Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

Prostatic Neoplasms Clinical Trial

Official title:

Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479359
• Other study ID #: CH-Urology-DRE-001
• Status: Recruiting
• First received: March 8, 2018
• Last updated: March 24, 2018
• Start date: February 26, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2018
• Source: Changhai Hospital
• Contact: Shuxiong Zeng, M.D., Ph.D
• Phone: +86 18930568759
• Email: zengshuxiong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Digital Rectal Examination
• Hyperplasia
• Prostatic Hyperplasia
• Prostatic Neoplasms

Intervention

Behavioral:
• Routine review of DRE results by attending doctors
Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Clements 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. — View Citation

Halpern 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. 2017 Oct 20. pii: S0022-5347(17)77762-2. doi: 10.1016/j.juro.2017.10.021. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy	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.	One year
Secondary	Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy	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.	One year
Secondary	Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.	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.	One year