NCT07491406Completed
A Tailored Polygenic Risk Score for Predicting Progression in Prostate Cancer Under Active Surveillance
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 185 (actual)
- First submitted
- 18 Mar 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07491406
What you commit to
- Study type: Observational
- Participants enrolled: 185
- From 1 Jan 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to perform the confirmatory biopsy required by the active surveillance protocol.
Other
- Absence of a biological sample available in the biobank.
- Lack of complete clinical data related to diagnosis or follow-up during active surveillance.
- Lack of information on family history.
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.