Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Recruiting
N/A
Interventional Study
Low-Risk Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 45 – 80
- Sex
- Male
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 74 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 willingn…
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