Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01827813
• Lead Sponsor: TC Erciyes University

Brief Summary

OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012 were retrospectively assessed. Patients with an abnormal digital examination findings and/or abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated biopsy was determined as the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was accepted as statistically significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2012-06
• Study Completion: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

Inclusion Criteria

1. Abnormal digital examination
2. High serum prostate specific antigen (PSA) level.
3. The continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP).

Exclusion Criteria

1. Patients with coagulopathies
2. Patients with unsuitable general conditions for prostate biopsy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection rate of prostate cancer.	At least two months	Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.

Trial Locations

Locations (1)

Department of Urology, Ercieys University, Faculty Of Medicine,; 🇹🇷 Kayseri, Turkey