NCT02080689

Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery

PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: GenomeDx Biosciences Corp · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Detailed description

This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP: 1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR) 2. In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations) A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases. As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Decipher

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2014-03-06
• Last updated: 2017-02-27

Locations

19 sites across 1 country: United States