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

NCT04269512 | Active Not Recruiting

• 1 other identifier: PREDICT_MK2019
• Study Type: interventional
• Target: 3,650
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostatectomy; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of lymphoceles and complications

  6 months after surgery

• quality of life including continence and potency

  6, 12, 24, 36 months after surgery

• metastasis-free survival

  36 months

Study Arms (2)

extended lymph node dissection

ACTIVE COMPARATOR

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

standard without lymph node dissection

NO INTERVENTION

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).

Interventions

lymph node dissection PROCEDURE

At least 10 lymph nodes must be removed.

extended lymph node dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Martini-Klinik am UKE GmbH: lead

Study Sites (1)

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

Related Links

• Homepage

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Markus Graefen

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: October 15, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)