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Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03479359
Enrollment
700
Registered
2018-03-27
Start date
2018-02-26
Completion date
2019-02-26
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Digital Rectal Examination, Prostatic Neoplasms

Keywords

Prostate cancer; Benign Prostatic Hyperplasia; Digital Rectal Examination; Accuracy

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.

Interventions

BEHAVIORALRoutine review of DRE results by attending doctors

Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsyOne yearTo 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

MeasureTime frameDescription
Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsyOne yearTo 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.
Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.One yearTo 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.

Countries

China

Contacts

Primary ContactShuxiong Zeng, M.D., Ph.D
zengshuxiong@126.com+86 18930568759
Backup ContactXiong Qiao, M.D., Ph.D
xiongqiao1990@126.com+86 02131161725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026