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

NCT04699344 | Unknown

• 1 other identifier: QL-URO-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 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

Prostate Carcinoma

Keywords

diagnosis

Outcome Measures

Primary Outcomes (8)

• Sensitivity of urinalysis by PROUD analysis

  number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer.

  through study completion, an average of 30 months

• Specificity of urinalysis by PROUD analysis

  number of patients "declared negative" with the PROUD test among the patients without cancer.

  through study completion, an average of 30 months

• Identification of the correlation between the level of CNV and the grade (Gleason Score,GS) of the tumor sample

  level of CNV in the urine sample compared with the grade of the tumor confirmed by histopathologic examination.

  through study completion, an average of 30 months

• Identification of the correlation between the level of CNV and the stage (TNM) of the tumor sample.

  through study completion, an average of 30 months

  level of CNV in the urine sample compared with the stage of the tumor confirmed by histopathologic examination.

• Comparison of the sensitivity of the PROUD analysis versus urine PCA3

  number of patients "declared positive" with the PROUD analysis versus patients "declared positive" with the PCA3 test.

  through study completion, an average of 30 months

• Comparison of the specificity of the PROUD analysis versus urine PCA3

  number of patients "declared negative" with the PROUD analysis versus patients " declared negative " with the PCA3 test.

  through study completion, an average of 30 months

• Sensitivity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1)

  number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).

  through study completion, an average of 30 months

• Specificity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).

  number of patients "declared negative" with the PROUD test among the patients without cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).

  through study completion, an average of 30 months

Study Arms (2)

Pre-tissue biopsy patients

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.

Diagnostic Test: The level of CNV

Non-cancer participants

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.

Diagnostic Test: The level of CNV

Interventions

The level of CNV DIAGNOSTIC_TEST

The extracted DNA from morning urine will be analyzed by PROUD to determine the level of CNV.

Also known as: PROUD test of the urine exfoliated cells

Non-cancer participants; Pre-tissue biopsy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with prostate carcinoma or participants in control group from January 2021 to June 2023 in Qilu hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Urology Department of Qiluhospital

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (4)

• Zeng 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 RESULT

• Thuret 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 RESULT

• Hessels 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 RESULT

• Ozdemir 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA from Urine Exfoliated Cells will be analyzed

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zunlin Zhou, MD

  Qiluhospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yueqing Tang, MD

CONTACT

+8618560083899; sdurology@163.com

Zunlin Zhou, MD

CONTACT

+8618560083921; zunlin117@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: January 25, 2021
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)