NCT01495130

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

November 29, 2011

Last Update Submit

January 27, 2014

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.

    7 days post-RALP

Study Arms (1)

Diagnostic (TRUS)

EXPERIMENTAL

Patients undergo TRUS during RALP.

Procedure: ultrasound imagingProcedure: robot-assisted laparoscopic surgery

Interventions

ultrasound imagingPROCEDURE

Undergo transrectal ultrasound

Also known as: ultrasonography, ultrasound, ultrasound test
Diagnostic (TRUS)
robot-assisted laparoscopic surgeryPROCEDURE

Undergo robotic-assisted laparoscopic prostatectomy

Diagnostic (TRUS)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing Robotic Assisted Laparoscopic Prostatectomy

You may not qualify if:

  • Known or discovered rectal pathology
  • Bleeding hemorrhoids
  • Rectal stenosis
  • Any prior rectal surgeries
  • Prior rectal radiation
  • Any known rectal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Osamu Ukimura

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 19, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

US(1)