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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954004
• Other study ID #: PROCEDE-1000
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: May 29, 2015
• Start date: April 2013
• Est. completion date: September 2014

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1270
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• 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 (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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

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	• 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.		4 months	No
Primary	Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).		4 months	No
Secondary	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)		1 month	No
Secondary	Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.		2 months	No