Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

Study Overview
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Brief Summary
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Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost. It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?

Detailed Description
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50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study. Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy. Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately. Positive LN yield pf ICG guided LND and conventional LND is compared.

Official Title
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Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?

Conditions
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Prostate Cancer, Lymph Node Metastases

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed locally limited prostate cancer; Intermediate or high risk tumor Recommended and planned prostatectomy; Completed and signed written consent; Voluntarily agreement to participate in this study Age of the study participants ≥ 18 years. Exclusion Criteria: Allergic reaction to active ingredient (indocyanine green); Iodine allergy; Hyperthyroidism; High-grade renal impairment; High-grade hepatic insufficiency; Unwillingness to the storage and disclosure of pseudonymous disease and personal data psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG group<br>ICG injection before LRRP via cystoscopy | Drug: Indocyanine green<br>* indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy<br>* Other names: Conventional ELND;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indocyanine green postive lymph node numbers | total number of dissected lymph nodes which are indocyanine green positive | 15 day after surgery | 
| Total lymph node numbers of conventional extended lymph node dissection | total number of dissected lymph nodes during conventional extended lymph node dissection | 15 day after surgery | 
| pathology of indocyanine green positive lymph nodes | İndocyanine green positvie lymph nodes are malign or benign | 15 day after surgery | 
| pathology of lymph nodes | Pathology of material from conventional extended lymph node dissection | 15 day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer