NCT02034825

Multi-site Decision Impact Study for Decipher

ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: GenomeDx Biosciences Corp · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

Detailed description

The clinical utility of Decipher will be evaluated at two time-points: 1. Post RP - within 6 months after surgery 2. PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome. The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients. Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ): 1. Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case. 2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Decipher Questionnaire	Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-01-14
• Last updated: 2016-02-29

Locations

3 sites across 1 country: United States