NCT06894628

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"

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2024Nov 2027

Study Start

First participant enrolled

November 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2027

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 18, 2025

Last Update Submit

March 18, 2025

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Biochemical disease progression

    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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCSS Regina Elena

Roma, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Giuseppe Sanguineti, Doctor

    IRCCS National Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Sanguineti, Doctor

CONTACT

+39-06 52663010giuseppe.sanguineti@ifo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

November 4, 2024

Primary Completion (Estimated)

November 4, 2027

Study Completion (Estimated)

November 4, 2027

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

IT(1)