NCT04124107

Brief Summary

This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

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

October 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 10, 2019

Last Update Submit

October 10, 2019

Conditions

Prostate Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Detection rate of prostate cancer

    Detection rate of prostate cancer

    30 days post biopsy

Secondary Outcomes (3)

  • Detection rates of clinically significant PCa and clinically insignificant prostate cancer

    30 days post biopsy

  • Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology

    90 days post biopsy

  • Optimal cut-off uptake value on PET/MRI for prostate cancer detection

    30 days post-biopsy

Study Arms (1)

Prostate biopsy with 68Ga-PSMA PET/MRI

EXPERIMENTAL

Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI

Device: multiparametric MRI and 68Ga-PSMA PET/MRIProcedure: Prostate biopsy

Interventions

multiparametric MRI and 68Ga-PSMA PET/MRIDEVICE

All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination

Prostate biopsy with 68Ga-PSMA PET/MRI
Prostate biopsyPROCEDURE

Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy

Prostate biopsy with 68Ga-PSMA PET/MRI

Eligibility Criteria

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

You may qualify if:

  • Men more than 18 years old with clinical suspicion of prostate cancer;
  • Serum prostate-specific antigen (PSA) \> 4 ng/ml within the previous 3 months;
  • PI-RADS score no more than 3 or normal mpMRI of prostate;
  • Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
  • no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
  • Able to provide written informed consent.

You may not qualify if:

  • Prior prostate biopsy or prostate surgery;
  • Prior treatment for prostate cancer;
  • Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
  • Contraindication to prostate biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hongqian Guo, PhD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY CHAIR

Central Study Contacts

Hongqian Guo, PhD

CONTACT

8613605171690dr.ghq@nju.edu.cn

Jie Gao, Bachelor

CONTACT

8613951784909medgaojie@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 11, 2019

Study Start

December 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

October 14, 2019

Record last verified: 2019-10