Plasma Exosome RNA to Diagnose Prostate Cancer (exo-PRECISE)

Air Force Military Medical University of People's Liberation Army

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Prostate cancer screening decision

Study type: Interventional

Funder types: Other

Identifiers

NCT06604130

NSFC(China) (Other Grant/Funding Number)

KY20242271-C-1

Details and patient eligibility

About

The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.

Enrollment: 1,600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Blood prostate-specific antigen PSA>4ng/dl;
2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
3. The patient is willing to undergo prostate biopsy.

Exclusion criteria

1. Previous diagnosis of prostate cancer through prostate biopsy;
2. History of other malignant tumors in the past two years;
3. According to the research physician's judgment, serious complications may occur and affect the normal conduct of the experiment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,600 participants in 1 patient group

The experimental arm receiving diagnosis from serum RNA combination

Experimental group

Treatment:

Diagnostic Test: Prostate cancer screening decision