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
Sex
MALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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)
Exclusion Criteria:
* all exclusion criteria adopted for the "esSBRT" study.
Primary outcome measure(s)
Biochemical disease progression — 36 months 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.
Trial sites (1)
Facility
City
Region
Status
IRCSS Regina Elena
Roma
Italy
Recruiting
More Regina Elena Cancer Institute trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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