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

Prostate Cancer Clinical Trial

— PROCEDE-2000  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209584
• Other study ID #: PROCEDE-2000
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 31, 2017
• Start date: May 2014
• Est. completion date: December 8, 2015

Study information

• Verified date: May 2015
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: December 8, 2015
• Est. primary completion date: April 15, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.		1 month
Other	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
Primary	Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).		1 months
Secondary	Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).		1 month