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Cohort study of novel prostate biomarkers for the early diagnosis of prostate cancer

Novel prostate biomarkers for the early diagnosis of prostate cancer: a prospective, multicenter clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041553
Enrollment
Unknown
Registered
2020-12-28
Start date
2020-12-29
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

prostate cancer

Interventions

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Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Men aged below 85 years. 2. Men with suspected prostate cancer as determined by elevated serum PSA level, positive digital rectum examination, and/or positive findings from imaging examinations, who plan to undergo prostate biopsy to confirm the diagnosis. 3. Men who are well informed of the current diagnosis and treatment options and are willing to participate in this trial.

Exclusion criteria

Exclusion criteria: A patient may not enter the study if ANY of the following applies: 1. Any other previous or current malignancies diagnosed within 5 years; 2. Prior transurethral enucleation or resection of the prostate; 3. Prior history of prostate biopsy for suspected prostate cancer; 4. Metastasis suggested by imaging examination; 5. Sustained use of anticoagulation and antiplatelet drugs; 6. Any other severe systemic diseases; 7. Participation in other trials which are ongoing or have been completed within 12 months; 8. Any contraindications for prostate biopsy; 9. Any other conditions, which, in the judgment of the investigators, are likely to interfere with the assessment or compliance associated with this trial.

Design outcomes

Primary

MeasureTime frame
diagnostic performance;

Countries

China

Contacts

Public ContactShancheng Ren

Shanghai Changhai Hospital

renshancheng@gmail.com+86 13917793885

Outcome results

None listed

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