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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-4dkhh3 |
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Date of registration:
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29/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Initial prostate biopsy: 12 versus 20 cores - prospective study
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Scientific title:
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20 core transrectal prostate biopsy is the initial approach of choice in a selected group of patients with suspected prostate adenocarcinoma |
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Date of first enrolment:
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01/07/2014 |
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Target sample size:
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Recruitment status: |
Data analysis completed |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-4dkhh3 |
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Study type:
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Intervention |
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Study design:
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An open randomized non-controlled diagnostic trial, parallel, with two arms.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Raphael
Sandes Solha |
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Address:
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Rua Napoleão de Barros, 800 - Vila Clementino 5576-4848
04024-002
São Paulo
Brazil |
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Telephone:
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+55-11-55764848 |
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Email:
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r_solha@hotmail.com |
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Affiliation:
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Universidade Federal de São Paulo |
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Name:
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Raphael
Sandes Solha |
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Address:
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Rua Napoleão de Barros, 800 - Vila Clementino 5576-4848
04024-002
São Paulo
Brazil |
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Telephone:
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+55-11-55764848 |
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Email:
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r_solha@hotmail.com |
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Affiliation:
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Universidade Federal de São Paulo |
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Key inclusion & exclusion criteria
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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: Previous prostate biopsy and/or prostatic-specific antigen greater than 20 ng/ml
Age minimum:
Age maximum:
Gender:
M
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of prostate
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Intervention(s)
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Procedure/surgery
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E01.370.225.500.384.100.370
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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, and a spring-loaded biopsy gun.
Dividing the prostate in apex, middle, and base, right and left side, one paramedian core and one lateral core of each segment was sampled.
Twenty core group (91 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, and a spring-loaded biopsy gun.
Dividing the prostate in apex, middle, and base, right and left side, one paramedian core and one lateral core of each segment was sampled and two additional cores were obtained from the prostate middle and base segments on each side.
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Z12.5
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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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.
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Source(s) of Monetary Support
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Fundação de Apoio à Universidade Federal de São Paulo
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Coordenação de Aperfeicoamento de Pessoal de Nível Superior
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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