Blood exosomal RNA test to rule out prostate cancer spread to bone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, four‑phase effort to discover and validate a plasma exosomal RNA signature that could rule out bone metastasis. Phase 1 (n=250) uses high‑throughput sequencing to identify candidate exosomal RNAs, and Phase 2 (n=300) uses ddPCR and machine‑learning methods to build and lock a multi‑RNA predictive model. Phase 3 (n=300) performs independent internal validation in a consecutive cohort reflecting natural disease prevalence, and Phase 4 (n=150) performs external validation across multiple centers enriched for bone metastasis. Baseline treatment‑naïve PSMA PET imaging is used as the reference standard, and blood is collected prior to any prostate biopsy or treatment to avoid confounding.

Why it matters

Who can join: the full rules

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 -80°C 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 ≥18 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.

Where it's running

• The First Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting
• General Hospital of Ningxia Medical University
  Yinchuan, Ningxia, China Recruiting
• Weinan Central Hospital
  Weinan, Shaanxi, China Recruiting
• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting
• Shaanxi Provincial People's Hospital
  Xi'an, Shaanxi, China Recruiting
• Xijing 986 Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Jianhua Jiao, MD.
• Email: 1531769428@qq.com
• Phone: +86 18700919857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.