Clinical trial · Observational
A Tailored Polygenic Risk Score for Predicting Progression in Prostate Cancer Under Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PCa Family History
- label
- Non PCa Family History
Primary outcomes (1)
- measure
- Disease progression
- timeFrame
- at confirmatory biopsy
- description
- Disease progression during active surveillance, defined as the occurrence of histological upgrading at repeat biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of low-risk PCa (Gleason score ≤7 ) * PSA \<20 ng/mL * Clinical stage ≤T3 * Enrollment in AS with confirmatory biopsy and longitudinal follow-up * Reported family history * Signed URBAN consent * Signed protocol N. 2014 - BIOPSIE PROSTATICHE e PROSTATECTOMIE RADICALI Exclusion Criteria: * Absence of a biological sample available in the biobank. * Lack of complete clinical data related to diagnosis or follow-up during active surveillance. * Failure to perform the confirmatory biopsy required by the active surveillance protocol. * Lack of information on family history.
References
Publications (0)
Data not yet available