Evaluating genomic testing and radiotherapy for prostate cancer recurrence
Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation
This study is testing if a genomic test can help guide radiation treatment for men whose prostate cancer comes back after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06894628 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Decipher® genomic test in patients who experience biochemical recurrence after radical prostatectomy. Participants will receive salvage radiotherapy using extreme hypofractionation, delivering 5 Gy per fraction over five sessions. The study will also profile prostate cancer samples to identify specific molecular alterations related to risk stratification. By correlating genomic risk classes with disease progression, the study seeks to enhance predictive evaluations for treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients who have had a radical prostatectomy and are experiencing biochemical recurrence.
Not a fit: Patients who do not meet the inclusion criteria for the esSBRT protocol or those with contraindications for salvage radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment personalization for patients with recurrent prostate cancer, potentially leading to better outcomes.
How similar studies have performed: Other studies have shown promise in using genomic classifiers for treatment stratification in prostate cancer, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma
- IRCSS Regina Elena — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Sanguineti, Doctor — IRCCS National Cancer Institute
- Study coordinator: Giuseppe Sanguineti, Doctor
- Email: giuseppe.sanguineti@ifo.it
- Phone: +39-06 52663010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.