Using blood tests and MRI for diagnosing prostate cancer
A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
This study is testing if a new blood test combined with MRI scans can help doctors better diagnose prostate cancer in men who have signs of the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 808 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT05947188 on ClinicalTrials.gov |
What this trial studies
This trial is a prospective, multicentre diagnostic study aimed at evaluating the early diagnostic capabilities of circulating tumor cells (CTCs) combined with multimodal MRI for prostate cancer. It will enroll 808 men who have a clinical suspicion of prostate cancer based on elevated PSA levels or other abnormal examinations. Participants will undergo prostate biopsy, and CTCs will be detected prior to the biopsy to assess the diagnostic accuracy of the combined methods. The study will analyze various metrics including sensitivity, specificity, and predictive values to determine the effectiveness of this diagnostic approach.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 50 and older with elevated PSA levels and clinical suspicion of prostate cancer.
Not a fit: Patients with a previous diagnosis of prostate cancer or those who cannot tolerate a biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and non-invasive method for diagnosing prostate cancer.
How similar studies have performed: Other studies have shown promise in using circulating tumor cells and advanced imaging techniques for cancer diagnosis, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. No family history of prostate cancer; 2. men ≥ 50 years； 3. tPSA level of 4-10 ng/ml, and fPSA/tPSA\<0.16; 4. tPSA level of \>10 ng/ml； 5. With abnomal mpMRI、PET/CT、TRUS or DRE; 6. fully understand the clinical trial protocol and sign the informed consent; Exclusion Criteria: 1. Not meet all of the inclusion criteria or any single inclusion criteria； 2. previous diagnosis of prostate carcinoma ; 3. symptomatic of acute prostatitis; 4. local anesthetic allergy patients; 5. cannot tolerate prostate biopsy or has contraindication to biopsy; 6. patients judged by the investigator to be unsuitable to participate in the clinical trial;
Where this trial is running
Xi'an
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
Study contacts
- Study coordinator: yang gao
- Email: gaoyangxjtu@126.com
- Phone: 0086-029-85323473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.