Back to resultsComparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transrectal prostate biopsy with ultrasonography.
Periprostatic block
Sedoanalgesia
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate-specific antigen, digital rectal examination, transrectal ultrasonography, needle biopsy, prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Abnormal digital examination
- High serum prostate specific antigen (PSA) level.
- 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:
- Patients with coagulopathies
- Patients with unsuitable general conditions for prostate biopsy.
Sites / Locations
- Department of Urology, Ercieys University, Faculty Of Medicine,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Saturation biopsy
10-12 core biopsy
Arm Description
Saturation biopsy was performed in left lateral decubitus position after application of sedo-analgesia by the anesthesiologists on an outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen. As a total,24,26 or 28 biopsies were taken depending on prostate volume.
10-12 core biopsy was performed in left lateral decubitus position without sedo-analgesia on an outpatient basis. After preparation of the probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. As a total 10 or 12 core biopsies were taken depending on prostate volume. The biopsies were taken form right base, right mid, right apex, right far-lateral base, right far-lateral mid and left base, left apex, left far-lateral base, and left far-lateral mid in 10 core biopsy, also two additional transitional zone biopsies were taken in 12 core biopsies.
Outcomes
Primary Outcome Measures
Detection rate of prostate cancer.
Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01827813
Brief Title
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
Official Title
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate-specific antigen, digital rectal examination, transrectal ultrasonography, needle biopsy, prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saturation biopsy
Arm Type
Active Comparator
Arm Description
Saturation biopsy was performed in left lateral decubitus position after application of sedo-analgesia by the anesthesiologists on an outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen. As a total,24,26 or 28 biopsies were taken depending on prostate volume.
Arm Title
10-12 core biopsy
Arm Type
Active Comparator
Arm Description
10-12 core biopsy was performed in left lateral decubitus position without sedo-analgesia on an outpatient basis. After preparation of the probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. As a total 10 or 12 core biopsies were taken depending on prostate volume. The biopsies were taken form right base, right mid, right apex, right far-lateral base, right far-lateral mid and left base, left apex, left far-lateral base, and left far-lateral mid in 10 core biopsy, also two additional transitional zone biopsies were taken in 12 core biopsies.
Intervention Type
Procedure
Intervention Name(s)
Transrectal prostate biopsy with ultrasonography.
Intervention Description
Transrectal prostate biopsy was performed in left lateral decubitus position with sedo-analgesia in saturation biopsy group and without sedoanalgesia in 10-12 core biopsy group on outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. Periprostatic block was performed with the injection of 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region in both groups before biopsy. Biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen.
Intervention Type
Procedure
Intervention Name(s)
Periprostatic block
Intervention Description
Periprostatic block was used for local anesthesia. 3 cc 2% prilocaine was injected to both periprostatic region in both saturation biopsy and 10-12 core biopsy group with transrectal ultrasonography.
Intervention Type
Procedure
Intervention Name(s)
Sedoanalgesia
Intervention Description
Sedoanalgesia was used in saturation biopsy group. It was given by an anesthesiologist. Patients were given adequate counselling regarding sedoanesthesia as well as the biopsy procedure. They were advised to fast the night before the procedure.Before induction of sedoanalgesia all patients were monitorized for peripheric oxygen saturation and electrocardiography (ECG).Additionally nasal oxygen with 3ml/min was given to all patients by nasal canula.Sedoanalgesia was induced with 0.05mg/kg of midazolam, 1mg/kg of propofol and 1mg/kg of fentanyl. additional propofol was given with dose of 0.3mg/kg as patients needed.
Primary Outcome Measure Information:
Title
Detection rate of prostate cancer.
Description
Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.
Time Frame
At least two months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Abnormal digital examination
High serum prostate specific antigen (PSA) level.
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:
Patients with coagulopathies
Patients with unsuitable general conditions for prostate biopsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Demirtas, Assistant Prof., MD
Organizational Affiliation
Erciyes University, Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akın Avcı, Resident in UrologyMD,
Organizational Affiliation
Erciyes University, Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibrahim Gulmez, Professor in Urology,M.D.
Organizational Affiliation
Erciyes University, Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Ercieys University, Faculty Of Medicine,
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
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