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

Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: lymph node dissection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Graefen, Prof.; Phone Number: +49 (0)40 7410 53115; Email: graefen@uke.de
• Study Contact Backup: Name: Jonas Ekrutt, Dr.; Phone Number: +49 (0)40 7410 53115; Email: j.ekrutt@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Martini-Klinik am UKE GmbH
    • Contact: Markus Graefen, Professor; Phone Number: +4904741051300; Email: graefen@uke.de
    • Contact: Anke Renter; Phone Number: +49047410533115; Email: renter@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA recurrence rate	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).	36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lymphoceles and complications	(Clavien classification)	6 months after surgery
quality of life including continence and potency	Questionnaire Expanded prostate cancer index composite (EPIC-26)	6, 12, 24, 36 months after surgery
metastasis-free survival	diagnosis of metastasis after prostatectomy by radiological assessment	36 months

Collaborators and Investigators

• Sponsor: Martini-Klinik am UKE GmbH
• Investigators: Principal Investigator: Markus Graefen, Director

Publications and helpful links

Helpful Links

• Homepage

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: prostatectomy; lymphadenectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PREDICT_MK2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No