NCT01365143

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.

Trial Health

57
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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.8 years

First QC Date

May 26, 2011

Last Update Submit

May 30, 2014

Conditions

Prostatic NeoplasmsAdenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Trifecta

    Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy

    at 2 years

Secondary Outcomes (8)

  • Continence

    at 3, 12, and 24 months

  • Potency

    at 3, 12, and 24 months

  • Free from biochemical recurrence

    at 3, 12, and 24 months

  • Acute complications

    Within 30 days of surgery

  • Long-term complication

    >30 days

  • +3 more secondary outcomes

Study Arms (2)

Open Radical Prostatectomy

ACTIVE COMPARATOR
Procedure: Open Radical Prostatectomy

Robotic radical prostatectomy

ACTIVE COMPARATOR
Procedure: Robotic Radical Prostatectomy

Interventions

Robotic Radical ProstatectomyPROCEDURE

Robotic assisted radical prostatectomy

Robotic radical prostatectomy
Open Radical ProstatectomyPROCEDURE

Open radical prostatectomy

Open Radical Prostatectomy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

US(1)