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Clinical Trials/NCT02080689
NCT02080689CompletedNot Applicable

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

GenomeDx Biosciences Corp37 sites in 1 country286 target enrollmentStarted: May 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
286
Locations
37
Primary Endpoint
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pathological T3 stage of disease (i.e., EPE or SVI), or
  • •Positive surgical margins, or
  • •Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion Criteria

  • •For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
  • •For salvage setting patients: Metastatic Disease at PSA rise
  • •Failure of PSA to nadir after surgery
  • •Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
  • •Received any adjuvant chemotherapy
  • •Required patient clinical data is not available for evaluation of eligibility criteria
  • •For adjuvant setting patients, any treatment received after surgery
  • •For salvage setting patients, lack of documented treatment or management recommendation on file
  • •Tissue specimen is inadequate for sampling and analysis

Outcomes

Primary Outcomes

Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices

Time Frame: 3 months

Secondary Outcomes

  • Frequency of follow visits as a measure of reproducibility(12 months)
  • Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool(3 months)
  • The number of different treatment plans most influenced by Decipher as a measure of clinical utility(12 months)
  • Measure the number of participants for which treatment was Increased or decreased in the intensity.(3 months)
  • Account for the number of specific treatment assignments that correlated with a change in treatment recommendation(12 months)
  • Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance(12 months)
  • Evaluate number of participants which show coherence to treatment decisions(12 months)
  • Comparison of type of treatment plans between high risk and low risk patients(6 months)
  • A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients(12 months)

Investigators

Sponsor
GenomeDx Biosciences Corp
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (37)

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