Prostate Cancer
Conditions
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
Detailed description
PRIMARY OBJECTIVES: I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens. OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Interventions
PROCEDUREtherapeutic conventional surgery
Undergo robotic radical prostatectomy
PROCEDUREultrasound-guided prostate biopsy
Undergo MRI-TRUS fusion image-guided prostate biopsy
PROCEDUREmagnetic resonance imaging
Undergo MRI-TRUS fusion image-guided prostate biopsy
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients who do not give informed consent * Patients with extracapsular extension of their prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of times the first biopsy needle is placed within 3.0 mm of the center lesion | One month after last patient enrolled is taken off study | 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). |
| Number of times the second biopsy needle is placed within 3.0 mm of the center lesion | One month after last patient enrolled is take off study | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average distance of the first needle to the center of the lesion | One month after last patient enrolled is taken off study | A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated. |
| Average distance of the second needle from the first needle minus 2.0 mm | One month after last patient enrolled is taken off study | A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion. |
| Average distance of the third needle from the first needle minus 2.0 mm | One month after last patient enrolled is taken off study | A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion. |
Countries
United States
Outcome results
None listed