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

Study Overview
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Brief Summary
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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
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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: In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR) 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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Decipher


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Salvage setting<br>The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria 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) | Other: Decipher<br> <br> |
| Other: Adjuvant setting<br>The clinical utility of Decipher will be evaluated for patients in the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR) | Other: Decipher<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| The number of different treatment plans most influenced by Decipher as a measure of clinical utility |  | 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 | 6 months | 
| Account for the number of specific treatment assignments that correlated with a change in treatment recommendation |  | 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 | 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 | 
| 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 | 
| A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients | The extent to which the Decipher test results affect patient comfort level with treatment decisions as based on QOL and treatment regret tools | 12 months | 
| Evaluate number of participants which show coherence to treatment decisions | For how many cases was the original selected treatment for a patient actually executed upon | 12 months |