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NCT Number: NCT06866041

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

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.

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Key information

Conditions

Low-Risk Prostate Cancer

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mpMRI-targeted confirmatory biopsy

Procedure

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

Other names: 18F-PSMA PET/MRI, WES and spatial transcriptomics on the diagnostic biopsy specimens, Multiplex immunohistochemistry on the diagnostic biopsy specimens

Primary outcomes

  1. 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)

    To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS).

Study contacts

Contact information is provided by the study sponsor or research team.

Giorgio Gandaglia

CONTACT

[email protected]

+39 0226438068

Lucia Dambrosio

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Acronym: PSMA-AS

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Mar 10, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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