Benign prostatic hypertrophy
Conditions
Brief summary
Proportion of patients undergoing a repeat prostate biopsy within 12 months
Detailed description
ln[PSA] value measured at 12 months, PINS score at 12 months, PIRADS score at 12 months, Number of lesions at 12 months, IS and IRANI score at 12 months, IPSS and IIEF-5 at 12 months, Proportion of patients diagnosed with prostate cancer within 12 months
Interventions
DRUGPERMIXON 160 mg
DRUGgélule
DRUGPlacebo matching Macrogol 6000. Non-authorised product
DRUGmanufactured specifically for this clinical trial by Pierre Fabre Medicament Production (MIA No. 2025 247 1 2) and packaged/labelled/batch released by Creapharm (MIA No. 2025 001 1 2 4 10). One hard capsule contains only 350 mg Macrogol 6000. No active substance. EU MP number: not applicable. Marketing Authorisation: not applicable.
Sponsors
Azienda Ospedaliero Universitaria Careggi, University Of Florence
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients undergoing a repeat prostate biopsy within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ln[PSA] value measured at 12 months, PINS score at 12 months, PIRADS score at 12 months, Number of lesions at 12 months, IS and IRANI score at 12 months, IPSS and IIEF-5 at 12 months, Proportion of patients diagnosed with prostate cancer within 12 months | — |
Outcome results
None listed