Evaluating lymph node removal during prostate cancer surgery
Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)
NA · Martini-Klinik am UKE GmbH · NCT04269512
This study tests whether removing lymph nodes during prostate cancer surgery can help men with intermediate risk prostate cancer do better in the long run, despite the risks involved.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3650 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Martini-Klinik am UKE GmbH (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04269512 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of lymph node dissection during radical prostatectomy for men with localized intermediate risk prostate cancer. It aims to determine whether the removal of lymph nodes improves disease outcomes despite the associated risks, such as prolonged surgery and potential complications like lymphoceles. The study will compare different extents of lymph node dissection to assess their impact on patient prognosis and treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with localized intermediate risk prostate cancer who are scheduled for radical prostatectomy.
Not a fit: Patients with severe comorbidities or contraindications for lymph node dissection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help clarify the benefits and risks of lymph node dissection, potentially leading to improved treatment strategies for prostate cancer patients.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of lymph node dissection in prostate cancer, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- Martini-Klinik am UKE GmbH — Hamburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Markus Graefen — Director
- Study coordinator: Markus Graefen, Prof.
- Email: graefen@uke.de
- Phone: +49 (0)40 7410 53115
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.
Conditions: Prostate Cancer, prostatectomy, lymphadenectomy