Status:

UNKNOWN

A Prospective, Single-centre,Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis

Lead Sponsor:

Qilu Hospital of Shandong University

Conditions:

Prostate Carcinoma

Eligibility:

MALE

18+ years

Brief Summary

Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. For example, the s...

Detailed Description

The traditional diagnostic methods of PC include serum PSA and prostatic biopsy (PB). To screen the PC in high risk population, PSA is commonly used. The early detection of PC is actually carried out ...

Eligibility Criteria

Inclusion

  • Patients suspected with prostate cancer and planned to undergo prostate needle biopsy.
  • Patient with serum PSA test result.
  • Patient willing to provide morning urine sample before biopsy, and willing to provide patient information.
  • Participants without any tumor disease and willing to attend the study by providing morning urine.
  • Male patients aged \>= 18 years.
  • Participants signed informed consent form.

Exclusion

  • Age under 18 years
  • Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record.
  • Patient already received urethral catheterization.
  • Patient with late-stage uremia and need regular dialysis.
  • Patient with urothelial carcinoma or suspected urothelial carcinoma.
  • Suspected PC patient with endocrine therapy without histological results of the prostate.
  • PC patient after any related therapy: endocrine therapy, radiotherapy, radical operation, immunotherapy, chemotherapy, transurethral prostate surgery, cryoablation or other local therapy.

Key Trial Info

Start Date :

January 25 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2023

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04699344

Start Date

January 25 2021

End Date

June 30 2023

Last Update

January 7 2021

Active Locations (1)

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1

Urology Department of Qiluhospital

Jinan, Shandong, China, 250012