NCT04271527

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
626

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
4 years until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2025

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

February 13, 2020

Last Update Submit

August 14, 2024

Conditions

Prostate Cancer

Keywords

prostate cancercognitive fusion targeted biopsysoftware-based fusion targeted biopsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • The detection rate of any prostate cancer for targeted biopsy

    5-6 weeks after signing the consent

  • The detection rate of clinically significant prostate cancer for combined biopsy

    5-6 weeks after signing the consent

  • The detection rate of any prostate cancer for combined biopsy

    5-6 weeks after signing the consent

  • Prostate volume

    5-6 weeks after signing the consent

  • The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm

    5-6 weeks after signing the consent

  • +5 more secondary outcomes

Study Arms (2)

cognitive targeted biopsy

EXPERIMENTAL

a cognitive fusion targeted biopsy combined with a systematic biopsy

Procedure: cognitive fusion targeted biopsy

software targeted biopsy

ACTIVE COMPARATOR

software-based fusion targeted biopsy combined with a systematic biopsy

Procedure: cognitive fusion targeted biopsy

Interventions

cognitive fusion targeted biopsyPROCEDURE

A cognitive fusion targeted biopsy

cognitive targeted biopsysoftware targeted biopsy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • PSA increase to 4-20 ng/ml and/or abnormal DRE;
  • Sign the informed consent

You may not qualify if:

  • Have acute or chronic prostatitis
  • Contraindications to prostate biopsy
  • Contraindications to MRI
  • Other reasons that not suitable for this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33550242DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Haifeng Wang, MD

    Shanghai East Hospital,Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Biming He, MD

CONTACT

+8615502139410190589109@qq.com

Haifeng Wang, MD

CONTACT

+8613681750891446720864@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

February 20, 2024

Primary Completion

April 1, 2025

Study Completion

May 14, 2025

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)