NCT01764347

Brief Summary

This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

December 21, 2012

Last Update Submit

January 27, 2014

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of times the first biopsy needle is placed within 3.0 mm of the center lesion

    A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

    One month after last patient enrolled is taken off study

  • Number of times the second biopsy needle is placed within 3.0 mm of the center lesion

    A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

    One month after last patient enrolled is take off study

Secondary Outcomes (3)

  • Average distance of the first needle to the center of the lesion

    One month after last patient enrolled is taken off study

  • Average distance of the second needle from the first needle minus 2.0 mm

    One month after last patient enrolled is taken off study

  • Average distance of the third needle from the first needle minus 2.0 mm

    One month after last patient enrolled is taken off study

Study Arms (1)

Diagnostic (MRI-TRUS fusion image-guided biopsy)

EXPERIMENTAL

Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Procedure: therapeutic conventional surgeryProcedure: ultrasound-guided prostate biopsyProcedure: magnetic resonance imaging

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo robotic radical prostatectomy

Diagnostic (MRI-TRUS fusion image-guided biopsy)
ultrasound-guided prostate biopsyPROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

Diagnostic (MRI-TRUS fusion image-guided biopsy)
magnetic resonance imagingPROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (MRI-TRUS fusion image-guided biopsy)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) \>= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
  • Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
  • Subjects must have decided to have their prostate surgically removed

You may not qualify if:

  • Patients who do not give informed consent
  • Patients with extracapsular extension of their prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Osamu Ukimura

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 9, 2013

Study Start

November 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

US(1)