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Personalised indocyanine-guided lymphadenectomy for prostate cancer: a randomised clinical trial.
de Pablos-Rodríguez, Pedro; Claps, Francesco; Rebez, Giacomo; Vidal Crespo, Natalia; Gómez-Ferrer, Álvaro; Mascarós, Juan Manuel; Collado Serra, Argimiro; Caltrava Fons, Ana; Rubio-Briones, José; Casanova Ramon Borja, Juan; Ramírez Backhaus, Miguel.
Afiliação
  • de Pablos-Rodríguez P; Department of Urology, Research Institute of Biomedical and Health Sciences, Doctoral School of University of Las Palmas de Gran Canaria, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Claps F; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Rebez G; Urology Clinic, Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
  • Vidal Crespo N; Urology Clinic, Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
  • Gómez-Ferrer Á; Department of Urology, Hospital General Universitario Santa Lucía, Murcia, Italy.
  • Mascarós JM; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Collado Serra A; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Caltrava Fons A; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Rubio-Briones J; Department of Pathology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Casanova Ramon Borja J; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
  • Ramírez Backhaus M; Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain.
BJU Int ; 132(5): 591-599, 2023 11.
Article em En | MEDLINE | ID: mdl-37410659
OBJECTIVES: To study the safety and efficacy of a personalised indocyanine-guided pelvic lymph node dissection (PLND) against extended PLND (ePLND) during radical prostatectomy (RP). PATIENTS AND METHODS: Patients who were candidates for RP and lymphadenectomy, with intermediate- or high-risk prostate cancer (PCa) according to the National Comprehensive Cancer Network guidelines, were enrolled in this randomised clinical trial. Randomisation was made 1:1 to indocyanine green (ICG)-PLND (only ICG-stained LNs) or ePLND (obturator fossa, external, internal, and common iliac and presacral LNs). The primary endpoint was the complication rate within 3 months after RP. Secondary endpoints included: rate of major complications (Clavien-Dindo Grade III-IV), time to drainage removal, length of stay, percentage of patients classified as pN1, number of LNs removed, number of metastatic LNs, rate of patients with undetectable prostate-specific antigen (PSA), biochemical recurrence (BCR)-free survival, and rate of patients with androgen-deprivation therapy at 24 months. RESULTS: A total of 108 patients were included with a median follow-up of 16 months. In all, 54 were randomised to ICG-PLND and 54 to ePLND. The postoperative complication rate was higher in the ePLND (70%) vs the ICG-PLND group (32%) (P < 0.001). Differences between major complications in both groups were not statically significant (P = 0.7). The pN1 detection rate was higher in the ICG-PLND group (28%) vs the ePLND group (22%); however, this difference was not statistically significant (P = 0.7). The rate of undetectable PSA at 12 months was 83% in the ICG-PLND vs 76% in the ePLND group, which was not statistically significant. Additionally, there were no statistically significant differences in BCR-free survival between groups at the end of the analysis. CONCLUSIONS: Personalised ICG-guided PLND is a promising technique to stage patients with intermediate- and high-risk PCa properly. It has shown a lower complication rate than ePLND with similar oncological outcomes at short-term follow-up.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata Tipo de estudo: Clinical_trials / Guideline Limite: Humans / Male Idioma: En Revista: BJU Int Assunto da revista: UROLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata Tipo de estudo: Clinical_trials / Guideline Limite: Humans / Male Idioma: En Revista: BJU Int Assunto da revista: UROLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Espanha