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Recruiting NCT06866041

Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance

No phase Interventional Low-Risk Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mpMRI-targeted confirmatory biopsy.
Who it may be relevant to
Registry conditions: Low-Risk Prostate Cancer. Basic parameters: 45 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance

Overview

This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo: * PSMA PET with calculation of SUVmax and PRIMARY-Likert score * Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies * Immunohistochemistry on diagnostic prostate biopsies * Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.

Interventions

  • Procedure mpMRI-targeted confirmatory biopsy
    mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines

Primary outcome measures

  • Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance" [Time frame: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)]

Eligibility criteria

Inclusion criteria

  • Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
  • Non-metastatic status at study inclusion (patient enrollment).
  • No prior or concomitant androgen deprivation therapy
  • Ability to understand a written informed consent and willingness to sign it.

Exclusion criteria

  • Unable to tolerate a PSMA-PET scan
  • Unwillingness to be managed with AS
  • Receipt of neoadjuvant or curative-intent therapies
  • Pacemaker
  • Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT06866041 · PSMA-AS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗