Prospective Randomized Trial Comparing Robotic Versus Ope... | NCT01365143

Studies
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

NCT01365143

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Jun 2, 2014Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Prostatic Neoplasms
Adenocarcinoma

Interventions

Robotic Radical Prostatectomy
Open Radical Prostatectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closing due to slow enrollment

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2014

Last Update Posted Date

Jun 2, 2014Estimated

Description Module

Brief Summary

To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Radical Prostatectomy	Active Comparator		Procedure: Open Radical Prostatectomy
Robotic radical prostatectomy	Active Comparator		Procedure: Robotic Radical Prostatectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic Radical Prostatectomy	Procedure	Robotic assisted radical prostatectomy	Robotic radical prostatectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trifecta	Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy	at 2 years

Secondary Outcomes

Measure	Description	Time Frame
Continence	Continent of urine	at 3, 12, and 24 months
Potency	Satisfactory erections	at 3, 12, and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven adenocarcinoma of the prostate
Deemed a surgical candidate for a bilateral nerve bundle preservation
Potent
Continent of urine
Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
Age >18

Exclusion Criteria:

Previous treatment of prostate cancer (radiation, hormones, etc.)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D000230	Adenocarcinoma

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided