Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance (PSMA-AS)

May 13, 2025 updated by: Giorgio Gandaglia, Università Vita-Salute San Raffaele

Biological Pathways and Next-Generation Imaging Features Predicting 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm

All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo:

  • PSMA-PET/MRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score).
  • Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies.

Confirmation biopsy one year after diagnosis, according to international guidelines.
Procedure: mpMRI-targeted confirmatory biopsy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

May 7, 2028

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMA-AS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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