Clinical trial · Interventional
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mpMRI-targeted confirmatory biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- 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.
- interventionNames
- Procedure: mpMRI-targeted confirmatory biopsy
Primary outcomes (1)
- measure
- Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
- timeFrame
- Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available