Prospective Study to Compare a Limited Versus Extended Pe... | NCT01555086

Studies
Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

NCT01555086

Sponsor

Association of Urologic Oncology (AUO)

Status

Unknown status

Last Update Posted

Jan 24, 2017Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Limited pelvic Lymphadenectomy
Extended pelvic Lymphadenectomy

Countries

Germany

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

ID	Type	Description	Link
DRKS00003256	Registry Identifier	DRKS

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2017Estimated

Completion Date

Not provided

First Submitted Date

Mar 13, 2012

First Submission Date that Met QC Criteria

Mar 14, 2012

First Posted Date

Mar 15, 2012Estimated

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

Jan 23, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study examines Limited versus extended pelvic lymphadenectomy.

Detailed Description

This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.

Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limited pelvic Lymphadenectomy	Experimental		Procedure: Limited pelvic Lymphadenectomy
Extended pelvic Lymphadenectomy	Experimental		Procedure: Extended pelvic Lymphadenectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Limited pelvic Lymphadenectomy	Procedure	approximately 10-14 lymph nodes are removed	Limited pelvic Lymphadenectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA-progress	3-monthly Follow-up with PSA-measurement in blood	5 years

Secondary Outcomes

Measure	Description	Time Frame
Comparison of overall survival	Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy	5 years
Comparison of morbidity	Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)
locally-operable tumor according to DRU/TRUS
negative bone scan
negative CT abdomen / pelvis
general condition according to Karnofsky >/= 80%
written consent of the patient
adequate hematological, renal and coagulation physiological functions
Patient compliance and geographic proximity to allow adequate follow-up

Exclusion Criteria:

Manifest secondary malignancy
Secured metastasis by histologically or by imaging
Myocardial infarction or stroke within the last 6 months
Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
severe psychiatric disease
prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
previous pelvic radiotherapy
Patients in a closed institution according to an authority or court decision
People who are in a dependent relationship or working relationship with the sponsor or investigator
simultaneous participation in another clinical trial

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heidrun Rexer	Contact			heidrun.rexer@meckevidence.de
Axel Heidenreich, Prof. Dr.	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus Maria Hilf	Recruiting	Krefeld	Dießemer Bruch 80	47805	Germany

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