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

N/ACompletedNCT02080689

GenomeDx Biosciences Corp286 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

286

Conditions

Prostate Cancer

Interventions

DecipherOTHER

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pathological T3 stage of disease (i.e., EPE or SVI), or 2. Positive surgical margins, or 3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations Exclusion Criteria: 1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery 2. For salvage setting patients: Metastatic Disease at PSA rise 3. Failure of PSA to nadir after surgery 4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy 5. Received any adjuvant chemotherapy 6. Required patient clinical data is not available for evaluation of eligibility criteria 7. For adjuvant setting patients, any treatment received after surgery 8. For salvage setting patients, lack of documented treatment or management recommendation on file 9. Tissue specimen is inadequate for sampling and analysis

Locations (19)

Alaska Urology Institute Alaska Clinical Research Center

Anchorage, Alaska, United States

Cedars-Sinai Medical Center

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

Measure the number of participants for which treatment was Increased or decreased in the intensity.

This outcome will compare recommended treatment pre-Decipher to recommended treatment post-Decipher

Time frame: 3 months

The number of different treatment plans most influenced by Decipher as a measure of clinical utility

Time frame: 12 months

Comparison of type of treatment plans between high risk and low risk patients

How many treatment plans are similar for those considered at high versus low risk by Decipher test

Time frame: 6 months

Account for the number of specific treatment assignments that correlated with a change in treatment recommendation

Time frame: 12 months

Frequency of follow visits as a measure of reproducibility

The extent to which the Decipher test results influence urologist recommendations on frequency of follow-up for patients

Time frame: 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

Time frame: 3 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

Data from ClinicalTrials.gov

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