Status and phase
Conditions
Treatments
About
Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Only subjects who meet all of the following criteria will be eligible to participate in this study:
Male patients
Age ≥ 45 years
Suspected presence of prostate inflammatory foci, defined according to the following criteria:
PSA ≥ 2.6 ng/mL and age ≥ 50 and < 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or,
PSA ≥ 4.1 ng/mL and age ≥ 60 and < 75 years, and
normal digito-rectal examination (DRE) (see section 5.2), and normal urine test with dipstick and/or microscopy carried out within 5 days of the baseline visit
Patients willing and able to provide their written informed consent and to comply with study procedures.
Exclusion criteria
Patients who meet any of the following criteria will not be eligible to participate in this study:
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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