Prostate cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male, aged >= 18 years. * WHO performance status 0,1, or 2. * Written informed consent. * Histopathologically confirmed adenocarcinoma of the prostate * Increased risk of nodal metastases according to the MSKCC nomogram (> 7%) * Scheduled for surgical (laparoscopic) prostatectomy including ePLND * Suitable for RP and ePLND, as per institutional guidelines
Exclusion criteria
Exclusion criteria: * Prostate cancer patients with prior abdominal or inguinal surgery * History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or aller-gic rhinitis * Hyperthyroid or thyroidal adenoma * Kidney insufficiency * History of oversensitivity to FLUORESCITE composites * Patients using beta-blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Determine the technical feasibility of using multispectral fluorescence imaging to distinguish between two lymphatic drainage patterns LNLower limb/abdominal wall (fluorescein) and LNprostate (ICG-99mTc- nanocolloid)) in prostate cancer patients scheduled for RALP + ePLND + SN us-ing the Firefly Si laparoscope (da Vinci Si®) and/or Image 1 HUB HD + D-light P (Karl Storz) system. - Determine whether and where the lymphatic drainage profile of the lower limbs/abdominal wall converge with the drainage profile of the primary tumor: are there lymph nodes containing both fluorescein and ICG-99mTc- nanocolloid | — |
Secondary
| Measure | Time frame |
|---|---|
| - Correlate pathological tumour findings in the excised nodal specimens with the presence of ICG-99mTc- nanocolloid or fluorescein (or lack thereof) in order to assess if separation of the lymphatic drainage pathways in fact also means that no metastases are found in LNLower limb/abdominal wall (fluorescein). - Determine whether fluorescein is also found in lymph nodes in ePLND template on contralateral side of injection in lower limb/abdominal wall - Determine the anatomical relationship between the lymphatic drainage profile of the lower limbs/abdominal wall and the sentinel node of the primary tumor - Determine lymph fluid leakage by measuring this during surgery as this can be a predictive factor for complications: o Leakage yes/no? o Yes: 1cm from lymphnode? * | — |
Countries
Netherlands
Outcome results
None listed