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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive targeted biopsy | Experimental | a cognitive fusion targeted biopsy combined with a systematic biopsy |
|
| software targeted biopsy | Active Comparator | software-based fusion targeted biopsy combined with a systematic biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive fusion targeted biopsy | Procedure | A cognitive fusion targeted biopsy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biming He, MD | Contact | +8615502139410 | 190589109@qq.com | |
| Haifeng Wang, MD | Contact | +8613681750891 | 446720864@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang, MD | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33550242 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| The First Affiliated Hospital of Zhengzhou University |
| OTHER |
| Zibo Central Hospital | OTHER_GOV |
| Shandong Provincial Hospital | OTHER_GOV |
| The First Affiliated Hospital of Henan university of CM | UNKNOWN |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Peking University First Hospital | OTHER |
| The University of Hong Kong-Shenzhen Hospital | OTHER |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |