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Optimizing the Number of Systematic COres During a MRI Target Biopsy

2019-12-09 00:56:34 | BioPortfolio

Summary

This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.

Study Design

Conditions

Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate

Intervention

Prostate biopsy

Location

IRCCS San Raffaele
Milan
Italy
20132

Status

Recruiting

Source

IRCCS San Raffaele

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-09T00:56:34-0500

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Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Removal of all or part of the PROSTATE, often using a cystoscope and/or resectoscope passed through the URETHRA.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

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