Clinical trial NCT04269512: Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy
Official title: Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostatectomy
lymphadenectomy
Lead sponsor: Martini-Klinik am UKE GmbH
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 3650
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: PSA recurrence rate
timeFrame: 36 months after surgery
Secondary outcomes:
measure: Incidence of lymphoceles and complications
timeFrame: 6 months after surgery
measure: quality of life including continence and potency
timeFrame: 6, 12, 24, 36 months after surgery
measure: metastasis-free survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE GmbH
Study officials:
affiliation: Director
name: Markus Graefen
role: PRINCIPAL_INVESTIGATOR
References: