with known history of hypogonadism will be excluded from the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Richard Wenstrup, MD

    Myriad Genetic Laboratories, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

August 6, 2014

Study Start

May 1, 2014

Primary Completion

April 15, 2015

Study Completion

December 8, 2015

Last Updated

September 5, 2017

Record last verified: 2015-05

Locations

US(1)