About this trial
The study aims to validate the Decipher® genomic test, in which patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ Gy/fraction).
Validating the Decipher® genomic classifier based on the expression of 22 RNA genes in the prospective study "esSBRT"
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients enrolled at IRE under the "esSBRT" protocol (meeting the criteria of the same);
patients who express written informed consent personally or through their legal representative/witness/curator/guardian/support administrator (participation in the ancillary study and data processing)
Disqualifiers
all exclusion criteria adopted for the "esSBRT" study.
Trial population
Patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ Gy/fraction).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Biochemical disease progression
The hypothesis that the Decipher® risk classes (low, intermediate and high) correspond to a different risk of biochemical disease progression will be measured as an increase in total PSA -prostate specific antigen- of 0.2 ng/ml above the nadir, independently or in addition to conventional clinicopathological criteria.
Sponsors and contacts
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