We want to study the relationship between the extent of lymphadenectomy and surgical complications. MedDRA version: 21.1 Level: LLT Classification code 10070467 Term: Pelvic lymphadenectomy System Organ Class: 100000004865 MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - N
Conditions
Interventions
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: INDOCYANINE GREEN
CAS Number: 3599-32-4
Other desc
Sponsors
Grupo de Investigación en Tumores Uro-oncológicos
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men diagnosed with prostate cancer, over 18 years of age, subsidiaries of treatment with PR who wish to participate in the study and are trained to sign informed consent. Intermediate and high clinical risk CP according to the classification of the NCCN guidelines. Score of the Eastern Cooperative Oncology Group ECOG = 0 at the time of diagnosis of prostate cancer. ASA, I, II or III score Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Androgen deprivation therapy prior to surgery. The use of finasteride or Dutasteride is allowed. • Body mass index greater than 40 • Very low, low and very high risk groups. • Another tumor, excluding the basocellular or spinocellular of the dermis. If other tumors are allowed if the patient is> 2 years free of disease. . • History of major surgery of the rectum or sigma. • Active diverticulitis. • Psychological alterations, or family, sociocultural or geographical conditions that - in the opinion of the researcher - prevent the patient from completing the study. • Radiation therapy treatment, previous brachytherapy. If focal treatment is allowed prior to the indication of radical prostatectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that selective lymphadenectomy of the nodes stained with indocyanine green decreases the risk of complications; Secondary Objective: To determine whether lymph node dissection of the ICG-stained nodes has an equivalent capacity to stage patients diagnosed with PC subsidiary of radical prostatectomy and lymph node dissection. To demonstrate that selective lymphadenectomy has an equivalent cytoreductive ability. ;Primary end point(s): Rate of Complications (any); Timepoint(s) of evaluation of this end point: 6 weeks 12 weeks 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): % of grade 3 complications. % of patients staged as pN1. Absolute number of metastatic nodes in each group. Number of ganglia dissected by gripo Ratio no. of metastatic nodes / no. of absolute nodes % of patients with PSA 0.2 in two consecutive measurements separated from each other 2 weeks) % of patients in bichemical recurrence at two years (PSA> 0.2 in two consecutive measurements separated from each other 2 weeks). Grams in the 24 hours pad test at 3, 6 and 12 months % of pad-free patients 3, 6 and 12 months. % of patients who have required anti-incontinence surgery after 24 months of follow-up. IIEF5 Score at 3, 12 and 24 months. ICIQ-SF Score ; Timepoint(s) of evaluation of this end point: 3 weeks 12 weeks 6 months 1 year 2 years 5 years | — |
Countries
Spain
Contacts
Public ContactPresidente
Grupo de Investigación en Tumores Uro-oncológicos
Outcome results
None listed