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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827813
• Other study ID #: ProstatBX
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: April 9, 2013
• Start date: June 2007
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Transrectal prostate biopsy with ultrasonography.
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.
• Periprostatic block
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.
• Sedoanalgesia
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.

Locations

Country	Name	City	State
Turkey	Department of Urology, Ercieys University, Faculty Of Medicine,	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of prostate cancer.	Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.	At least two months	Yes