Radioisotope-guided Lymphadenectomy for Pelvic Lymph Node Staging in Patients With Intermediate- and High-risk Prostate Cancer (The Prospective SENTINELLE Study)

Abstract

Purpose: Our aim was to prospectively evaluate the diagnostic accuracy of sentinel lymph node biopsy-guided lymph node dissection compared to extended pelvic lymph node dissection in patients with intermediate-or high-risk prostate cancer. Materials and Methods: We conducted a prospective, single-arm, multicenter study at 3 tertiary centers in France between February 2012 and May 2019. Eligible patients had clinically localized intermediate-or high-risk prostate cancer. After intraprostatic injection of (99m)Tc-nanocolloid, the locations of the sentinel lymph nodes were defined by preoperative lymphoscintigraphy. Surgical excision of the sentinel lymph nodes was performed using intraoperative gamma probe guidance. After resection of the sentinel lymph nodes, extended pelvic lymph node dissection was performed in all patients. We assessed the diagnostic accuracy of the sentinel lymph node biopsy method using extended pelvic lymph node dissection as the reference standard. This trial was registered in ClinicalTrials.gov (NCT02732392). Results: A total of 162 men cN0M0 (CT scan and bone scan) were enrolled: 106 (65.4%) and 56 (34.6%) patients had intermediate-and high-risk prostate cancer, respectively. The median number of nodes retrieved was 14 (mean 16, IQR 10-21) per patient. At final pathological analysis, 22 patients (13.6%) were pND. Sensitivity, specificity, negative predictive value, and positive predictive value of sentinel lymph node biopsy method in detecting patients with at least 1 lymph node metastasis were 95.4% (95% CI, 75.1-99.7), 100% (95% CI, 96.6-100), 99.2% (95% CI, 95.5-99.9), and 100% (95% CI, 80.7-100), respectively. Conclusions: Our multicenter prospective study supports that sentinel lymph node biopsy is a very effective and sensitive method for pelvic lymph node staging in patients with intermediate-or high-risk localized prostate cancer.

Development and validation of novel nomogram to identify the candidates for extended pelvic lymph node dissection for prostate cancer patients in the robotic era

“…Meanwhile, intraoperative guidance for sentinel node detection in PCa has been developed. PLND following transperitoneal indocyanine green injection showed a negative predictive value of 97.4% 24 while intraprostatic injection of (99 m) Tc‐nanocolloid and intraoperative gamma probe guidance showed a sensitivity of 95.4% and 100% specificity 25 . In the future, the combination of precise preoperative imaging modalities, clinical factors, pathological results from biopsy, and intraoperative imaging may accurately predict possibility of LNI or area of LNI, consequently avoid unnecessary ePLND.…”

“…PLND following transperitoneal indocyanine green injection showed a negative predictive value of 97.4% 24 while intraprostatic injection of (99 m) Tc-nanocolloid and intraoperative gamma probe guidance showed a sensitivity of 95.4% and 100% specificity. 25 In the future, the combination of precise preoperative imaging modalities, clinical factors, pathological results from biopsy, and intraoperative imaging may accurately predict possibility of LNI or area of LNI, consequently avoid unnecessary ePLND. We need to consider that ePLND is recommended not for the therapeutic effect of ePLND, but for the accurate diagnosis of LNI to provide further consecutive treatment options.…”

Sentinel Lymph Node Techniques in Urologic Oncology: Current Knowledge and Application

“…Moreover, only 10 of 18 patients (55.6%) had metastasis to SLNs only [80]. Some studies showed similar results, indicating high accuracy rates, but many of them also revealed low detection rates of all metastatic LNs, preventing the application of SLND only [102][103][104][105][106][107]. Another study evaluating the efficacy of intratumoral (IT) radiotracer injections was conducted by Wit et al In the IT group, metastatic SLNs were 73.7% of all positive LNs compared to 37.3% in the group receiving intraprostatic (IP) injections (p = 0.015).…”

The role of nuclear medicine tracers for prostate cancer surgery: from preoperative to intraoperative setting

“…In multivariable analyses, only SNB with hybrid tracer [odds ratio (OR): 1.61; P = 0.002] achieved independent predictor status for pN1 detection at final pathology. Lannes et al [28 ▪ ], tested the diagnostic accuracy of SNB in a prospective, single-arm, multicenter study. A total of 162 individuals cN0M0 at conventional imaging were enrolled.…”