Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population

April 13, 2024 updated by: Hao Zeng, West China Hospital

Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population: Temporal Trend, Targeted and Repeat Biopsies, and Pathological Characterization: Comparative Study - Retrospective Cohort

Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.

Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective study analyzed data from 10,038 patients suspected of PCa who underwent transperineal PBx at our medical center, from 2011 to 2022.

Description

Inclusion Criteria:

  • Patients suspected of PCa who underwent transperineal PBx at our medical center, from 2011 to 2022

Exclusion Criteria:

  • Patients with other cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive rate of prostate biopsy
Time Frame: 10 Years
The investigators intend to analyze the variation in the positivity rate of prostate biopsies over several years.
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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