Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

• Conditions: Prostatic Neoplasms; Digital Rectal Examination; Benign Prostatic Hyperplasia

• Registration Number: NCT03479359
• Lead Sponsor: Changhai Hospital

Brief Summary

The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.

Detailed Description

Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.

Study Timeline

• Study Start: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-24
• Last Update Submitted: 2018-03-24
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27
• Primary Completion: 2019-02-26
• Study Completion: 2019-02-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 700

Inclusion Criteria

• Internship just graduate from the medical school, and agree to attend the study.
• Internship have less than 5 DREs of prostate cancer.
• Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA>4ng/ml, fPSA/tPSA<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.

Exclusion Criteria

• Internship who are not willing to attend the study.
• Internship stop doing DRE for continuously 3 months after entering the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy	One year	To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.	One year	To compare the sensitivity and specificity of DRE to fPSA/tPSA and MRI (not any patients are required to have MRI examination of prostate, this will be determined at the discretion of attending doctor) to reference standard of prostate biopsy.
Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy	One year	To examine the sensitivity and specificity of the DRE performed by internship (group 1 with routinely review of pathologic outcome of prostate biopsy twice a month, and group 2 internship who are not told the results of prostate biopsy) to standard reference of prostate biopsy.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China