scholarly journals The Establishment of New Thresholds for PLND-Validated Clinical Nomograms to Predict Non-Regional Lymph Node Metastases: Using 68Ga-PSMA PET/CT as References

2021 ◽  
Vol 11 ◽  
Author(s):  
Jianhua Jiao ◽  
Zhiyong Quan ◽  
Jingliang Zhang ◽  
Weihong Wen ◽  
Jun Qin ◽  
...  

PurposePLND (pelvic lymph node dissection)-validated nomograms are widely accepted clinical tools to determine the necessity of PLND by predicting the metastasis of lymph nodes (LNMs) in pelvic region. However, these nomograms are in lacking of a threshold to predict the metastasis of extrareolar lymph nodes beyond pelvic region, which is not suitable for PLND. The aim of this study is to evaluate a threshold can be set for current clinical PLND-validated nomograms to predict extrareolar LN metastases beyond pelvic region in high-risk prostate cancer patients, by using 68Ga-PSMA PET/CT as a reference to determine LN metastases (LNMs).Experimental DesignWe performed a retrospective analysis of 57 high-risk treatment-naïve PC patients in a large tertiary care hospital in China who underwent 68Ga-PSMA-617 PET/CT imaging. LNMs was detected by 68Ga-PSMA-617 PET/CT and further determined by imaging follow-up after anti-androgen therapy. The pattern of LN metastatic spread of PC patients were evaluated and analyzed. The impact of 68Ga-PSMA PET/CT on clinical decisions based on three clinical PLND-validated nomograms (Briganti, Memorial Sloan Kettering Cancer Center, Winter) were evaluated by a multidisciplinary prostate cancer therapy team. The diagnostic performance and the threshold of these nomograms in predicting extrareolar LNMs metastasis were evaluated via receiver operating characteristic (ROC) curve analysis.ResultsLNMs were observed in 49.1% of the patients by 68Ga-PSMA PET/CT, among which 65.5% of LNMs were pelvic-regional and 34.5% of LNMs were observed in extrareolar sites (52.1% of these were located above the diaphragm). The Briganti, MSKCC and Winter nomograms showed that 70.2%-71.9% of the patients in this study need to receive ePLND according to the EAU and NCCN guidelines. The LN staging information obtained from 68Ga-PSMA PET/CT would have led to changes of planned management in 70.2% of these patients, including therapy modality changes in 21.1% of the patients, which were mainly due to newly detected non-regional LNMs. The thresholds of nomograms to predict non-regional LNMs were between 64% and 75%. The PC patients with a score >64% in Briganti nomogram, a score >75% in MSKCC nomogram and a score >67% in Winter nomogram were more likely to have non-regional LNMs. The AUCs (Area under curves) of the clinical nomograms (Briganti, MSKCC and Winter) in predicting non-regional LNMs were 0.816, 0.830 and 0.793, respectively.ConclusionsBy using 68Ga-PSMA PET/CT as reference of LNM, the PLND-validated clinical nomograms can not only predict regional LNMs, but also predict non-regional LNMs. The additional information from 68Ga-PSMA PET/CT may provide added benefit to nomograms-based clinical decision-making in more than two-thirds of patients for reducing unnecessary PLND. We focused on that a threshold can be set for current clinical PLND-validated nomograms to predict extrareolar LN metastases with an AUC accuracy of about 80% after optimizing the simple nomograms which may help to improve the efficiency for PC therapy significantly in clinical practice.

2021 ◽  
Author(s):  
Mimmi Bjöersdorff ◽  
Christopher Puterman ◽  
Jenny Oddstig ◽  
Jennifer Amidi ◽  
Sophia Zackrisson ◽  
...  

Abstract Background: Positron emission tomography-computed tomography (PET-CT) can be used to detect and stage metastatic lymph nodes in intermediate to high-risk prostate cancer. Improvements to hardware, such as digital technology, and to software, such as reconstruction algorithms, have recently been made. We compared the capability of detecting regional lymph node metastases using conventional and digital silicon photomultiplier (SiPM)-based PET-CT technology for [18F]-fluorocholine (FCH). Extended pelvic lymph node dissection (ePLND) histopathology was used as the reference method.Methods: Retrospectively, a consecutive series of patients with prostate cancer who had undergone staging with FCH PET-CT before ePLND were included. Images were obtained with either a conventional or a SiPM-based PET-CT and compared. FCH uptake in pelvic lymph nodes beyond the uptake in the mediastinal blood pool was considered to be abnormal.Results: One hundred eighty patients with intermediate or high-risk prostate cancer were examined using a conventional Philips Gemini PET-CT (n = 93) between 2015 and 2017 or a digital GE Discovery MI PET-CT (n = 87) from 2017 to 2018. Images that were obtained using the Philips Gemini PET-CT system showed 19 patients (20%) with suspected lymph node metastases compared with 40 patients (46%) using the GE Discovery MI PET-CT. Sensitivity, specificity, and positive and negative predictive value (PPV and NPV) were 0.30, 0.84, 0.47, and 0.72, respectively, for the Philips Gemini and 0.60, 0.58, 0.30, and 0.83, respectively for GE Discovery MI. Area under the curve (AUC) in a receiver operating characteristics (ROC) analysis was similar between the two PET-CT systems (0.58 and 0.58, P = 0.8).Conclusions: A marked difference in sensitivity and specificity was found for the different PET-CT systems, although similar overall diagnostic performance. This is probably due to differences in both hard- and software, including reconstruction algorithms, and should be considered when new technology is introduced.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Lei Peng ◽  
Jinze Li ◽  
Chunyang Meng ◽  
Jinming Li ◽  
Chengyu You ◽  
...  

Abstract Objective This article aims to evaluate the diagnostic value of 68Gallium-PSMA positron emission tomography/computerized tomography (68Ga-PSMA PET/CT) for lymph node (LN) staging in patients with prostate cancer (PCa) by a meta-analysis of diagnostic tests. Methods We systematically retrieved articles from Web of Science, EMBASE, Cochrane Database, PubMed. The time limit is from the creation of the database until June 2019, and Stata 15 was used for calculation and statistical analyses. Results Sensitivity, specificity, positive and negative likelihood ratio (PLR, NLR), diagnostic odds ratio (DOR) and 95% confidence intervals (CI) be used to evaluate the diagnostic value. A total of 10 studies were included in our meta-analysis, which included 701 individuals. The results of each consolidated summary are as follows: sensitivity of 0.84 (95% CI 0.55–0.95), specificity of 0.95 (95% CI 0.87–0.98), PLR and NLR was 17.19 (95% CI 6.27, 47.17) and 0.17 (95% CI 0.05–0.56), respectively. DOR of 100 (95% CI 18–545), AUC of 0.97 (95% CI 0.95–0.98). Conclusion Our study demonstrates that 68Ga-PSMA PET/CT has a high overall diagnostic value for LN staging in patients with moderate and high-risk PCa. But our conclusions still require a larger sample size, multi-center prospective randomized controlled trial to verify.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e591-e591 ◽  
Author(s):  
David Pfister ◽  
Matthias Schmidt ◽  
Friederike Haidl ◽  
Daniel Porres-Knoblauch ◽  
Alexander Drzezga ◽  
...  

e591 Background: PSMA-PET/CT is the most sensitive diagnostic tool in biochemical recurrent prostate cancer to detect minimal metastatic disease. However, it may be difficult to localize small PSMA-positive lymph nodes intraoperatively. Therefore, it was the aim to investigate whether preoperative Tc-99m-PSMA targeting may improve intraoperative tumor localization by use of a gamma probe. Methods: In 13 Patients Ga-68-PSMA-PET/CT identified iliac lymph nodes in patients suitable for salvage lymph node dissection. On the day before operation a mean activity of 480 MBq Tc-99m-PSMA was injected and gamma camera scintigraphy + SPECT was performed 4-5 hours after tracer application. About 24 hours after tracer application a salvage lymph node dissection was performed on the side of initial suspicious lymph node metastases. Sensitivity, specifity, pos and neg. predictive values were calulated for PSMA-PET/CT and gamma probe use to analyse the additional use. Results: In 9 / 13 patients PSMA-positive metastatic lymph nodes were identified in Ga-68 PSMA-PET/CT. A total of 156 lymph nodes were removed with 14 lymph nodes in 9 patients being positive in histopathologic examination. Sensitivity, specifity, pos and neg. predictive values for PSMA PET/CT and gamma probe were 85% and 79%, 99% and 100%, 85% and 100% and 99% and 98% respectively. In one patient only gamma probe use identified a pathologic lymph node. Conclusions: Gamma probe guided salvage lymph node dissection in PSA recurrent prostate cancer is feasible and had a high concordance with PSMA-PET/CT. However, the additional diagnostic benefit is limited compared to PSMA-PET/CT because in only one patient (7%) a positive lymph node could be identified with the use of the gamma probe outside the standard operative area in salvage lymph node dissection.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. TPS264-TPS264
Author(s):  
Omar Alghazo ◽  
Renu Eapen ◽  
Nattakorn Dhiantravan ◽  
John A. Violet ◽  
Price Jackson ◽  
...  

TPS264 Background: High-risk localised prostate cancer (HRCaP) is treated by radical prostatectomy (RP) or radiotherapy. Despite curative intent, a significant number of men will progress with metastatic disease or local recurrence. Lutetium-177 radiolabelled to the small molecule PSMA-617 targeting prostate-specific membrane antigen (Lu-PSMA) has proven efficacious in men with metastatic castration-resistant prostate cancer who have progressed after standard-of-care. The LuTectomy trial evaluates whether administration of Lu-PSMA before radical prostatectomy in men with HRCaP will deliver high doses of radiation to the prostate and involved lymph nodes. It also aims to assess the feasibility, safety profile and oncological efficacy of Lu-PSMA. Methods: Lutectomy is an open-label, phase I/II non-randomised clinical trial. 20 men with HRCaP defined by European Association of Urology who are scheduled for RP and pelvic lymph node dissection (PLND) will be recruited. All men will have high PSMA-avidity with a standardised uptake value (SUVmax) of ≥ 20 on 68Ga-PSMA PET/CT. The initial 10 participants will receive one cycle of 5GBq Lu-PSMA intravenously and the latter 10 men will receive two cycles of 5GBq Lu-PSMA per cycle six weeks apart. RP with PLND will be performed six weeks later. Participants will be followed up for three years. The primary outcome is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Three-time point quantitative single-photon emission computed tomography (SPECT/CT) will be used to estimate radiation dosimetry using a voxelated technique incorporating partial volume correction. Marrow absorbed dose will also be evaluated using serial blood measures to model pharmacokinetic clearance with a multi-phase exponential model. Translational research samples will include the original biopsy, prostatectomy specimen and plasma/whole blood samples. Secondary objectives include evaluation of the PSMA PET/CT imaging response (defined by SUVmax decline >30%), PSA response, pathological response following Lu-PSMA, adverse effects of Lu-PSMA, surgical safety, and health-related quality of life. Post estimates for time-to-event endpoints will be estimated using the Kaplan-Meier method. The first patient was recruited in July 2020 and recruitment is expected to take up to two years. ClinicalTrials.gov Identifier: NCT04430192. Funding: Movember and Medical Research Future Fund (MRFF), Endocyte Inc., a Novartis Company, E.J. Whitten Foundation. Clinical trial information: NCT04430192.


2017 ◽  
Vol 197 (4S) ◽  
Author(s):  
Can Obek ◽  
Tunkut Doganca ◽  
Emre Demirci ◽  
Meltem Ocak ◽  
Ali Riza Kural ◽  
...  

2019 ◽  
Vol 47 (3) ◽  
pp. 674-686 ◽  
Author(s):  
Meghana Kulkarni ◽  
Simon Hughes ◽  
Andrew Mallia ◽  
Victoria Gibson ◽  
Jennifer Young ◽  
...  

Abstract Purpose To determine the impact on clinical management of patients with high-risk (HR) prostate cancer at diagnosis and patients with biochemical recurrence (BCR) using a new kit form of 68Ga-prostate-specific membrane antigen (PSMA), namely tris(hydroxypyridinone) (THP)-PSMA, with positron emission tomography-computed tomography (PET-CT). Methods One hundred eighteen consecutive patients (50 HR, 68 BCR) had management plans documented at a multidisciplinary meeting before 68Ga-THP-PSMA PET-CT. Patients underwent PET-CT scans 60-min post-injection of 68Ga-THP-PSMA (mean 159 ± 21.2 MBq). Post-scan management plans, Gleason score, prostate-specific antigen (PSA) and PSA doubling time (PSAdt) were recorded. Results HR group: 12/50 (24%) patients had management changed (9 inter-modality, 3 intra-modality). Patients with PSA < 20 μg/L had more frequent management changes (9/26, 34.6%) compared with PSA > 20 μg/L (3/24, 12.5%). Gleason scores > 8 were associated with detection of more nodal (4/16, 25% vs 5/31, 16.1%) and bone (2/16, 12.5% vs 2/31, 6.5%) metastases. BCR group: Clinical management changed in 23/68 (34%) patients (17 inter-modality, 6 intra-modality). Forty out of 68 (59%) scans were positive. Positivity rate increased with PSA level (PSA < 0.5 μg/L, 0%; PSA 0.5–1.0 μg/L, 35%; PSA 1.0–5.0 μg/L, 69%; PSA 5.0–10.0 μg/L, 91%), PSAdt of < 6 months (56% vs 45.7%) and Gleason score > 8 (78.9% vs 51.2%). Conclusions 68Ga-THP-PSMA PET-CT influences clinical management in significant numbers of patient with HR prostate cancer pre-radical treatment and is associated with PSA. Management change also occurs in patients with BCR and is associated with PSA and Gleason score, despite lower scan positivity rates at low PSA levels < 0.5 μg/L.


2020 ◽  
Author(s):  
Lei Peng ◽  
Jinze Li ◽  
Chuanyang Meng ◽  
Jinming Li ◽  
Chengyu You ◽  
...  

Abstract Objective: This article aims to evaluate the diagnostic value of 68Gallium-PSMA positron emission tomography/computerized tomography (68Ga-PSMA PET/CT) for lymph node (LN) staging in patients with prostate cancer (PCa) by a meta-analysis of diagnostic tests.Methods: We systematically retrieved articles from Web of Science, EMBASE, Cochrane Database, PubMed. The time limit is from the creation of the database until June 2019, and Stata 15 was used for calculation and statistical analyses.Results: Sensitivity, specificity, positive and negative likelihood ratio (PLR, NLR), diagnostic odds ratio (DOR) and 95% confidence intervals (CI) be used to evaluate the diagnostic value. A total of 10 studies were included in our meta-analysis, which included 701 individuals. The results of each consolidated summary are as follows: sensitivity of 0.84 (95% CI: 0.55-0.95), specificity of 0.95 (95% CI: 0.87-0.98), PLR and NLR was 17.19 (95% CI: 6.27, 47.17) and 0.17 (95% CI: 0.05-0.56), respectively. DOR of 100 (95% CI: 18-545), AUC of 0.97 (95% CI: 0.95-0.98). Conclusion: Our study demonstrates that 68Ga-PSMA PET/CT has a high overall diagnostic value for LN staging in patients with moderate and high-risk PCa. But our conclusions still require a larger sample size, multi-center prospective randomized controlled trial to verify.


2020 ◽  
Author(s):  
Lei Peng ◽  
Jinze Li ◽  
Chuanyang Meng ◽  
Jinming Li ◽  
Chengyu You ◽  
...  

Abstract Objective: This article aims to evaluate the diagnostic value of68Gallium-PSMA positron emission tomography/computerized tomography (68Ga-PSMA PET/CT) for lymph node (LN) staging in patients with prostate cancer (PCa) by a meta-analysis of diagnostic tests.Methods: We systematically retrieved articles from PubMed, Embase, Web of Science with a limited period from January 1, 2016, to December 1, 2019, and Stata 15 was used for calculation and statistical analyses.Results: Sensitivity, specificity, positive and negative likelihood ratio (PLR, NLR), diagnostic odds ratio (DOR) and 95% confidence intervals (CI) be used to evaluate the diagnostic value. A total of 10 studies were included in our meta-analysis, which included 701 individuals. The results of each consolidated summary are as follows: sensitivity of 0.84 (95% CI: 0.55-0.95), specificity of 0.95 (95% CI: 0.87-0.98), PLR and NLR was 17.19 (95% CI: 6.27, 47.17) and 0.17 (95% CI: 0.05-0.56), respectively. DOR of 4.6 (95% CI: 2.91-6.30), AUC of 0.97 (95% CI: 0.95-0.98).Conclusion: Our study demonstrates that 68Ga-PSMA PET/CT has a high overall diagnostic value for LN staging in patients with moderate and high-risk PCa. But our conclusions still require a larger sample size, multi-center prospective randomized controlled trial to verify.


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