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NCT Number: NCT05761912

Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiomics Ultrasound Urogenital Diseases Urogenital Neoplasms

Age range

55 year and older

Sex eligibility

Male

Study type

Observational

Primary location

170th Xinsong Rd, Minhang District

Shanghai, China

About this study

Researchers plan to develop a diagnostic and prognostic evaluation model for prostate cancer by analyzing abnormal echoes in prostate ultrasound images through radiomics. This model will be used to guide ultrasound radiomics-fusion prostate biopsy, and its accuracy will be compared with that of systematic biopsy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥55 years old.
  • Patients had tPSA/fPSA within 1 month before biopsy.
  • Patients had any of the following indications for prostate biopsy:
  • Suspicious prostate nodules were found by digital rectal examination
  • Suspicious lesions were detected by B-ultrasound or MRI
  • PSA>10ng/ml
  • PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values

Exclusion criteria

  • malignant tumors other than prostate adenocarcinoma indicated by pathology.
  • Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
  • Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc

Treatment and study plan

Targeted biopsy

Diagnostic Test

For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.

Primary outcomes

  1. Positive rate of ultrasound radiomics fusion targeted biopsy

    Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy

    Positive rate of ultrasound radiomics fusion targeted biopsy

  2. Positive rate of systematic biopsy

    Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy

    Positive rate of systematic biopsy

  3. Positive rate of mpMRI cognitive fusion targeted biopsy

    Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy

    Positive rate of mpMRI cognitive fusion targeted biopsy

  4. Ultrasound radiomics parameters

    Time frame: The 30min following the transrectal ultrasonography

    The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer/ITK-SNAP software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.

Secondary outcomes

  1. Gleason's score of positive tissue

    Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy

    Gleason's score of positive tissue from targeted prostate biopsy. Prostate cancer was graded by Gleason score (GS) ranging from 6 to 10. Tumors of GS 6 (3 + 3) are considered low grade (LG), while GS ≥7 are high grade (HG).

  2. PI-RADS score

    Time frame: Within one month prior to prostate biopsy.

    Prostate Imaging Reporting and Data System (PI-RADS) score was obtained according to multiparametric magnetic resonance imaging. PI-RADS is used to standardize interpretation of prostate MRI. Each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer. PI-RADS 1: clinically significant cancer is highly unlikely to be present; PI-RADS 2: clinically significant cancer is unlikely to be present; PI-RADS 3: the presence of clinically significant cancer is equivocal; PI-RADS 4: clinically significant cancer is likely to be present; PI-RADS 5: clinically significant cancer is highly likely to be present.

  3. Incidence of complications

    Time frame: Up to the first month after the targeted biopsy

    Incidence of complications associated with prostate biopsy

Sponsors and collaborators

Lead sponsor

Shanghai Minhang Central Hospital

Other

Collaborators

  • Shanghai Municipal Commission of Health and Family Planning
  • Wu Jieping Medical Foundation

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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