Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

NCT02501759 | Terminated Results DMC

• 4 other identifiers: IRB00010086NCI-2015-00930SOL-13142-LMP30CA069533
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

Conditions

Health Status Unknown; Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy

  The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.

  Up to 42 days (6 weeks)

• Sensitivity of MRI-guided Biopsy

  The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

  Up to 2 weeks after diagnostic MRI

• Sensitivity of TRUS-guided Biopsy

  The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

  Up to 2 weeks after MRI-guided biopsy

Study Arms (1)

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

EXPERIMENTAL

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

Procedure: 3 Tesla Magnetic Resonance Imaging; Radiation: Gadodiamide; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Transrectal Biopsy; Procedure: Ultrasound-Guided Prostate Biopsy

Interventions

3 Tesla Magnetic Resonance Imaging PROCEDURE

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Also known as: 3 Tesla MRI, 3T MRI

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

Gadodiamide RADIATION

Given IV

Also known as: DV 7572, Gadolinium-DTPA-BMA, Gd-DTPA-BMA, HSDB 7547, OmniScan

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Also known as: Multiparametric MRI

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

Transrectal Biopsy PROCEDURE

Undergo transrectal MRI-guided biopsy

Also known as: Transrectal Prostate Biopsy

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

Ultrasound-Guided Prostate Biopsy PROCEDURE

Undergo TRUS-guided biopsy

Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen \[PSA\] level and/or abnormal digital rectal examination)
• No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
• Patient willing to undergo scheduled standard of care TRUS guided biopsy
• Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health \& Science University (OHSU)
• Laboratory values and anticoagulation management per consensus guidelines, including:
• International normalized ratio (INR) \>= 1.5
• Platelets \>= 50,000

You may not qualify if:

• Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
• Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
• Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
• Active urinary tract infection
• Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Medical Research Foundation, Oregon: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Since recruitment was very low and funding did not materialize, the study was closed early and insufficient data was collected to analyze and report the outcomes.

Results Point of Contact

• Title: Fegus Coakley
• Organization: OHSU Knight Cancer Institute

coakleyf@ohsu.edu

503-494-2333

Study Officials

• Fergus Coakley

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor and Chair

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: May 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: February 10, 2017
• Last Updated: April 3, 2019
• Results First Posted: April 3, 2019

Record last verified: 2019-03

Locations

US (1)