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Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV

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ClinicalTrials.gov Identifier: NCT04251546
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer PSA Diagnostic Test: p2PSA ,ultrasonic parameters and transperineal prostate biopsy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational group
Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL
Diagnostic Test: p2PSA ,ultrasonic parameters and transperineal prostate biopsy
p2PSA test(for calculation of PHI), ultrasonic parameters(TPV) and transperineal prostate biopsy for confirmation of prostate cancer




Primary Outcome Measures :
  1. Transrectal ultrasound guided prostate biopsy [ Time Frame: 2019/05/01-2021/05/30 ]
    Perform a transrectal ultrasound-guided prostate biopsy (12 needles) according to a standardized protocol. If a suspicious low-density nodule is found during the ultrasound, biopsy to the nodule can be added. Place the prostate biopsy specimen in a 10% Formalin's specimen bag. The specimens were processed and evaluated by the pathology department of Xinhua Hospital.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study selected patients with suspected prostate cancer in the Department of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from May 2019 to May 2022, and had a PSA test value of 4-10 ng / mL.
Criteria

Inclusion Criteria:

  1. Patient> 45 years of age, with abnormal serum PSA, with or without digital rectal examination (DRE), with indications for prostate biopsy.
  2. Prostate biopsy indications:

(1) DRE found prostate nodules; (2) MRI, TRUS and other examinations found abnormalities; (3) f / tPSA is abnormal or PSAD value is abnormal. 3. Criteria for diagnosis of prostate cancer: The pathological results of transrectal ultrasound-guided prostate biopsy (12 needles), Gleason score is based on the diagnosis of pathology.

Exclusion Criteria:

Incomplete medical history; poor quality of serum samples; bacterial acute prostatitis diagnosed within 3 months before biopsy; 5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy; patient with previous prostate biopsy history.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251546


Contacts
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Contact: Yongjiang Yu, MD. 86-13916241036 yuyongjiang@xinhuamed.com.cn

Locations
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China, Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Guangyu Chen, MD.    +86-1356414407    chenguangyu@xinhuamed.com.cn   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04251546    
Other Study ID Numbers: XH-20-002
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Prostate Cancer
PSA
PHI
ultrasound
TPV
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases