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NCT Number: NCT04271527

Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

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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 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location status: Recruiting

About this study

This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18
  • PSA increase to 4-20 ng/ml and/or abnormal DRE;
  • Sign the informed consent

Exclusion criteria

  • Have acute or chronic prostatitis
  • Contraindications to prostate biopsy
  • Contraindications to MRI
  • Other reasons that not suitable for this trial

Treatment and study plan

cognitive fusion targeted biopsy

Procedure

A cognitive fusion targeted biopsy

Primary outcomes

  1. The detection rate of clinically significant prostate cancer for targeted biopsy

    Time frame: 5-6 weeks after signing the consent

    The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples

Secondary outcomes

  1. The detection rate of any prostate cancer for targeted biopsy

    Time frame: 5-6 weeks after signing the consent

    The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples

  2. The detection rate of clinically significant prostate cancer for combined biopsy

    Time frame: 5-6 weeks after signing the consent

    The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples

  3. The detection rate of any prostate cancer for combined biopsy

    Time frame: 5-6 weeks after signing the consent

    The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples

  4. Prostate volume

    Time frame: 5-6 weeks after signing the consent

    To measure the prostate volume by ultrasound and MRI

  5. The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with maximum diameter <0.5cm, detected ISUP grade group>=2 cancers by targeted biopsy only.

  6. The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm, detected ISUP grade group>=2 cancers by targeted biopsy only.

  7. The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with maximum diameter >1.0 cm, detected ISUP grade group>=2 cancers by targeted biopsy only.

  8. The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with PI-RADS 3, detected ISUP grade group>=2 cancers by targeted biopsy only.

  9. The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with PI-RADS 4, detected ISUP grade group>=2 cancers by targeted biopsy only.

  10. The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5

    Time frame: 5-6 weeks after signing the consent

    Proportion of separate suspicious lesion with PI-RADS 5, detected ISUP grade group>=2 cancers by targeted biopsy only.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Qilu Hospital of Shandong University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Shandong Provincial Hospital
  • The First Affiliated Hospital of Henan university of CM
  • The First Affiliated Hospital of Zhengzhou University
  • The University of Hong Kong-Shenzhen Hospital
  • Zibo Central Hospital

Registry information

Official study title

Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2020
Registry last updated
Aug 16, 2024

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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