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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04271527
• Other study ID #: CSTB-2019-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 14, 2025

Study information

• Verified date: February 2024
• Source: Shanghai East Hospital
• Contact: Biming He, MD
• Phone: +8615502139410
• Email: 190589109[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 602
• Est. completion date: March 14, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• cognitive fusion targeted biopsy
A cognitive fusion targeted biopsy

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Shanghai East Hospital	1st hospital of xi'an jiaotong university, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, Shandong Provincial Hospital, The First Affiliated Hospital of Henan university of CM, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Prostate volume	To measure the prostate volume by ultrasound and MRI	5-6 weeks after signing the consent
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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