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A Tailored Polygenic Risk Score for Predicting Progression in Prostate Cancer Under Active Surveillance

NCT07491406 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 185

Last updated 2026-05-15

No results posted yet for this study

Summary

Prostate cancer is the most common malignancy in men, and in patients with low-risk disease, active surveillance represents the preferred initial approach to avoid unnecessary treatments. However, up to 50% of men under active surveillance develop clinical progression or histological upgrading within five years, making improved risk stratification essential.

A family history of prostate cancer is a well-established risk factor and reflects the importance of genetic predisposition. Genome-wide studies have identified numerous common variants associated with disease risk, enabling the development of polygenic risk scores (PRS) that integrate the effects of multiple genetic loci. Recent evidence suggests that these PRS may also correlate with tumor aggressiveness and the likelihood of progression in patients undergoing active surveillance.

This study aims to analyze 185 patients, stratified according to the presence or absence of family history and progression during active surveillance, using germline DNA that has already been biobanked and analyzed with the Axiom™ PMDA array. PRS will be calculated as a weighted sum of risk variants. The objective is to identify PRS models capable of accurately predicting progression, with particular focus on men with a family history, thereby improving the personalization of clinical monitoring. By integrating genomic and clinical data, the study seeks to support a precision oncology approach in patients with early-stage prostate cancer.

Conditions

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2025-12-31
Completion
2026-03-18

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07491406 on ClinicalTrials.gov