Objective: To establish the incidence of prostate cancer (PCa) in Sicily in patients who entered an early detection protocol.
Methods: From February 2002 to February 2004, 16,298 subjects aged 40-75 entered the protocol. Patients with suspicious DRE, PSA>10 ng/ml, PSA<or=2.5 ng/ml, from 2.6 to 4 ng/ml or from 4.1 to 10 ng/ml with F/T PSA of <or=15%, <or=20% and <or=25% respectively underwent needle biopsy according to an extensive protocol.
Results: 3266 patients were eligible for biopsy; PSA was <or=4 in 12.7% and <or=10 ng/ml in 63.9% of patients. A PCa was found in 1171 cases (36.9%) with a relationship between PCa incidence and PSA and age respectively (chi2-test, p<0.0001); 51.8% of patients with PCa had a PSA<10 and 8.8% a PSA<4 ng/ml; 49% were clinically staged as T1c. The estimated odds ratios for each age group showed increased risk for PCa in the fourth decade with PSA between 2.6 and 4 ng/ml (12.5 times higher) and in the fifth decade with PSA between 4.1 and 10 ng/ml (6.2 times higher).
Conclusions: Age and serum PSA levels are the major risk factors for PCa. On their basis it is possible to modulate the most suitable timing for early diagnosis in individual patients.