Clinical trial NCT02131207: MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
Official title: Novel Screening MRI for the Detection of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-06
Enrollment: 139
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Increased detection of clinically significant prostate cancer
timeFrame: Up to 1 year
Secondary outcomes:
measure: Detection of clinically significant prostate cancer using 3D T2 SPACE
timeFrame: Up to 1 year
measure: Detection of clinically significant prostate cancer using 3D T2 HASTE
timeFrame: Up to 1 year
Other outcomes:
measure: Pathology specimen correlation with MRI findings
timeFrame: Up to 1 year
Locations:
city: Cleveland
country: United States
facility: University Hospitals, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Robert Abouassaly
role: PRINCIPAL_INVESTIGATOR
References: