Low-Risk Prostate Cancer
Conditions
Brief 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.
Interventions
PROCEDUREmpMRI-targeted confirmatory biopsy
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance | 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). |
Countries
Italy
Contacts
Primary ContactGiorgio Gandaglia
Backup ContactLucia Dambrosio
Outcome results
None listed