Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02209584

Acronym

PROCEDE-2000

Enrollment

274

Registered

2014-08-06

Start date

2014-05-31

Completion date

2015-12-08

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).	1 months

Secondary

Measure	Time frame
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).	1 month

Other

Measure	Time frame
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

Countries

United States

Outcome results