MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Novel Screening MRI for the Detection of Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131207
• Other study ID #: CASE6813
• Secondary ID: NCI-2014-00822CA
• Status: Terminated
• Phase: N/A
• First received: April 17, 2014
• Last updated: December 19, 2017
• Start date: September 10, 2014
• Est. completion date: December 8, 2017

Study information

• Verified date: December 2017
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

Description:

PRIMARY OBJECTIVES:

I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).

SECONDARY OBJECTIVES:

I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.

IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.

V. Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.

OUTLINE:

Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Abnormal prostate-specific antigen (PSA) blood test

• > 2.5 ng/mL for men < 50 years (yrs) of age

• > 3.5 ng/mL for men < 60 yrs of age

• > 4.5 ng/mL for men < 70 yrs of age

• Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)

• Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer

Exclusion Criteria:

• Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer

• Contraindications to TRUS/prostate biopsy (BX)

• Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder

• Active urinary tract infection

• Acute painful perianal disorder (i.e. rectal abscess)

• Contraindications to MRI

• Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips

• The presence of an implanted pacemaker or implanted defibrillator device

• Patients with contraindications for MRI due to embedded foreign metallic objects:

bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient

• Implanted medical device not described above that is not MRI-compatible

• Known history of claustrophobia

• Individuals with a short life expectancy (< 10 years)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• magnetic resonance imaging
Undergo pelvic MRI

Procedure:
• prostate biopsy
Undergo prostate biopsy

Locations

Country	Name	City	State
United States	University Hospitals, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pathology specimen correlation with MRI findings	Statistical correlation of MRI findings with final pathology specimens in those patients who elect to be treated with radical prostatectomy for treatment of their biopsy detected prostate cancer with 0 showing no correlation and 1 showing perfect correlation between findings.	Up to 1 year
Primary	Increased detection of clinically significant prostate cancer	Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%	Up to 1 year
Secondary	Detection of clinically significant prostate cancer using 3D T2 SPACE	Number of patients with positive prostate cancer detection using 3D T2 SPACE	Up to 1 year
Secondary	Detection of clinically significant prostate cancer using 3D T2 HASTE	Number of patients with positive prostate cancer detection using 3D T2 HASTE	Up to 1 year