Clinical Trials Logo

Clinical Trial Summary

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach. This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

Clinical Trial Description

There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate. TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique. Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate. Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation. TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy. Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone. With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions. The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer. Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions: - Differences in the risk of infectious complications - Differences in the hemorrhagic and urinary side effects - Tolerability of both techniques with local anesthesia alone - Difference in the results of of MRI/US fusion targeted biopsy - Differences in the overall cancer detection rate and the high-grade cancer detection rate - Differences in the cost of the procedures ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04081636
Study type Interventional
Source Albany Medical College
Contact Brenda Romeo, CCRC
Phone 518-262-8579
Email [email protected]
Status Recruiting
Phase N/A
Start date September 9, 2019
Completion date December 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Recruiting NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Active, not recruiting NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Active, not recruiting NCT00499421 - Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy
Not yet recruiting NCT04887935 - Neoadjuvant SGLT2 Inhibition in High-Risk Localized Prostate Cancer Phase 1
Recruiting NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Not yet recruiting NCT05035732 - RRPC Axumin PETMRI N/A
Not yet recruiting NCT05033301 - Evaluating the Effectiveness of the Nurse Ned Clinic N/A
Recruiting NCT03668652 - Focal Prostate Ablation Versus Radical Prostatectomy N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Recruiting NCT04060589 - ReIMAGINE Prostate Cancer Risk