Clinical trial NCT03479359: Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
Official title: Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Digital Rectal Examination
Benign Prostatic Hyperplasia
Keywords: Prostate cancer; Benign Prostatic Hyperplasia; Digital Rectal Examination; Accuracy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 700
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All included internship are graduated from the Second Military Medical University and have already get the M.D. degree

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
timeFrame: One year
Secondary outcomes:
measure: Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy
timeFrame: One year
measure: Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.
timeFrame: One year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Second Military Medical University
name: Chuanliang Xu, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20.
citation: 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.