Prostate Cancer
Conditions
Brief summary
This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery
Detailed description
PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation data during RALP to guide us in deciding whether and how the mechanical manipulation of the TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo TRUS during RALP. After the completion of study treatment, patients are followed up at 7 days.
Interventions
PROCEDUREultrasound imaging
Undergo transrectal ultrasound
PROCEDURErobot-assisted laparoscopic surgery
Undergo robotic-assisted laparoscopic prostatectomy
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
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing Robotic Assisted Laparoscopic Prostatectomy
Exclusion criteria
* Known or discovered rectal pathology * Bleeding hemorrhoids * Rectal stenosis * Any prior rectal surgeries * Prior rectal radiation * Any known rectal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications. | 7 days post-RALP |
Countries
United States
Outcome results
None listed