Clinical trial · Observational
A Prospective, Single-centre，Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis
A Prospective, Single-centre,Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis
- 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)
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 specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case, even causing missed diagnosis of some high risk PC, and over diagnosis of PC is not rare. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. Our previous study has proved that PROstate cancer Urine Detector (PROUD), which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in PC diagnosis hasn't been assessed yet and the accuracy of PROUD in detecting PC need to be validated. We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The level of CNV | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pre-tissue biopsy patients
- description
- Pre-tissue biopsy patients with suspected prostate carcinoma will be the experimental group to determine the sensitivity and specificity of PROUD analysis, the result will be compared with histological results and PCA3 test.
- interventionNames
- Diagnostic Test: The level of CNV
- label
- Non-cancer participants
- description
- Patients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of PROUD analysis.
- interventionNames
- Diagnostic Test: The level of CNV
Primary outcomes (8)
- measure
- Sensitivity of urinalysis by PROUD analysis
- timeFrame
- through study completion, an average of 30 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (4)
- RESULTZeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9. PMID 33037018
- RESULTThuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40. doi: 10.1038/sj.bjc.6602311. PMID 15655554
- RESULTHessels D, Schalken JA. The use of PCA3 in the diagnosis of prostate cancer. Nat Rev Urol. 2009 May;6(5):255-61. doi: 10.1038/nrurol.2009.40. PMID 19424173
- RESULTOzdemir TR, Simsir A, Onay H, Cureklibatir I, Ozkinay F, Akin H. Whole-genome gene expression analysis in urine samples of patients with prostate cancer and benign prostate hyperplasia. Urol Oncol. 2017 Oct;35(10):607.e15-607.e24. doi: 10.1016/j.urolonc.2017.05.020. Epub 2017 Jun 21. PMID 28647394