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JOURNAL ONKOLOGIE – STUDIE
PREDICT

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

Rekrutierend

NCT-Nummer:
NCT04269512

Studienbeginn:
Oktober 2019

Letztes Update:
12.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Martini-Klinik am UKE GmbH

Collaborator:
-

Studienleiter

Markus Graefen
Principal Investigator
Director

Kontakt

Studienlocations
(1 von 1)

Martini-Klinik am UKE GmbH
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Markus Graefen, Professor
Phone: +4904741051300
E-Mail: graefen@uke.de

Anke Renter
Phone: +49047410533115
E-Mail: renter@uke.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

  • 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.
  • 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).

Geprüfte Regime

  • lymph node dissection:
    At least 10 lymph nodes must be removed.

Quelle: ClinicalTrials.gov


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