Enrolling by invitation NCT06604130
Plasma Exosome RNA to Diagnose Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate cancer screening decision.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial
Overview
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.
Interventions
- Diagnostic test Prostate cancer screening decision
The subjects would receive serum PSA test.
Primary outcome measures
- The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa [Time frame: The time of prostate biopsy and after 6 months follow-up]
Secondary outcome measures (1)
- Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests [Time frame: The time of prostate biopsy and after 6 months follow-up]
Eligibility criteria
Inclusion criteria
- Blood prostate-specific antigen PSA\>4ng/dl;
- Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
- The patient is willing to undergo prostate biopsy.
Exclusion criteria
- Previous diagnosis of prostate cancer through prostate biopsy;
- History of other malignant tumors in the past two years;
- According to the research physician\'s judgment, serious complications may occur and affect the normal conduct of the experiment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 9 centers
- The First Hospital of Lanzhou University — Lanzhou
- General Hospital of Ningxia Medical University — Yinchuan
- Qinghai University Affiliated Hospital — Xining
- Weinan Central Hospital — Weinan
- Shaanxi Provincial People's Hospital — Xi'an
- Xijing 986 Hospital — Xi'an
- Xijing Hospital — Xi'an
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang
- … and 1 more center
Identifiers
NCT: NCT06604130 · KY20242271-C-1 · NSFC(China)