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Trial record 15 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

3D Versus Robot Assisted Laparoscopic Prostatectomy.

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ClinicalTrials.gov Identifier: NCT03550040
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Seinajoki Central Hospital
Information provided by (Responsible Party):
Antti Kaipia, Tampere University Hospital

Brief Summary:
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radical prostatectomy Not Applicable

Detailed Description:
The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Robot assisted prostatectomy.
Intervention: radical prostatectomy
Procedure: Radical prostatectomy
Surgical removal of the prostate
Other Name: Total prostatectomy

Experimental: 3D laparoscopic prostatectomy
Intervention: radical prostatectomy
Procedure: Radical prostatectomy
Surgical removal of the prostate
Other Name: Total prostatectomy




Primary Outcome Measures :
  1. Urinary continence [ Time Frame: 12 months ]
    Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure.


Secondary Outcome Measures :
  1. Erectile function [ Time Frame: 12 months ]
    International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.

  2. Prostate specific antigen [ Time Frame: 12 months ]
    Post operative prostate specific antigen levels.

  3. Evaluation of surgical margins at pathologic examination. [ Time Frame: up to 12 months ]
    The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination.


Other Outcome Measures:
  1. costs of treatment [ Time Frame: 12 months ]
    Direct and indirect treatment related costs.



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Ages Eligible for Study:   34 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Localized prostate cancer undergoing radical prostatectomy
  • Patient has to understand and be able to write and read Finnish language
  • No prior head injury, dementia or Parkinson's disease
  • No concomitant malignant illness
  • Life expectancy of at least 10 years
  • 35-74 years of age

Exclusion Criteria:

  • Locally advanced prostate cancer (T4)
  • Suspicion or documented metastases (M1)
  • Serum PSA > 20 ng/ml
  • Prior laparoscopic hernia surgery employing non resorbable mesh
  • Prior pelvic irradiation or major surgery
  • Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550040


Contacts
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Contact: Antti Kaipia, M.D., Ph.D. 503130454 ext +358 antti.kaipia@pshp.fi
Contact: Jarno Riikonen, M.Dd., Ph.D. 408430957 ext +358 jarno.riikonen@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Antti Kaipia, M.D., Ph.D.    503130454 ext +358    antti.kaipia@pshp.fi   
Contact: Jarno Riikonen, M.D., Ph.D.    408430957 ext +358    jarno.riikonen@pshp.fi   
Sub-Investigator: Juha Koskimäki, M.D., Ph.D.         
Sub-Investigator: Tomi Pakarainen, M.D., Ph.D.         
Sub-Investigator: Jarno Riikonen, M.D., Ph.D.         
Sponsors and Collaborators
Tampere University Hospital
Seinajoki Central Hospital
Investigators
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Principal Investigator: Antti Kaipia, M.D., Ph.D. chief, dept of urology

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Responsible Party: Antti Kaipia, Chief physician, department of urology, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03550040     History of Changes
Other Study ID Numbers: 18005
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antti Kaipia, Tampere University Hospital:
radical prostatectomy
laparoscopic prostatectomy
robot assisted prostatectomy