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

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04251546
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 32.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	Phase
Prostate Cancer; PSA	Diagnostic Test: p2PSA; Diagnostic Test: Ultrasonic parameters; Diagnostic Test: Transperineal prostate biopsy

Study Design

• Study Type: Observational
• Anticipated 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: Jan 4, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational group Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL	Diagnostic Test: p2PSA; p2PSA test(for calculation of PHI); Diagnostic Test: Ultrasonic parameters; Ultrasonic parameters(TPV); Diagnostic Test: Transperineal prostate biopsy; Transperineal prostate biopsy for confirmation of prostate cancer or benign disease

Outcome Measures

Primary Outcome Measures

1. Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases [2019/05/01-2021/05/30]

   Pathological confirmed diagnosis by 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient> 45 years of age

2. Abnormal serum PSA

3. Prostate nodules found by DRE

4. Abnormal MRI or TRUS finding

Exclusion Criteria:

1. Incomplete medical history

2. Poor quality of serum samples

3. Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy

5.Previous prostate biopsy history.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04251546
• Other Study ID Numbers: XH-20-002
• First Posted: Feb 5, 2020
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• 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: Prostatic Neoplasms

Study Results

No Results Posted as of May 6, 2022