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

Last updated: May 13, 2025
Sponsor: Università Vita-Salute San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

mpMRI-targeted confirmatory biopsy

Clinical Study ID

NCT06866041
PSMA-AS
  • Ages 45-80
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsyISUP 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

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 Design

Total Participants: 74
Treatment Group(s): 1
Primary Treatment: mpMRI-targeted confirmatory biopsy
Phase:
Study Start date:
May 07, 2025
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • IRCCS Ospedale San Raffaele

    Milan, 20132
    Italy

    Active - Recruiting

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