Prostate Cancer
Conditions
Keywords
prostate cancer, cognitive fusion targeted biopsy, software-based fusion targeted biopsy
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.
Interventions
PROCEDUREcognitive fusion targeted biopsy
A cognitive fusion targeted biopsy
Sponsors
Peking Union Medical College Hospital
1st hospital of xi'an jiaotong university
Qilu Hospital of Shandong University
The First Affiliated Hospital of Zhengzhou University
Zibo Central Hospital
Shandong Provincial Hospital
The First Affiliated Hospital of Henan university of CM
2nd hospital of xi'an jiaotong university
Peking University First Hospital
The University of Hong Kong-Shenzhen Hospital
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The detection rate of clinically significant prostate cancer for targeted biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| The detection rate of clinically significant prostate cancer for combined biopsy | 5-6 weeks after signing the consent | The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples |
| The detection rate of any prostate cancer for combined biopsy | 5-6 weeks after signing the consent | The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples |
| Prostate volume | 5-6 weeks after signing the consent | To measure the prostate volume by ultrasound and MRI |
| The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm | 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. |
| The detection rate of any prostate cancer for targeted biopsy | 5-6 weeks after signing the consent | The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples |
| The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm | 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. |
| The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3 | 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. |
| The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4 | 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. |
| The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5 | 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. |
| The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm | 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. |
Countries
China
Contacts
Primary ContactBiming He, MD
Backup ContactHaifeng Wang, MD
Outcome results
None listed