An observational study in Prostatic Neoplasms, Digital Rectal Examination and Benign Prostatic Hyperplasia, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to male participants. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by Changhai Hospital · Observational
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.
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.
All included internship are graduated from the Second Military Medical University and have already get the M.D. degree
Exclusion Criteria:
In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month.
Behavioral: Routine review of DRE results by attending doctors
In this group, internship are not given the pathology outcome of each prostate biopsy.
Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.
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.
Time frame: One year
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.
Time frame: One year
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.
Time frame: One year
Plan to share: Yes — IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Changhai Hospital