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Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis

Recruitingn/aAges 18 Years - anyMaleXijing Hospital
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In plain words

What the trial is, and whether it could suit you

Brief Summary: This prospective, multicenter study aims to discover, develop, and validate a plasma exosomal RNA-based signature as a rule-out test for predicting bone metastasis in prostate cancer, using baseline treatment-naรฏve PSMA PET as the gold standard. The study is designed in four sequential phases: Phase 1 (Discovery, n=250): High-throughput sequencing of plasma exosomal RNAs to identify differentially expressed candidate RNAs. Phase 2 (Model Development, n=300): Digital droplet PCR (ddPCR) analysis of candidates in an independent cohort to construct and lock the final multi-RNA predictive signature using appropriate machine learning methods. Phase 3 (Internal Validation, n=300): Independent validation of the locked signature in a consecutive cohort reflecting natural disease prevalence. Phase 4 (External Validation, n=150): Final independent validation in a multi-center c

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging. 2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery). 3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable). Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80ยฐC until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination. 4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection). 5. Patients who provide written informed consent to participate in the study. 6. Age โ‰ฅ18 years. Exclusion Criteria 1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery). 2. Patients whose blood samples were collected after prostate biopsy. 3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer). 4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \<8 mL). 5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.
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What it tests

  • Not listed
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Where

9 sites
The First Hospital of Lanzhou University
Lanzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
Weinan Central Hospital
Weinan, China
Xijing Hospital
Xi'an, China
Shaanxi Provincial People's Hospital
Xi'an, China
Xijing 986 Hospital
Xi'an, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, China
Qinghai University Affiliated Hospital
Xining, China

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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