invasive prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10036917 Term: Prostate cancer stage I
Conditions
Sponsors
UNIVERSITA` CAMPUS BIOMEDICO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men with histological diagnosis of prostate cancer Stage T1c or T2a disease AND PSA value of 10 ng/ml or less AND a Gleason score of 6 or less Men older than 75 years OR life expectancy of less than 10 years: PSA can be greater than 10 ng/ml OR the Gleason score can be 7 (3 + 4) Age ≥ 18 years WHO performance status 0-2 Written informed consent to all required assessments Patients must have undergone a core biopsy for the diagnosis of their prostate cancer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: T0, T1a,b, T2b,c, T3 tumours AND/OR Gleason > 7 AND/OR PSA > 10 if life expectancy > 10 years Previous hormone or radiotherapy to the treated prostate Evidence of metastatic disease or recurrent prostate cancer Previous diagnosis of malignancy unless o non-melanomatous skin cancer Serum creatinine > 1.5 x upper limit of normal reference range or calculated creatinine clearance 37.5 C) in the two weeks before the study enter Concomitant prolonged treatment with steroids (either IV or oral)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the infusion of zoledronic acid in neoadjuvant setting causes an increase in apoptotic markers between baseline and surgery, both at serum and tissue levels;Secondary Objective: "To determine whether the infusion of zoledronic acid in neoadjuvant setting causes an increase in angiogenic markers To determine whether the infusion of zoledronic acid in neoadjuvant setting causes a decrease of proliferation markers between baseline and surgery,at tissue levels(ki-67)To detect the presence of circulating tumour cells(CTCs),endothelial circulating cells(CECs)and endothelial progenitor cells(CEPs)in the peripheral blood and the presence of disseminated tumor cells(DTCs)in the bone marrow and changes in response to zoledronic acid To measure bone markers(BALP(serum),CTX(serum)and NTX(urine))at time 0,at every zoledronic acid infusion and prior to surgery To measure PSA serum levels at time 0,at every zoledronic acid infusion and prior to surgery To detect the presence of T cell subsets in the peripheral blood(taken at time 0,at every zoledronic acid infusion and prior to surgery)and changes in response to trea";Primary end point(s): Increase in apoptotic following zoledronic acid infusion in neoadjuvant setting | — |
Countries
Italy
Outcome results
None listed