Trial document

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DRKS-ID: DRKS00007138

Trial Description

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Title

Randomized, multicenter study comparing robot-assisted and conventional laparoscopic radical prostatectomy

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Trial Acronym

LAP-01

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URL of the Trial

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Brief Summary in Lay Language

The objective of the study is the comparison of two surgical techniques for localized prostate cancer (robot-assisted versus non-robot-assisted). Bring the robot-assisted method benefits for the patient. Analyzed are men with localized prostate cancer.

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Brief Summary in Scientific Language

Robot-Assisted Laparoscopic Radical Prostatectomy compared to conventional laparoscopic radical prostatectomy in terms of functional, clinical and oncological parameters and quality of life and patient satisfaction.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00007138
Date of Registration in DRKS: 2014/11/13
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 079-12-05032012, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig

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Secondary IDs

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Health Condition or Problem studied

ICD10: C61 - Malignant neoplasm of prostate

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Interventions/Observational Groups

Arm 1: conventional laparoscopic radical prostatectomy
Arm 2: robot-assisted laparoscopic radical prostatectomy

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject
Control: Active control
Purpose: Other
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

continence 3 months postoperative (ICIQ=Urinary Incontinence Form, pads, diary)

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Secondary Outcome

- Continence (ICIQ-SF): 1, 3, 6, 12 months p.o.
- Continence (Pads-per day): 1, 6, 12 months p.o.
- Erectile function (IIEF-5): 3, 6, 12 months p.o.
- Quality of life (EORTC QLQ-C30): 1, 3, 6, 12 months p.o.
- Anxiety and depression (HADS): 1, 3, 6, 12 months p.o.
- Satisfaction: 1, 3, 6, 12 months p.o.
- PSA: 3, 6, 12, 24, 36

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Klinik für Urolgie, Düsseldorf
University Medical Center Klinik für Urologie, Heidelberg
Medical Center Klinik für Urologie, Dortmund

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2014/11/17
Target Sample Size: 782
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Male
Minimum Age: 18 Years
Maximum Age: 75 Years

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Additional Inclusion Criteria

- Histologically confirmed prostate cancer (diagnosis)
- Indication for primary-curative radical prostatectomy
- Patients aged ≤ 75 years (at the time of surgery)

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Exclusion Criteria

- Obese patients with a BMI> 35
- Currently present severe concomitant disease (eg,
Liver cirrhosis, secondary malignancy or recurrence of any kind)
- Tumor stage: T4
- Previous malignancy (≤ 3 years before inclusion in this study)
- Neoadjuvant therapy (≤ 3 months prior to inclusion in this study)
- Immune Compromised Patients
- Intermittent self-catheterization (in the year prior consent)
- The following treatments in the past 3 months: Operations at Sigma, extensive Hämorrhoidalresektion, Transurethral needle ablation of the prostate (TUNA), osteosynthesis supplies the pelvic area, salvage prostatectomy
- Patients with chronic urinary tract infection (proven more than 5 antibiotic-requiring infection episodes in last year)
- Requiring dialysis patients

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Addresses

Primary Sponsor
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- Universität Leipzig
- Ritterstraße 26
- 04109 Leipzig
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Universitätsklinikum LeipzigKlinik und Poliklinik für Urologie
- Ms. Dr. Sigrun Holze
- Liebigstr. 20
- 04103 Leipzig
- Germany
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- Telephone: 03419717600
- Fax: [---]*
- E-mail: LAP-01 at uniklinik-leipzig.de
- URL: [---]*
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Contact for Public Queries
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- Universitätsklinikum LeipzigKlinik und Poliklinik für Urologie
- Ms. Dr. Sigrun Holze
- Liebigstr. 20
- 04103 Leipzig
- Germany
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- Telephone: 03419717600
- Fax: [---]*
- E-mail: LAP-01 at uniklinik-leipzig.de
- URL: [---]*
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Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)
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- Deutsche Krebshilfe e.V.
- Buschstr. 32
- 53113 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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Additional Trial Attributes

Urological disease prostate cancer
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Study recommendations
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German director of clinical investigation
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- Universitätsklinikum Leipzig, Klinik und Poliklinik für Urologie
- Mr. Prof. Dr. med. Jens-Uwe Stolzenburg
- Leipzig
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Further contact
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- [---]*
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Function of contact [---]*
Non-interventional study [---]*
Stage localized
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Onset of therapy [---]*
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* This entry means the parameter is not applicable or has not been set.