NCT05109910Recruiting
The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 18 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 17 Nov 2021
- Primary completion date
- Nov 2024
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT05109910
What you commit to
- Study type: Interventional
- Planned participants: 284
- From 17 Nov 2021 to the primary completion date, Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neoadjuvant hormone deprivation therapy
Other
- American Society of Anaesthesiology (ASA) classification \> 3
- Patients with a contradiction for a lymphadenectomy
- Absence or withdrawal of an informed consent
- Evidence of metastases on pre-operative PSMA PET/CT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NKI-AVL Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.