Studies a gene test to guide salvage radiotherapy for prostate cancer
Checks a gene test for men with prostate cancer returning after surgery.
Key facts
- Who runs it
- Regina Elena Cancer Institute
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation
- Status
- Recruiting
- People taking part
- 103 people, planned
- Started
- 4 Nov 2024
- Expected to end
- 4 Nov 2027
- Type of study
- Observational
- Record updated
- 25 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that came back after prostate removal surgery. They must already be in the "esSBRT" study at IRE, which uses short, high-dose radiotherapy.
- Sex
- Men only.
- Disease stage
- Prostate cancer with a rising PSA after radical prostatectomy (biochemical recurrence). Must already be in the "esSBRT" study.
- Earlier treatment
- Radical prostatectomy (prostate removal surgery).
- Biomarker or test result
- The Decipher® genomic test, based on 22 RNA genes, is being validated in this study.
Main reasons for not taking part
- Anyone who meets an exclusion criterion of the "esSBRT" study
- Anyone not enrolled at IRE in the "esSBRT" study
- Anyone who has not given written informed consent
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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)
Who cannot take part
- all exclusion criteria adopted for the "esSBRT" study
Where in Italy
- IRCSS Regina ElenaRoma, ItalyContact: Giuseppe Sanguineti, Head PhysicianTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
Validating the Decipher® genomic classifier based on the expression of 22 RNA genes in the prospective study "esSBRT"
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation
- Plain-language title
- Studies a gene test to guide salvage radiotherapy for prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 March 2025