scholarly journals Prospective comparison of 18F-PSMA-1007 PET/CT, whole-body MRI and CT in primary nodal staging of unfavourable intermediate- and high-risk prostate cancer

2021 ◽  
Author(s):  
Simona Malaspina ◽  
Mikael Anttinen ◽  
Pekka Taimen ◽  
Ivan Jambor ◽  
Minna Sandell ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Lymph Nodes ◽  
The Other ◽  
Imaging Modalities ◽  
Whole Body ◽  
Nodal Staging ◽  
Prospective Comparison ◽  
Contrast Enhanced Ct ◽  
Pet Ct

Abstract Purpose To prospectively compare 18F-prostate-specific membrane antigen (PSMA)-1007 positron emission tomography (PET)/CT, whole-body magnetic resonance imaging (WBMRI) including diffusion-weighted imaging (DWI) and standard computed tomography (CT), in primary nodal staging of prostate cancer (PCa). Methods Men with newly diagnosed unfavourable intermediate- or high-risk PCa prospectively underwent 18F-PSMA-1007 PET/CT, WBMRI with DWI and contrast-enhanced CT within a median of 8 days. Six readers (two for each modality) independently reported pelvic lymph nodes as malignant, equivocal or benign while blinded to the other imaging modalities. Sensitivity, specificity and accuracy were reported according to optimistic (equivocal lesions interpreted as benign) and pessimistic (equivocal lesions interpreted as malignant) analyses. The reference standard diagnosis was based on multidisciplinary consensus meetings where available histopathology, clinical and follow-up data were used. Results Seventy-nine patients completed all the imaging modalities, except for one case of interrupted WBMRI. Thirty-one (39%) patients had pelvic lymph node metastases, which were detected in 27/31 (87%), 14/31 (45%) and 8/31 (26%) patients by 18F-PSMA-1007 PET/CT, WBMRI with DWI and CT, respectively (optimistic analysis). In 8/31 (26%) patients, only 18F-PSMA-1007 PET/CT detected malignant lymph nodes, while the other two imaging modalities were reported as negative. At the patient level, sensitivity and specificity values for 18F-PSMA-1007 PET/CT, WBMRI with DWI and CT in optimistic analysis were 0.87 (95%CI 0.71–0.95) and 0.98 (95%CI 0.89–1.00), 0.37 (95%CI 0.22–0.55) and 0.98 (95%CI 0.89–1.00) and 0.26 (95%CI 0.14–0.43) and 1.00 (95%CI 0.93–1.00), respectively. Conclusion 18F-PSMA-1007 PET/CT showed significantly greater sensitivity in nodal staging of primary PCa than did WBMRI with DWI or CT, while maintaining high specificity. Clinical trial registration Clinicaltrials.gov ID: NCT03537391

Detection of Lymph Node Metastases in Patients With Prostate Cancer: Comparing Conventional and Digital [18F]-fluorocholine PET-CT Using Histopathology as Reference

2021 ◽  
Author(s):  
Mimmi Bjöersdorff ◽  
Christopher Puterman ◽  
Jenny Oddstig ◽  
Jennifer Amidi ◽  
Sophia Zackrisson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Lymph Nodes ◽  
Lymph Node Metastases ◽  
Reconstruction Algorithms ◽  
High Risk Prostate Cancer ◽  
Pet Ct ◽  
Risk Prostate Cancer ◽  
Node Metastases

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.

A phase II study of 99mTc-trofolastat (MIP-1404) SPECT/CT to identify and localize prostate cancer in high-risk patients undergoing radical prostatectomy (RP) and extended pelvic lymph node dissection (EPLND) compared to histopathology: An interim analysis.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 94-94 ◽  
Author(s):  
Kevin Mark Slawin ◽  
William J. Ellis ◽  
Peter Tenke ◽  
Steven Joniau ◽  
Boris Y. Alekseev ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Lymph Nodes ◽  
Sensitivity And Specificity ◽  
Interim Analysis ◽  
Whole Body ◽  
Comparative Performance ◽  
Pelvic Mri ◽  
Pelvic Lymph Nodes ◽  
Secondary Endpoints

94 Background: Technetium (Tc99m) trofolastat (USANC) is a novel urea-based small molecule SPECT radiotracer with utility in imaging overexpression of PSMA in prostate cancer (PCa). Unlike earlier agents targeting PSMA, this ligand is rapidly internalized and retained in tumors. We conducted an open-label, multicenter phase 2 study in the US and Europe (NCT01667536). An interim analysis was performed at approximately 50% accrual. Methods: Patients (pts) with confirmed adenocarcinoma of the prostate scheduled for RP with EPLND at high risk for disease outside of the prostate gland were eligible. High risk pts were ≥cT3 or Kattan nomogram score ≥130. Within 30 days of screening, pts required a bone scan and pelvic MRI. After enrollment, pts received trofolastat followed by whole-body planar and SPECT/CT imaging 3 to 6 hrs later. Pts then underwent RP with EPLND within 21 days. SPECT/CT images were evaluated centrally by 3 readers blinded to clinical information and compared to on-site pathology assessments using a common scoring template. The primary endpoint was the ability of trofolastat to detect PCa within the gland. Secondary endpoints included detection of extent and location within the gland, pelvic lymph nodes and comparative performance against MRI. Results: 84 pts were enrolled to date from 16 centers. Interim data is available for 54 pts. A majority (≥2/3) of SPECT/CT readers correctly identified the presence or absence of primary PCa in 51/54 (94%, 85-98 95% CI) patients including 2 true-negative cases treated with neoadjuvant enzalutamide. Sensitivity and specificity were 94% (84-98 95% CI) and 100% (34-100 95% CI) respectively. Conclusions: Based on the interim data available, trofolastat has accurately detected primary prostate carcinoma within the gland with high sensitivity and specificity in high-risk pts prior to surgery. Updated results, analyses of secondary endpoints, pelvic lymph nodes, and comparative performance vs. MRI from this ongoing study will be presented. Clinical trial information: NCT01667536. [Table: see text]

Study of the dosimetry, safety, and potential benefit of 177Lu-PSMA-617 radionuclide therapy prior to radical prostatectomy in men with high-risk localized prostate cancer (LuTectomy study).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. TPS264-TPS264
Author(s):  
Omar Alghazo ◽  
Renu Eapen ◽  
Nattakorn Dhiantravan ◽  
John A. Violet ◽  
Price Jackson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Lymph Nodes ◽  
Photon Emission ◽  
Absorbed Dose ◽  
Emission Computed Tomography ◽  
Psma Pet ◽  
Pet Ct

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.

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 ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Lymph Nodes ◽  
Clinical Decision Making ◽  
Care Hospital ◽  
Pelvic Region ◽  
Psma Pet ◽  
Pet Ct ◽  
The Impact

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.

Experience of 1,000 patients.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 294-294
Author(s):  
Julieta Iorio ◽  
Martin Eleta ◽  
Florencia Bambacci ◽  
Lucrecia Cuneo ◽  
David Polillo
Keyword(s):  
Prostate Cancer ◽  
Local Recurrence ◽  
The Other ◽  
Emission Tomography ◽  
Whole Body ◽  
Dual Phase ◽  
Positron Emission ◽  
Pet Ct ◽  
Frequent Site ◽  
Biochemical Progression

294 Background: The aim of this study is to present our experience between the correlation of 18 fluorocholine (FCH) positron emission tomography (PET)/computed tomography (CT) findings and PSA levels in detecting local recurrence, lymphatic/haematogenous involvement in patients with prostate carcinoma. Methods: 1075 patients with prostate cancer were enrolled between July 2012 and August 2017. Patients were separated in two main groups: biochemical progression 913 (85%) and 162 (15%) staging. Each group was divided in three subgroups according to PSA levels: ≤1 ng/ml; ≥ 1-5ng/ml and > 5 ng/ml. All of them underwent “Dual phase” PET-CT consisting of intial pelvis starting 20 minutes after the injection of 18 F-Choline followed by 1 hour delayed PET-CT of the whole body. Results: 1641 lesions showed increased uptake on FCH-PET and were interpretated as local recurrence or metastases .According to biochemical progression we identified for each subgroup: 118 patients (13%) (≤1 ng/ml); 265 patients (29%) (≥ 1-5ng/ml); 530 patients (58%) ( > 5 ng/ml) and for staging we identified for each subgroup: 81 patients (50%) (≤1 ng/ml); 47 patients (29%) (≥ 1-5ng/ml); 20 patients (34%) ( > 5 ng/ml). The results are shown on table 1: Patients presenting biochemical progression the majority of them have PSA levels of 5 ng/ml or more and the most frequent site of metastases were pelvic lymph nodes, on the other hand, for staging patients we have found that most of them have PSA levels of ≤1 ng/ml and we detected that they most commonly have local compromise. Conclusions: In our experience 18 FCH PET/CT is a useful tool to detect lesions in patients with biochemical progression but it seems to have limited value for staging. [Table: see text]

PD-0117 CHOLINE PET-CT AND DIFFUSION-WEIGHTED MRI FOR NODAL STAGING IN PROSTATE CANCER AT HIGH RISK FOR NODAL METASTASES

2012 ◽  
Vol 103 ◽  
pp. S45-S46
Author(s):  
L. Van den Bergh ◽  
S. Joniau ◽  
E. Lerut ◽  
R. Oyen ◽  
C.M. Deroose ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Nodal Metastases ◽  
Diffusion Weighted Mri ◽  
Nodal Staging ◽  
Choline Pet ◽  
Diffusion Weighted ◽  
Pet Ct ◽  
And Diffusion
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