Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
NCT ID: NCT06866041
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
74 participants
INTERVENTIONAL
2025-05-07
2030-03-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
mpMRI-targeted confirmatory biopsy
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Interventions
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mpMRI-targeted confirmatory biopsy
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
MALE
No
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Giorgio Gandaglia
Medical Doctor
Locations
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IRCCS Ospedale San Raffaele
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PSMA-AS
Identifier Type: -
Identifier Source: org_study_id
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