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

March 18, 2025 updated by: Regina Elena Cancer Institute

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"

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ Gy/fraction).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical disease progression
Time Frame: 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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Investigators

  • Principal Investigator: Giuseppe Sanguineti, Doctor, IRCCS National Cancer institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

November 4, 2027

Study Completion (Estimated)

November 4, 2027

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS248/24/IRE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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