Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
N/A
40 Years
70 Years
40 Years
70 Years
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Detection rate of prostate cancer.
Outcome Description:
Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.
Outcome Time Frame:
At least two months
Safety Issue:
Yes
Principal Investigator
Abdullah Demirtas, Assistant Prof., MD
Investigator Role:
Study Director
Investigator Affiliation:
Erciyes University, Faculty of Medicine
Authority:
Turkey: Ministry of Health
Study ID:
ProstatBX
NCT ID:
NCT01827813
Start Date:
June 2007
Completion Date:
February 2013
Related Keywords:
- Prostate Cancer
- prostate-specific antigen
- digital rectal examination
- transrectal ultrasonography
- needle biopsy
- prostate cancer
- Prostatic Neoplasms
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