Prostate Cancer
Conditions
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.
Interventions
DEVICEmagnetic resonance imaging
Undergo pelvic MRI
PROCEDUREprostate biopsy
Undergo prostate biopsy
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased detection of clinically significant prostate cancer | Up to 1 year | Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of clinically significant prostate cancer using 3D T2 SPACE | Up to 1 year | Number of patients with positive prostate cancer detection using 3D T2 SPACE |
| Detection of clinically significant prostate cancer using 3D T2 HASTE | Up to 1 year | Number of patients with positive prostate cancer detection using 3D T2 HASTE |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pathology specimen correlation with MRI findings | Up to 1 year | 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. |
Countries
United States
Outcome results
None listed