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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: cognitive fusion targeted biopsy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 602
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biming He, MD; Phone Number: +8615502139410; Email: 190589109@qq.com
• Study Contact Backup: Name: Haifeng Wang, MD; Phone Number: +8613681750891; Email: 446720864@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine
      • Contact: Biming He, MD; Phone Number: +8615502139410; Email: 190589109@qq.com
      • Contact: Haifeng Wang, MD; Phone Number: +8613681750891; Email: 446720864@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cognitive targeted biopsy; a cognitive fusion targeted biopsy combined with a systematic biopsy	Procedure: cognitive fusion targeted biopsy; A cognitive fusion targeted biopsy
Active Comparator: software targeted biopsy; software-based fusion targeted biopsy combined with a systematic biopsy	Procedure: cognitive fusion targeted biopsy; A cognitive fusion targeted biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection rate of clinically significant prostate cancer for targeted biopsy	The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples	5-6 weeks after signing the consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection rate of any prostate cancer for targeted biopsy	The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer for combined biopsy	The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples	5-6 weeks after signing the consent
The detection rate of any prostate cancer for combined biopsy	The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples	5-6 weeks after signing the consent
Prostate volume	To measure the prostate volume by ultrasound and MRI	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm	Proportion of separate suspicious lesion with maximum diameter <0.5cm, detected ISUP grade group>=2 cancers by targeted biopsy only.	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm	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.	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm	Proportion of separate suspicious lesion with maximum diameter >1.0 cm, detected ISUP grade group>=2 cancers by targeted biopsy only.	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3	Proportion of separate suspicious lesion with PI-RADS 3, detected ISUP grade group>=2 cancers by targeted biopsy only.	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4	Proportion of separate suspicious lesion with PI-RADS 4, detected ISUP grade group>=2 cancers by targeted biopsy only.	5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5	Proportion of separate suspicious lesion with PI-RADS 5, detected ISUP grade group>=2 cancers by targeted biopsy only.	5-6 weeks after signing the consent

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Peking Union Medical College Hospital; Qilu Hospital of Shandong University; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Zibo Central Hospital; 1st hospital of xi'an jiaotong university; The First Affiliated Hospital of Henan university of CM
• Investigators: Principal Investigator: Haifeng Wang, MD, Shanghai East Hospital,Tongji University School of Medicine

Publications and helpful links

General Publications

• He B, Li R, Li D, Huang L, Wen X, Yang G, Wang H. Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy. BMJ Open. 2021 Feb 5;11(2):e041427. doi: 10.1136/bmjopen-2020-041427.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 14, 2025

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; cognitive fusion targeted biopsy; software-based fusion targeted biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CSTB-2019-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No