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

Prostate Cancer Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269512
• Other study ID #: PREDICT_MK2019
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: Martini-Klinik am UKE GmbH
• Contact: Markus Graefen, Prof.
• Phone: +49 (0)40 7410 53115
• Email: graefen[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3650
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Martini-Klinik am UKE GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Martini-Klinik am UKE GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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

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