Clinical trial · Observational
Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
NCT03479359CI-TRIAL-00032257unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Digital Rectal Examination | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine review of DRE results by attending doctors | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month.
- interventionNames
- Behavioral: Routine review of DRE results by attending doctors
- label
- Group 2
- description
- In this group, internship are not given the pathology outcome of each prostate biopsy.
Primary outcomes (1)
- measure
- Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
- timeFrame
- One year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDHalpern JA, Oromendia C, Shoag JE, Mittal S, Cosiano MF, Ballman KV, Vickers AJ, Hu JC. Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer. J Urol. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20. PMID 29061540
- BACKGROUNDClements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, Krupski TL. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency. J Surg Educ. 2018 Mar-Apr;75(2):434-441. doi: 10.1016/j.jsurg.2017.08.012. Epub 2017 Oct 12. PMID 28923535