The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients Treated With Radical Prostatectomy and Extended Pelvic Lymph Node Dissection

The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraoperative gamma probe and a radioactive labelled PSMA ligand (99mTc-PSMA-I&S). We hypothesize that 99mTc-PSMA-I&S radio-guided surgery (99mTc-PSMA-RGS) might assist physicians in the identification of patients with LNI candidate for an extended pelvic lymph node dissection (ePLND). Overall, 100 men with a LNI risk >5% according to the Briganti nomogram will be submitted to 68Ga-PSMA PET/MRI followed by 99mTc-PSMA-RGS and ePLND. The aims are 1) to assess the safety and tolerability of 99mTc-PSMA-I&S; 2) to assess the accuracy of 99mTc-PSMA-RGS in the identification of LNI compared to available clinical tools and to molecular imaging (i.e., 68Ga-PSMA PET/MRI); 3) to assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the standard ePLND template.

开始日期2021-05-15

申办/合作机构

Ospedale San Raffaele Srl

NCT04857502 / Recruiting早期临床1期IIT

99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.

开始日期2021-04-27

申办/合作机构

Jonsson Comprehensive Cancer Center

100 项与 99m-TC-PSMA-I&S 相关的临床结果

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100 项与 99m-TC-PSMA-I&S 相关的转化医学

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项与 99m-TC-PSMA-I&S 相关的文献（医药）

2024-01-01·Therapeutic Advances in Medical Oncology

Diagnostic value of [^99mTc]Tc-PSMA-I&S-SPECT/CT for the primary staging and restaging of prostate cancer

Article

作者: Farkas, István ; Pávics, László ; Varga, Linda ; Mikó, Zsófia ; Czékus, Tamás ; Bakos, Annamária ; Besenyi, Zsuzsanna ; Urbán, Szabolcs ; Sipka, Gábor ; Maráz, Anikó ; Bajory, Zoltán

Background: A large number of studies have proved that prostate-specific membrane antigen-positron emission tomography/computer tomography (PSMA-PET/CT) provides excellent accuracy in primary staging and restaging of prostate cancer. Less data exist with PSMA-single photon emission computed tomography (SPECT)/CT investigations. Objective: The aim of this study was to evaluate the performance of [99mTc]Tc-PSMA-I&S (for imaging and surgery) in prostate cancer. Design and methods: We retrospectively analysed PSMA-SPECT/CT scans of 20 healthy volunteers and 100 male patients with prostate cancer. All of them had histologically confirmed prostate cancer. In all, 28 patients were examined for primary staging and 72 for biochemical recurrence or progressive disease. Whole body SPECT/CT imaging was carried out 6 h after the intravenous administration of 666 ± 102 MBq [99mTc]Tc-PSMA-I&S. Images were evaluated visually and semi-quantitatively. Results: Patient-based sensitivity, specificity, positive predictive value, negative predictive value and accuracy for primary prostate cancer were 86%, 100%, 100%, 83% and 92%, respectively. For detecting metastases in primary staging, these values were 88%, 100%, 100%, 85% and 93%, respectively. The radiopharmaceutical uptake of primary prostate cancer was significantly higher than in normal prostate. The patient-based sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the method in the visualization of local recurrence were 67%, 100%, 100%, 86% and 89%, and for detecting metastases in restaging were 91%, 92%, 98%, 75% and 91%, respectively. In restaging, detection rates were 37% under prostate-specific antigen level of 1 ng/mL, 74% between 1 and 5 ng/mL and 80% >5 ng/mL. Conclusion: [99mTc]Tc-PSMA-I&S-SPECT/CT can be easily integrated into the routine diagnostic practice, and it provides usable data in primary staging and restaging of prostate cancer. Quantitative assessment of PSMA-SPECT/CT has the potential to be used to differentiate between physiological and pathological intraprostatic tracer uptake.

2023-08-01·European Urology Open Science

State of the Art in Prostate-specific Membrane Antigen–targeted Surgery—A Systematic Review

Review

作者: Marra, Giancarlo ; Knipper, Sophie ; van der Mierden, Stevie ; van der Poel, Henk G ; Maurer, Tobias ; Berrens, Anne-Claire ; van Leeuwen, Pim J ; Donswijk, Maarten L ; van Leeuwen, Fijs W B

ContextIdentifying malignant tissue and leaving adjacent structures undisturbed constitute an ongoing challenge in prostate cancer (PCa) surgery. Image and radioguided surgical technologies targeting the prostate-specific membrane antigen (PSMA) receptor may facilitate identification and removal of diseased tissue.ObjectiveTo perform a systematic review of the clinical studies on PSMA-targeted surgery.Evidence acquisitionThe MEDLINE (OvidSP), Embase.com, and Cochrane Library databases were searched. Identified reports were critically appraised according to the Idea, Development, Exploration, Assessment, Long-term framework criteria. The risk of bias (RoB) was assessed as per the Risk Of Bias In Non-randomized Studies-of Interventions tool. The strengths and limitations of the techniques and corresponding oncological outcomes were extracted as areas of interest. Data were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.Evidence synthesisIn total, 29 reports were selected, including eight prospective studies, 12 retrospective analyses, and nine case reports, all with a high or an unclear RoB. In 72.4% of studies, PSMA targeting was achieved via radioguided surgery (RGS), predominantly using ^99mTc-PSMA-I&S (66.7%). Hybrid approaches that complement RGS with optical guidance are emerging. The majority of studies retrieved were pilot studies with a short follow-up. In 13 reports, salvage lymph node surgery was discussed (44.8%). In 12 more recent reports (41.4%), PSMA targeting was studied in primary PCa surgery (50.0% lymph nodes and 50.0% surgical margins), and four studied both primary and salvage surgery (13.8%). Overall, specificity was higher than sensitivity (median 98.9% and 84.8%, respectively). Oncological outcomes were discussed only in reports on the use of ^99mTc-PSMA-I&S in salvage surgery (median follow-up of 17.2 mo). A decline in prostate-specific antigen level of >90% ranged from 22.0% to 100.0%, and biochemical recurrence ranged from 50.0% to 61.8% of patients.ConclusionsIn PSMA-targeted surgery, most studies address salvage PSMA-RGS using ^99mTc-PSMA-I&S. Available evidence suggests that the specificity of intraoperative PSMA targeting is higher than the sensitivity. The studies that included follow-up did not yet objectify a clear oncological benefit. Lacking solid outcome data, PSMA-targeted surgery remains investigational.Patient summaryIn this paper, we review recent advances in prostate-specific membrane antigen (PSMA)-targeted surgery, which is used to help identify and remove prostate cancer. We found good evidence to suggest that PSMA targeting helps identify prostate cancer during surgery. The oncological benefits have yet to be investigated further.

2023-07-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Delayed Imaging Improves Lesion Detectability in [^99mTc]Tc-PSMA-I&S SPECT/CT in Recurrent Prostate Cancer.

Article

作者: Knipper, Sophie ; Maurer, Tobias ; Berliner, Christoph ; Pose, Randi ; Koehler, Daniel ; Kroenke, Markus ; Chantadisai, Maythinee ; Bannas, Peter ; Eiber, Matthias ; Steinhelfer, Lisa

Our objective was to compare the ability to detect histopathologically confirmed lymph node metastases by early and delayed [^99mTc]Tc-PSMA-I&S SPECT/CT in early biochemically recurrent prostate cancer. Methods: We retrospectively analyzed 222 patients selected for radioguided surgery using [^99mTc]Tc-PSMA-I&S SPECT/CT at different time points after injection (≤4 h and >15 h). In total, 386 prostate-specific membrane antigen (PSMA) PET predetermined lesions were analyzed on SPECT/CT using a 4-point scale, and the results were compared between early and late imaging groups, with uni- and multivariate analyses performed including prostate-specific antigen, injected [^99mTc]Tc-PSMA-I&S activity, Gleason grade group, initial TNM stage, and, stratified by size, PSMA PET/CT-positive lymph nodes. PSMA PET/CT findings served as the standard of reference. Results: [^99mTc]Tc-PSMA-I&S SPECT/CT had a significantly higher positivity rate for detecting lesions in the late than the early imaging group (79%, n = 140/178, vs. 27%, n = 12/44 [P < 0.05] on a patient basis; 60%, n = 195/324, vs. 21%, n = 13/62 [P < 0.05] on a lesion basis). Similar positivity rates were found when lesions were stratified by size. Multivariate analysis found that SUV_max on PSMA PET/CT and the uptake time of [^99mTc]Tc-PSMA-I&S were independent predictors for lesion detectability on SPECT/CT. Conclusion: Late imaging (>15 h after injection) should be preferred when [^99mTc]Tc-PSMA-I&S SPECT/CT is used for lesion detection in early biochemical recurrence of prostate cancer. However, the performance of PSMA SPECT/CT is clearly inferior to that of PSMA PET/CT.

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适应症	最高研发状态	国家/地区	公司	日期
前列腺癌	药物发现	意大利	San Raffaele SpA	2021-04-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO_GU2017	N/A	复发性前列腺癌	13	Tc-99m-PSMA-guided gamma probe (Tc-99m-PSMA)	(齋廠鬱範齋糧糧獵淵夢) = 鏇蓋製網蓋淵鬱鏇淵範壓糧鏇繭廠範繭齋選襯 (夢壓衊襯製繭鬱壓選築 ) 更多	-	2017-03-29