NCT02138760

Brief Summary

Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this population of men. In this prospective randomized trial multicenter trial the investigators will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared with the addition of either a computer targeted system (UroNav - InVivo corp) to sample suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these areas and systematic biopsy alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

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

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 13, 2014

Last Update Submit

May 14, 2014

Conditions

Prostate Cancer

Keywords

prostate cancerprostate biopsymagnetic resonance imaging guidancedetection ratesperformance

Outcome Measures

Primary Outcomes (1)

  • Prostate cancer detection rate

    Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy

    1 week after biopsy

Secondary Outcomes (1)

  • Clinically significant prostate cancer detection rate

    1 week after biopsy

Other Outcomes (1)

  • Tumor volume

    1 week after biopsy

Study Arms (2)

MRI guided cognitive fusion biopsy

NO INTERVENTION

Men in this arm will undergo MRI followed by systematic biopsy and then additional cognitive (freehand) biopsies of MRI suspicious targets

UroNav fusion biopsy

EXPERIMENTAL

Men in this arm will undergo MRI followed by systematic biopsy and then additional UroNav fusion biopsy of MRI suspicious targets

Procedure: MRI UroNav fusion biopsy

Interventions

MRI UroNav fusion biopsyPROCEDURE
Also known as: UroNav (InVivo corp)
UroNav fusion biopsy

Eligibility Criteria

Age30 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PSA \> 2.5 ng/ml (ages 30-50) or PSA \> 4.0 ages (50-79)
  • Patients with prior negative prostate biopsy
  • Written informed consent
  • Age \> 30

You may not qualify if:

  • Prior diagnosis of prostate cancer
  • Age\> 79
  • No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications)
  • Active urinary tract infection or indwelling catheter
  • Prior pelvic irradiation
  • Prior androgen deprivation hormonal therapy
  • Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI.
  • Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Los Angeles (Sunset)

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Riverside

Riverside, California, 92505, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • David S Finley, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Finley, MD

CONTACT

3237835500David.S.Finley@kp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Robotic Surgery

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations

US(2)