First Cluster randomized study within SPRINTR

This SPRINTR-TRIAL will identify the primary outcome, risk of infection, from SPRINTR-Real. By leveraging the data in the SPRINTR-Real database, which will include hospital admissions, any prescribed drugs, or new diagnoses in any hospital or other caregiver in Sweden every three months, no specific e-CRF is needed.   

We hope this will be the first of many trials using the SPRINTR-REAL data, in combination with the core outcome set collected for research use under SPRINTR-REAL's ethical approval, for the SPRINTR-TRIAL, thereby reducing the complexity and cost of the trial. 

Study design

Hospitals will be randomized to use either the Forsvall needle or their previously used needle. All men will be diagnosed using the same needles based on randomization. In the next step, a crossover will let the hospital switch needles. 

Primary endpoint

Use of antibiotics or diagnosis of any urinary tract infection within 30 days after biopsy

Secondary endpoints

Risk of hospital admission within 30 days for urinary tract infection after biopsy

An increased number of high-grade prostate cancer from PI-RADS 5 lesions 

SPRINTR-TRIAL 3 is currently a proposed study, with a planned start in 2027.