Malignant neoplasm of prostate
Conditions
Interventions
Twelve core group (105 participants): transrectal ultrasound guided prostate biopsy, after troncular bilateral anesthesia with 10 ml of 1% lidocaine, using a 7.5 Hz probe, an 18-gauge trucut needle, a
Procedure/surgery
E01.370.225.500.384.100.370
Z12.5
Sponsors
Universidade Federal de São Paulo
Fundação de Apoio à Universidade Federal de São Paulo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients referred for a prostate biopsy with suspected prostate cancer: positive digital rectal exam findings and/or elevated serum prostatic-specific antigen levels.
Exclusion criteria
Exclusion criteria: Previous prostate biopsy and/or prostatic-specific antigen greater than 20 ng/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Higher prostate cancer detection rate using a 20-core biopsy protocol than the standard 12-core biopsy protocol, based on the histological analysis of cores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Higher clinically insignificant prostate cancer detection rate using a 20-core biopsy protocol than the standard 12-core biopsy protocol, based on the histological analysis of cores. Clinically insignificant cancers: maximum of three positive cores, greatest percentage of cancer of 50% of core length, and Gleason score of 6 or less. ;Higher prostate cancer detection rate using a 20-core biopsy protocol than de standard 12-core biopsy protocol, based on the histological analysis of cores in patients with prostatic-specific antigen lower than 6 ng/ml, prostatic volume lower than 40 cm³ and/or younger than 60 years old. | — |
Countries
Brazil
Contacts
Public ContactRaphael Sandes Solha
Universidade Federal de São Paulo
Outcome results
None listed