Study: NCT04854343

Intervention type: DIAGNOSTIC_TEST
Intervention: Secretory leukocyte protease inhibitor (SLPI) in prostate cancer
Description: 7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the Human SLPI Quantikine ELISA Kit. SLPI level will be measured at diagnosis and during the follow-up (3, 9, 15 months and in case of progression).~Immunohistochemistry protocol for SLPI immunostaining to investigate SLPI levels prostate tissue

Intervention type: DIAGNOSTIC_TEST
Intervention: Determination of molecular alterations
Description: The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.

Intervention type: DIAGNOSTIC_TEST
Intervention: Determination of molecular alterations
Description: The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.

Intervention type: DIAGNOSTIC_TEST
Intervention: Secretory leukocyte protease inhibitor (SLPI) Healthy
Description: SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).~7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the Human SLPI Quantikine ELISA Kit.

Intervention type: DIAGNOSTIC_TEST
Intervention: Secretory leukocyte protease inhibitor (SLPI) Healthy
Description: SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).~7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the Human SLPI Quantikine ELISA Kit.