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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366308
• Other study ID #: ProBiox
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with other cancers

Related Conditions & MeSH terms

• Pathology
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Transperineal Prostate Biopsy
The investigators plan to retrospectively review data from over 10000 men receiving transperineal prostate biopsy in our center.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of prostate biopsy	The investigators intend to analyze the variation in the positivity rate of prostate biopsies over several years.	10 Years