Evaluating the role of lymph node dissection in prostate cancer treatment
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
This study is testing if a specific surgery to remove lymph nodes can help men with intermediate- and high-risk prostate cancer do better after having their prostate removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05109910 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of extended pelvic lymph node dissection (ePLND) in men with intermediate- and high-risk prostate cancer undergoing radical prostatectomy. It aims to compare oncologic outcomes between patients who receive ePLND and those who do not, particularly focusing on patients with a calculated risk of lymph node invasion between 5-20%. The study addresses the ongoing debate regarding the therapeutic value of ePLND, considering both its diagnostic benefits and potential complications. By conducting this prospective trial, the researchers hope to clarify the role of ePLND in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with prostate cancer and a calculated risk of lymph node metastases between 5-20%, scheduled for radical prostatectomy.
Not a fit: Patients with a higher risk of lymph node metastases or those with evidence of metastases on pre-operative imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine whether ePLND provides significant oncological benefits for certain prostate cancer patients, potentially reducing unnecessary complications.
How similar studies have performed: While the role of ePLND has been debated, this study is among the first prospective trials specifically targeting patients with a low estimated risk of lymph node invasion, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * American Society of Anaesthesiology (ASA) classification \> 3 * Patients with a contradiction for a lymphadenectomy * Neoadjuvant hormone deprivation therapy * Absence or withdrawal of an informed consent * Evidence of metastases on pre-operative PSMA PET/CT
Where this trial is running
Amsterdam
- Nki-Avl — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Henk G van der Poel, Prof — The Netherlands Cancer Institute
- Study coordinator: Henk G van der Poel, Prof
- Email: h.vd.poel@nki.nl
- Phone: 0205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.