Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation

NCT ID: NCT06894628

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2027-11-04

Brief Summary

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"

Detailed Description

The esSBRT study ("Early salvage stereotactic radiotherapy (esSBRT) for biochemical recurrence after radical prostatectomy: a phase II study", RS1705/22 - opinion of the Central Ethics Committee IRCCS Lazio, Section IFO - Fondazione Bietti of 4 August 2022; NCT05667636) is a prospective phase II study developed and currently active at the Institute's Radiotherapy Unit, in which patients with biochemical recurrence of the disease after RP are treated on the prostatic lodge, and possibly on the pelvic lymph node stations, with hypofractionated radiotherapy in 5 sessions (5 Gy/fx). The aim is to be able to have a genomic classifier, such as Decipher®, for the patients enrolled in this protocol in order to complete the predictive evaluation. Furthermore, the project plans to profile PCa samples using a 'Comprehensive' panel of about 500 genes that allows to identify a specific molecular profile in the respective risk classes (low, intermediate and high) stratified with Decipher®. This evaluation would allow to identify the mutational structure of prostate cancer in an early stage of the disease, in particular by identifying the molecular alterations of the genes involved in homologous recombination repair (HRR) such as BRCA1, BRCA2, ATM, CDK12, CHEK2, PALB2.

The hypothesis is that the Decipher® risk classes (low, intermediate and high) correspond to a different risk of biochemical disease progression (defined as an increase in total PSA of 0.2 ng/ml above the nadir) independently or in addition to conventional clinicopathological criteria.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Sanguineti, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS National Cancer Institute

Locations

IRCSS Regina Elena

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Sanguineti, Doctor

Role: CONTACT

giuseppe.sanguineti@ifo.it

+39-06 52663010

Facility Contacts

Giuseppe Sanguineti, Head Physician

Role: primary

giuseppe.sanguineti@ifo.it

Other Identifiers

RS248/24/IRE

Identifier Type: -

Identifier Source: org_study_id