Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity. Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male, aged ≥ 18 years

• Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment

• Scheduled for a (robot-assisted) laparoscopic radical prostatectomy

• Written informed consent

Locations
Other Locations
Netherlands
NKI-AVL
RECRUITING
Amsterdam
Contact Information
Primary
Henk G van der Poel, Prof
h.vd.poel@nki.nl
0205129111
Backup
Hilda A de Barros, MD
h.d.barros@nki.nl
0205129111
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2027-11
Participants
Target number of participants: 284
Treatments
Active_comparator: Radical prostatectomy with an extended pelvic lymph node dissection
According to the standard of care, patients in this arm will receive a radical prostatectomy with a standard bilateral ePLND. This includes the removal of lymph nodes within the obturator fossa and bilateral to the external iliac artery, internal iliac artery and common iliac artery up to the ureteral-vessel crossing.
No_intervention: Radical prostatectomy without an extended pelvic lymph node dissection
Patients in this arm will undergo a radical prostatectomy without a bilateral extended pelvic lymph node dissection. In case of intraoperatively found suspicious lymph nodes, a lymphadenectomy is performed. According to the intention to treat principle, patients with intraoperatively removed lymph nodes remain included in the study.
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov

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