Multi-site Decision Impact Study for Decipher
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | January 2015 |
ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
This prospectively designed retrospective clinical utility study will evaluate urologists'
treatment recommendations before and after reviewing Decipher results for selected patient
cases.
treatment recommendations before and after reviewing Decipher results for selected patient
cases.
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.
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.
Inclusion Criteria:
Patient cases eligible for this study were treated with radical prostatectomy and have one
or more adverse features present as defined by AUA and NCCN guidelines:
- Pathological T3 stage of disease (i.e., ECE or SVI)
- Positive surgical margins, or
- Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent
determinations
Exclusion Criteria:
1. Metastatic Disease (M+) prior to surgery
2. Failure of PSA to nadir after surgery
3. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
4. Received any adjuvant chemotherapy
5. Required patient clinical data (Section 5.3) is not available for evaluation of
eligibility criteria
6. Lack of documented treatment or management recommendation on file
7. Tissue specimen is inadequate for sampling and analysis
We found this trial at
3
sites
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