NCT01613651

Brief Summary

This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_3

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

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 24, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

5.1 years

First QC Date

June 5, 2012

Last Update Submit

September 13, 2017

Conditions

Perioperative/Postoperative ComplicationsProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)

    The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates.

    Within 90 days from prostatectomy

Secondary Outcomes (3)

  • Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0

    Within 90 days post prostatectomy

  • Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency

    Up to 12 months

  • Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0

    Within 90 days from prostatectomy

Study Arms (2)

Arm I (RALP)

EXPERIMENTAL

Patients undergo RALP.

Procedure: robot-assisted laparoscopic surgeryOther: questionnaire administration

Arm II (RALP and placement of pelvic drain)

EXPERIMENTAL

Patients undergo RALP and placement of pelvic drain.

Procedure: robot-assisted laparoscopic surgeryOther: questionnaire administrationOther: intraoperative complication management/prevention

Interventions

robot-assisted laparoscopic surgeryPROCEDURE

Undergo RALP

Arm I (RALP)Arm II (RALP and placement of pelvic drain)
questionnaire administrationOTHER

Ancillary studies

Arm I (RALP)Arm II (RALP and placement of pelvic drain)
intraoperative complication management/preventionOTHER

Undergo placement of pelvic drain

Arm II (RALP and placement of pelvic drain)

Eligibility Criteria

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

You may qualify if:

  • Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
  • Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services

You may not qualify if:

  • Non-compliance
  • Prior radiotherapy to the pelvis or prostate
  • Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon
  • Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
  • Intra-operative injuries (for example: rectal injury)
  • Inadequate hemostasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Postoperative ComplicationsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jonathan Yamzon

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

August 24, 2012

Primary Completion

September 11, 2017

Study Completion

September 11, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)