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Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269512
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Martini-Klinik am UKE GmbH

Brief Summary:

Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.

Since the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.

Therefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.

In this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: lymph node dissection Not Applicable

Detailed Description:
The significance of lymph node dissection in radical prostatectomy has not been conclusively clarified. If a radical prostatectomy is planned, the question occurs if the additional pelvic lymph node dissection (LND) is justified and to what extent it should be performed (limited LND, standard LND or extended LND). On the one hand, the detection of lymph node metastases is associated with a significantly worse course of the tumor disease and requires immediate or delayed hormone-ablative therapy. On the other hand, the lymph node dissection is associated with risks (lymphoceles, thromboses, lymphedema), so that the indication in negative lymph node findings appears questionable. It must be weighed between the diagnostic advantage and the possibility of increased morbidity due to the lymphadenectomy. For localized intermediate risk prostate cancer (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b ), there are currently no recommendations for performing a lymph node dissection during prostatectomy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: extended lymph node dissection
Patients randomized to arm A undergo bilateral lymph node dissection in the pelvic area as part of prostatectomy. At least 10 lymph nodes must be removed.
Procedure: lymph node dissection
At least 10 lymph nodes must be removed.

No Intervention: standard without lymph node dissection
Application of standardized surgical technique without extensive lymph node dissection. If, contrary to expectation, intraoperative suspicion of lymphogenic metastasis results, a lymph node dissection is performed and the patient is excluded from the study (freedom of the surgeon).



Primary Outcome Measures :
  1. PSA recurrence rate [ Time Frame: 36 months after surgery ]
    The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value ≥ 0.2 ng / ml).


Secondary Outcome Measures :
  1. Incidence of lymphoceles and complications [ Time Frame: 6 months after surgery ]
    (Clavien classification)

  2. quality of life including continence and potency [ Time Frame: 6, 12, 24, 36 months after surgery ]
    Questionnaire Expanded prostate cancer index composite (EPIC-26)

  3. metastasis-free survival [ Time Frame: 36 months ]
    diagnosis of metastasis after prostatectomy by radiological assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)
  • scheduled for open radical prostatectomie or DaVinci prostatectomie

Exclusion Criteria:

  • American Society of Anesthesiology Classification> 3
  • Existing contraindications for performing a lymph node dissection
  • Neoadjuvant hormone therapy

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): NCT04269512


Contacts
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Contact: Markus Graefen, Prof. +49 (0)40 7410 53115 graefen@uke.de
Contact: Jonas Ekrutt, Dr. +49 (0)40 7410 53115 j.ekrutt@uke.de

Locations
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Germany
Martini-Klinik am UKE GmbH Recruiting
Hamburg, Germany, 20246
Contact: Markus Graefen, Professor    +4904741051300    graefen@uke.de   
Contact: Anke Renter    +49047410533115    renter@uke.de   
Sponsors and Collaborators
Martini-Klinik am UKE GmbH
Investigators
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Principal Investigator: Markus Graefen Director

Additional Information:
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Responsible Party: Martini-Klinik am UKE GmbH
ClinicalTrials.gov Identifier: NCT04269512    
Other Study ID Numbers: PREDICT_MK2019
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Martini-Klinik am UKE GmbH:
prostatectomy
lymphadenectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases