SPRINTR-TRIAL 2
Overview
SPRINTR‑TRIAL 2 is a biomarker‑ and AI‑guided platform trial evaluating individualized follow‑up strategies in men with low‑risk prostate cancer on active surveillance. The aim is to reduce monitoring intensity and treatment‑related side effects while maintaining non‑inferior metastasis outcomes.
SPRINTR-Real and SPRINTR-Trial integration:
Biomarker profiling phase within SPRINTR-Real
Integrates standard-of-care diagnostics with extended molecular analyses to identify actionable targets.
Treatment phase (Included in SPRINT-TRIAL 2)
Patients are allocated to experimental biomarker-based stratification follow-up and treatment arms versus the Standard of Care arm.
Active Surveillance is a huge benefit to reduce over-treatment for men with a very low risk of developing symptomatic disease. The SPCG-17 study has paved the way for treatment triggers and for the inclusion of as many as possible in standardized follow-up schemes. The present initiative has the potential to further reduce the risk to patients and decrease the workload for clinics by giving patients more control over follow-up under clinic supervision. The study will last 30 years, with the dual goal of increasing the time without treatment side effects and demonstrating non-inferiority for time to metastasis.
Study Population
The trial includes adult patients (≥18 years) with low risk to intermediate risk prostate cancer, who are fit for curative treatment if progression and have a good performance status (ECOG 0–1)
Primary Endpoints
Significance
SPRINTR‑TRIAL 2 introduces precision‑guided, patient-centered surveillance and provides a long‑term infrastructure to evaluate emerging biomarkers and interventions, with potential to reduce overtreatment and healthcare burden in prostate cancer
