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Investigating blood and urine bacteria in patients with uncertain PSA (prostate-specific antigen) levels

Study on serum and urine microbiota in patients with PSA in the gray zone

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14665000
Enrollment
200
Registered
2024-12-17
Start date
2023-11-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with an outpatient diagnosis of elevated PSA Signs and Symptoms

Interventions

1. Sample collection and processing This study is approved by the Ethics Committee of Jiangnan University Medical Center (2023-Y-168). We will collect patients with elevated PSA in the Urology Departm
2. Exclude patients who have used antibiotics in the past 3 months
3. Exclude patients with urinary tract infection
4. Exclude other tumor patients
5. Patients who dropped out of the study will be excluded. Specific sample collection and treatment methods: After standardized disinfection of the urethral opening, midstream urine samples will be c

Sponsors

Jiangnan University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients with an outpatient diagnosis of elevated PSA 2. Patients are between 40 and 95 years old

Exclusion criteria

Exclusion criteria: 1. Patients with retested PSA values outside 4-10ng/ml range after admission were excluded; 2. Patients who had used antibiotics in the past 3 months were excluded; 3. Patients with urinary tract infection were excluded; 4. Patients with other tumors were excluded; 5. Patients who dropped out of the study were excluded.

Design outcomes

Primary

MeasureTime frame
PSA is measured in the early morning of the day after admission. Midstream specimen of urine was collected in the morning, while blood samples were collected before treatment. They will be measured using 5r16S, OLINK and Non-target metabolite sequencing.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

China

Contacts

Public Contactyang shen
youngshen@stu.njmu.edu.cn+86 13456989315

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026