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Clinical Trials in China / NCT06612047
Recruiting Observational

Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer

NCT06612047 · tracked via the Priya Life Science China tracker
Sponsor
Anhui Provincial Hospital
Phase
Observational
Started
2024-10-08
Last updated
2025-02-11

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Prostate biopsy

Prostate biopsy: All patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results.

Study summary

The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are:

* Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer.
* Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer.

The data of participants was collected prospectively.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) ); 2. The primary prostate cancer has no other cancer history; 3. The 3.0TbpMRI examination was completed, and the images were clear and accessible; 4. The 5.0TbpMRI examination was further completed, and the images were clear and accessible; 5. The patient fully understands the relevant content of the study and voluntarily signs the informed consent. Exclusion Criteria: 1. The patient has contraindications to MRI examination, such as metal plates and heart stents in the body; 2. The patient does not have an indication for prostate biopsy or refuses biopsy; 3. The patient has contraindications to prostate biopsy; 4. 3.0T MRI considers that the patient has multiple lymph node or bone metastases; 5. The patient has undergone other prostatic surgery in the past; 6. The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form.

Primary outcome measure(s)

  • Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. — through study completion, an average of 1 month
    Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, The First Affiliated Hospital of USTC Hefei Anhui Recruiting

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Other trials for the same condition

Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer Recruiting
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy Starting soon
CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer Recruiting
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer Recruiting
Adjuvant Hypofractionated Radiotherapy for Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06612047 on ClinicalTrials.gov ↗ ← All trials in China