Clinical trial NCT04271527: Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Official title: Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
cognitive fusion targeted biopsy
software-based fusion targeted biopsy
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: 1st hospital of xi'an jiaotong university
name: Qilu Hospital of Shandong University
name: The First Affiliated Hospital of Zhengzhou University
name: Zibo Central Hospital
name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Henan university of CM
name: 2nd hospital of xi'an jiaotong university
name: Peking University First Hospital
name: The University of Hong Kong-Shenzhen Hospital
First posted: 2020-02-17
Enrollment: 626
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The detection rate of clinically significant prostate cancer for targeted biopsy
timeFrame: 5-6 weeks after signing the consent
Secondary outcomes:
measure: The detection rate of any prostate cancer for targeted biopsy
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer for combined biopsy
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of any prostate cancer for combined biopsy
timeFrame: 5-6 weeks after signing the consent
measure: Prostate volume
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4
timeFrame: 5-6 weeks after signing the consent
measure: The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5
timeFrame: 5-6 weeks after signing the consent
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.