NCT02079155

Brief Summary

This randomized clinical trial compares a recently developed technique, called robotic laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS technique, all instruments are inserted through a single incision. R-LESS RP is less invasive than RALP and may leave a smaller scar and cause less pain.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
withdrawn

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

June 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

3.6 years

First QC Date

March 3, 2014

Last Update Submit

January 20, 2016

Conditions

Stage I Prostate CancerStage IIA Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Mean pain score, evaluated with the visual analog pain score (VAPS)

    Compared using the Mann-Whitney U test as appropriate.

    Up to 1 year

  • Mean analgesic consumption, obtained from medical charts and reported as units of parenteral morphine equivalents (mg)

    Compared using the Mann-Whitney U test as appropriate.

    Up to 1 month

Secondary Outcomes (14)

  • Time to oral intake

    Up to 1 year

  • Time to resume ambulation

    Up to 1 year

  • Length of hospital stay, counted in whole days from the day of surgery to the day of discharge

    Up to 3 days

  • Operative time, defined as time elapsed from skin incision to placement of the final skin suture

    Day 1

  • Estimated blood loss during surgery

    Day 1

  • +9 more secondary outcomes

Study Arms (2)

Arm I (RALP)

ACTIVE COMPARATOR

Patients undergo standard RALP.

Procedure: robot-assisted laparoscopic surgeryOther: laboratory biomarker analysisOther: quality-of-life assessmentOther: questionnaire administration

Arm II (R-LESS RP)

EXPERIMENTAL

Patients undergo R-LESS RP.

Procedure: robot-assisted laparoscopic surgeryOther: laboratory biomarker analysisOther: quality-of-life assessmentOther: questionnaire administration

Interventions

robot-assisted laparoscopic surgeryPROCEDURE

Undergo RALP

Arm I (RALP)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (RALP)Arm II (R-LESS RP)
quality-of-life assessmentOTHER

Ancillary studies

Also known as: quality of life assessment
Arm I (RALP)Arm II (R-LESS RP)
questionnaire administrationOTHER

Ancillary studies

Arm I (RALP)Arm II (R-LESS RP)

Eligibility Criteria

Age35 Years - 72 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a or T2b prostate cancer
  • Judged by the study doctor to be a suitable candidate for a radical prostatectomy
  • Serum prostate specific antigen equal to or less than 10 ng/mL
  • Gleason score equal to or less than 7
  • Life expectancy greater than 10 years
  • Prostate size on trans-rectal ultrasound (TRUS) measurement less than 50 grams
  • Favorable operative risk defined as American Society of Anesthesiology Score (ASA score) =\< 3
  • Ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent

You may not qualify if:

  • Patients with any prior pelvic surgery
  • Patients with prior history of pelvic fractures or hip replacement
  • Large pelvic or intra-abdominal masses
  • Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)
  • Poor surgical risk (defined as American Society of Anesthesiology Score \> 3)
  • Active infection
  • Uncorrected coagulopathy
  • Body mass index equal to or greater than 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jihad Kaouk

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

June 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 22, 2016

Record last verified: 2016-01