It is unclear whether the imaging modality used to guide metastasis-directed therapy (MDT) influences outcomes in oligometastatic castration-resistant prostate cancer (omCRPC). Methods: We performed an updated analysis of the PRECISE-MDT cohort, adding 27 patients to the original cohort. MDT guided by prostate-specific membrane antigen (PSMA) PET/CT, choline PET/CT, and conventional imaging was compared in 102 patients with omCRPC. The primary outcomes were biochemical recurrence-free survival and overall survival after adjustment for inverse probability of treatment weighting. Results: MDT was guided by conventional imaging in 20 (19.6%) patients, choline PET/CT in 56 (54.9%) patients, and PSMA PET/CT in 26 (25.5%) patients. PSMA PET/CT guidance yielded longer biochemical recurrence-free survival than did choline PET/CT (median not reached [NR] vs. 11.7 mo, P = 0.031) and conventional imaging (NR vs. 7.1 mo, P = 0.002). Overall survival favored PSMA PET/CT versus conventional imaging (NR vs. 46.0 mo, P = 0.036). Conclusion: PSMA PET/CT guidance was associated with improved clinical outcome, supporting its therapeutic relevance for MDT planning in omCRPC.

Background and Objective: Conventional imaging with pelvic magnetic resonance imaging (MRI) and abdominopelvic computed tomography (CT) is still used for staging of prostate cancer (PCa), particularly when molecular imaging is unavailable. mpMRI is currently recommended before prostate biopsy. We evaluated the agreement between MRI and CT for nodal and distant staging, their diagnostic accuracy against surgical nodal staging, and the real-world clinical utility of CT when pelvic MRI is already available. Methods: Among consecutive prostate biopsies, we retrieved patients with unfavorable intermediate- or high-risk PCa who underwent both pelvic MRI and abdominopelvic CT (and bone scan). Agreement for nodal staging was assessed using Cohen’s κ. Diagnostic performance was evaluated in patients undergoing radical prostatectomy with pelvic lymph node dissection, using final pathology as the reference standard. The clinical yield of CT was assessed post hoc, considering nodal or metastatic reclassification or urgent non-PCa-related findings. Key Findings and Limitations: We included 323 consecutive patients. MRI and CT identified cN1 disease in 6.8% and 8.1% of cases, respectively, and showed moderate agreement for pelvic nodal staging (κ = 0.51), with higher agreement in non-surgical patients. Both modalities demonstrated very low sensitivity for nodal metastases (≤ 20%) compared with pathology, with area under the curve (AUC) < 0.60. In the subgroup of patients with also molecular imaging available (n = 82) PSMA PET/CT showed superior performance (AUC = 0.86). MRI and CT (plus bone scan) showed moderate agreement for distant metastasis (κ = 0.56). CT provided clinically relevant information not detectable in mpMRI in 14.1% of patients (number needed to scan = 7). Limitations include the retrospective design and lack of centralized imaging review. Intervention: Imaging strategies were evaluated observationally. Conclusions and Clinical Implications: Pelvic MRI and CT show moderate agreement for nodal staging but poor diagnostic accuracy. Although the incremental value of CT beyond pelvic MRI is limited, it may still contribute to change management when PSMA PET/CT is unavailable.

Introduction:The advent of prostate-specific membrane antigen - positron emission tomography (PSMA-PET) imaging influences prostate cancer (PCa) salvage radiotherapy (SRT) decision-making, especially in biochemical recurrence (BCR) with low PSA. This study evaluates the impact of PSMA-PET on recurrent post-prostatectomy patients treated with radiotherapy (RT) ± hormonal therapy (HT). Materials and methods:In a prospective, observational study (2016-2020), 103 hormone-sensitive post-prostatectomy pN0-pNx PCa patients with proven BCR were analyzed. PSMA-positive patients received tailored treatments based on lesion sites, ranging from prostate bed (P-bed) SRT abort, metastases-directed therapy, to systemic therapy. PSMA-negative patients were mainly treated with SRT. Primary objectives included PSMA-based management changes and biochemical progression-free survival (bPFS) comparison. Results:PSMA-PET was positive in 28.1% (29/103) at a median PSA of 0.5 ng/mL. The most common relapse sites were bones and pelvic lymph nodes. Among positive PSMA-PET patients, the P-bed abort rate was 58.6% (17/29 patients). Excluding patients with PSMA-positive uptake solely in the P-bed (7 patients), the rate of P-bed abort was 77.3% (17/22 patients). Management was altered in 75.8% of PSMA-positive and 21.3% overall. Most PSMA-positive lesions were managed with SBRT, either as a standalone treatment or within combined-modality approaches: SBRT was delivered to 50% of nodal recurrences (including both N1 and M1a cases) and to 100% of bone lesions. At 5 years, bPFS was 66.8% in PSMA-negative patients (undergoing SRT+/-HT) vs. 26.7% in PSMA-positive patients (any treatment). Conclusion:PSMA-PET led to management changes in nearly one-third of post-prostatectomy recurrent PCa, notably affecting RT strategies and systemic therapy. Emerging evidence suggests that treatment intensification based on PSMA-PET findings may improve patient outcomes compared to de-intensified approaches. The impact on outcomes awaits validation from ongoing prospective randomized trials.

Metastasis-directed therapy guided by gallium 68 ( 68 Ga) prostate-specific membrane antigen (PSMA)-11 PET/CT improved metastasis-free survival but not local recurrence-free survival compared with fluorine 18 ( 18 F)-PSMA-1007 and 18 F-fluorocholine PET/CT in patients with nodal or bone oligorecurrent prostate cancer.

We aimed to evaluate the prognostic impact of baseline clinical features and treatment procedure, including liver function measured with albumin–bilirubin (ALBI) formula and dosing methods in HCC patients treated with SIRT. The study includes 82 consecutive patients with liver-dominant HCC treated with SIRT (90Y glass microspheres, TheraSphereTM) between October 2014 and September 2023. Twenty-five patients were treated with standard dosimetry, while for remaining patients, multi-compartment dosimetry was performed using Simplicit90YTM software. Impact of baseline patient's characteristics including presence of portal vein thrombosis (PVT), Child–Pugh score (CP), ALBI score, bilirubin levels, tumor size and prior locoregional liver-directed or systemic treatments was assessed through multivariable Cox proportional hazard model. Median follow-up after treatment was 40.0 months (15.2–67.9). At univariable analysis, ALBI score and bilirubin levels were found to be independent prognostic factors for survival after SIRT (p = 0.001, respectively); furthermore, at Cox proportional hazards analysis, HR for death of ALBI 2 versus ALBI 1 was 10.54 (95

Metastasis-directed therapy (MDT) has been tested in clinical trials as a treatment option for oligorecurrent prostate cancer (PCa). However, there is an ongoing debate regarding the impact of using different imaging techniques interchangeably for defining lesions and guiding MDT within clinical trials. Methods: We retrospectively identified oligorecurrent PCa patients who had 5 or fewer nodal, bone, or visceral metastases detected by choline or prostate-specific membrane antigen (PSMA) PET/CT and who underwent MDT stereotactic body radiotherapy with or without systemic therapy in 8 tertiary-level cancer centers. Imaging-guided MDT was assessed as progression-free survival (PFS), time to systemic treatment change due to polymetastatic conversion (PFS2), and overall survival predictor. Propensity score matching was performed to account for clinical differences between groups. Results: Of 402 patients, 232 (57.7%) and 170 (42.3%) underwent MDT guided by [18F]fluorocholine and PSMA PET/CT, respectively. After propensity score matching, patients treated with PSMA PET/CT-guided MDT demonstrated longer PFS (hazard ratio [HR], 0.49 [95% CI, 0.36-0.67]; P < 0.0001), PFS2 (HR, 0.42 [95% CI, 0.28-0.63]; P < 0.0001), and overall survival (HR, 0.39 [95% CI, 0.15-0.99]; P < 0.05) than those treated with choline PET/CT-guided MDT. Additionally, we matched patients who underwent [68Ga]Ga-PSMA-11 versus [18F]F-PSMA-1007 PET/CT, observing longer PFS and PFS2 in the former subgroup (PFS: HR, 0.51 [95% CI, 0.26-1.00]; P < 0.05; PFS2: HR, 0.24 [95% CI, 0.09-0.60]; P < 0.05). Conclusion: Diverse imaging methods may influence outcomes in oligorecurrent PCa patients undergoing MDT. However, prospective, head-to-head studies, ideally incorporating a randomized design, are necessary to provide definitive evidence and facilitate the practical application of these findings.

La valutazione della risposta al trattamento con inibitori della tirosin-chinasi in pazienti con carcinoma tiroideo è argomento ampiamente dibattuto; negli ultimi anni la PET/CT sta dimostrando il suo ruolo fondamentale, in quanto la risposta metabolica al trattamento è spesso più precoce di quella morfologica, soprattutto in caso di utilizzo di farmaci citostatici. Questa rassegna ha lo scopo di riassumere le evidenze scientifiche sull’argomento.

This prospective study aimed to (1) compare the diagnostic performance of 68Ga-PSMA-11 PET/CT with respect to conventional imaging (computed tomography (CT) and bone scintigraphy (BS)) in the primary staging of high-risk prostate cancer (PCa) patients and (2) validate PSMA-PET/CT accuracy in pelvic nodal staging in comparison with postoperative histopathology and assess PSMA-PET/CT’s impact on patient management. Sixty castration-sensitive high-risk (ISUP 4–5 and/or PSA > 20 ng/mL and/or cT3) PCa patients eligible for radical prostatectomy were enrolled (median PSA 10.10 [IQR: 6.22–17.95] ng/mL). PSMA-PET/CT, compared with CT, identified nodal (N) and/or distant metastases (M1) in 56.7% (34/60) vs. 13.3% (8/60) (p < 0.001) of patients: N + 45% vs. 13.3% (p < 0.001), M1a 11.7% vs. 1.7% (p = 0.03), M1b 23.3% vs. 1.7% (p < 0.001). Compared with BS, PSMA-PET/CT localized unknown skeletal metastases in 15% (9/60) of cases, with no false negative findings. Overall, PSMA-PET/CT led to a TNM upstaging in 45.0% (27/60) of cases, with no evidence of downstaging, resulting in a change in management in up to 28.8% (17/59) of patients. Compared with histopathology data (n = 32 patients), the per-patient accuracy of PSMA-PET/TC for detecting pelvic nodal metastases was 90.6%. Overall, the above evidence supports the use of PSMA-PET/CT in the diagnostic workup of high-risk prostate cancer staging.

Purpose Prostate-Specific Membrane Antigen (PSMA)-targeted Positron Emission Tomography (PET) has revolutionised prostate cancer (PCa) diagnosis and treatment, offering superior diagnostic accuracy over traditional methods and enabling theragnostic applications. However, a significant diagnostic challenge has emerged with identifying unspecific bone uptakes (UBUs), which could lead to over-staging and inappropriate treatment decisions if misinterpreted. This systematic review explores the phenomenon of UBUs in PCa patients undergoing PSMA-PET imaging.Methods Studies assessing the prevalence, topographical distribution, and potential clinical implications of UBUs were selected according to the Preferred Reporting Items for a Systematic Review and Meta-Analysis (PRISMA) method and evaluated with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.Results The percentage of PCa patients with UBUs on PSMA-PET scans ranged from 0 to 71.7%, depending on the radiopharmaceutical used, with [18F]PSMA-1007 showing the highest incidence. The ribs are the primary site of UBUs across all PSMA-targeted radiopharmaceuticals. The spine is the second most frequent UBU site for [68Ga]Ga-PSMA-11, [18F]DCFPyL, [18F]rhPSMA-7, while the pelvic girdle represents the second most frequent site for [18F]PSMA-1007. The average maximum Standardized Uptake Value (SUVmax) of UBUs varied from 3.4 to 7.7 and was generally lower than that of bone metastases.Conclusions Our findings underscore the need for heightened awareness and precise interpretation of UBUs to avoid potential over-staging and subsequent inappropriate treatment decisions. Considering the radiopharmaceutical used, PET-derived semiquantitative parameters, the topographical distribution of UBUs, and accurately evaluating the pre-test probability based on clinical and laboratory parameters may aid nuclear medicine physicians in interpreting PSMA-PET findings.

The aim of this study was to investigate whether the favorable characteristics of novel digital PET/CT (dPET) scanners compared to analog systems (aPET) could translate into an improved disease localization in prostate cancer (PCa) patients with early biochemical recurrence/persistence (BCR/BCP). A retrospective analysis was conducted on 440 consecutive analog (n = 311) or digital (n = 129) 68Ga-PSMA-11 PET/CT scans performed in hormone-sensitive ADT-free PCa patients with early-BCR/BCP (PSA at PET ≤ 2.0 ng/mL), previously treated with radical intent (radical-prostatectomy/radiotherapy). dPET showed a higher positivity rate compared to aPET (48.8% [63/129] vs. 37.3% [116/311], p = 0.03), despite the slightly lower median PSA value of the dPET cohort (0.33 [IQR: 0.26–0.61] vs. 0.55 [IQR: 0.40–0.85] ng/mL, p < 0.01). dPET detection rate was higher in both PSA ranges 0.2–0.5 ng/mL (39.0% [32/82] vs. 25.2% [34/135], p = 0.03) and 0.5–1.0 ng/mL (63.2% [24/38] vs. 40.8% [53/130], p = 0.02), but not for PSA ≥ 1.0 ng/mL. dPET detected a higher per patient median number of pathologic findings (PSMA-RADS ≥ 3) and multi-metastatic cases (>3 lesions) among N1/M1-positive scans (21.7% [10/46] vs. 8.6% [9/105], p = 0.03). Moreover, the proportion of uncertain findings among pathological lesions was significantly lower for dPET than aPET (24.4% [39/160] vs. 38.5% [60/156], p = 0.008). Overall, 68Ga-PSMA-11 dPET showed a better performance compared to aPET, resulting in a higher scan-positivity rate, a higher number of detected pathological lesions, and a lower rate of uncertain findings.

You have accessJournal of UrologyCME1 Apr 2023V10-06 INTRAOPERATIVE USE OF PET/CT SPECIMEN IMAGER TO GUIDE ROBOTIC RADICAL PROSTATECTOMY AND PELVIC LYMPH NODE DISSECTION Marco Oderda, Serena Grimaldi, Giorgio Calleris, Daniele D'Agate, Federico Lavagno, Alessandro Marquis, Giancarlo Marra, Desireé Deandreis, and Paolo Gontero Marco OderdaMarco Oderda , Serena GrimaldiSerena Grimaldi , Giorgio CallerisGiorgio Calleris , Daniele D'AgateDaniele D'Agate , Federico LavagnoFederico Lavagno , Alessandro MarquisAlessandro Marquis , Giancarlo MarraGiancarlo Marra , Desireé DeandreisDesireé Deandreis , and Paolo GonteroPaolo Gontero View All Author Informationhttps://doi.org/10.1097/JU.0000000000003328.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Today, PSMA is the most accurate radiopharmaceutical in PCa and it can be used as a tracer to identify PCa foci in resected specimens. To do so, a small, high-resolution PET/CT-imaging device (XEOS AURA®) was developed, with near five-fold optimization in spatial resolution as opposed to the standard clinical PET/CT devices. Aim of this feasibility study was to test the intraoperative use of this brand-new PET/CT specimen imager to guide robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND). METHODS: To date, we performed three cases of RARP and PLND with intraoperative use of XEOS AURA® specimen imager. All patients underwent preoperative staging with MRI and PSMA PET/CT. Surgeries were performed with Da Vinci Xi robot. During trocar placement, an intravenous injection of 68-Ga PSMA, 2 mBq/kg, was performed. Lymph nodes were immediately removed through the 12-mm assistant trocar and inserted into the specimen imager for analysis. After complete excision, the prostate was removed through a short Pfannestiel incision while maintaining CO2 insufflation, and analysed with the specimen imager to check for positive margins (PSM) before doing the urethra-vesical anastomosis. RESULTS: On average, the time required by XEOS AURA® to analyse each specimen was 12 minutes (SD 3). Total and positive nodal yield were 17.3 (5.8) and 0.3 (0.5 SD), respectively. PET/CT specimen imager showed a marked uptake for the only positive node retrieved, and a diffuse, weak uptake in several negative nodes. There was a good correspondence between marked uptake and node positivity, reflecting also preoperative PET/CT findings (Table 1). XEOS AURA® was useful to predict negative surgical margins, although in one locally advanced case this evaluation was uncertain. CONCLUSIONS: The use of PET/CT specimen imager is safe and feasible. The intraoperative knowledge of prostate cancer (PCa) location within lymph nodes or inside the prostate is essential to improve the oncological radicality of the procedure while safely pushing the boundaries of a hyper-conservative surgery. Source of Funding: University of Turin © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e927 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Metrics Author Information Marco Oderda More articles by this author Serena Grimaldi More articles by this author Giorgio Calleris More articles by this author Daniele D'Agate More articles by this author Federico Lavagno More articles by this author Alessandro Marquis More articles by this author Giancarlo Marra More articles by this author Desireé Deandreis More articles by this author Paolo Gontero More articles by this author Expand All Advertisement PDF downloadLoading ...

BackgroundTuberous sclerosis complex (TSC) is a rare multisystemic disorder. This genetically determined disease is characterized by highly variable clinical expression, including epilepsy as a common feature. Seizures can also occur as a manifestation of symptomatic hypoglycemia. The latter could be caused by an insulinoma, whose association to TSC has already been debated. In TSC-associated tumors, dysregulation of the mTOR pathway is believed to be present, leading to significant impacts on cellular metabolism, growht, and proliferation. To date, the association between TSC and insulinoma has been reported in 11 adults. Here, we present the first case of a pediatric patient with TSC diagnosed with an insulinoma and review the existing literature on this topic.Case presentationA 11-year-old female with TSC presented with seizures unresponsive to standard therapy. Further investigation revealed that these seizures were caused by hypoglycemia. Subsequent evaluation led to the diagnosis of a pancreatic insulinoma, which was surgically removed. Following the procedure, the patient was free from seizures.ConclusionsIn individuals with TSC, the recurrence of epileptiform episodes throughout their lifetime, especially if previously well controlled with antiepileptic therapy, should raise suspicion for hypoglycemic events. These events may potentially be associated with the presence of an insulinoma. Further research and increased awareness are necessary to gain a better understanding of the association between TSC and insulinomas, and to guide clinical management strategies.

INTRODUCTION:The aim of this feasibility study was to test the intraoperative use of this brand-new specimen PET/CT to guide robot-assisted radical prostatectomy and pelvic lymph node dissection. MATERIALS AND METHODS:Three cases of robot-assisted radical prostatectomy and pelvic lymph node dissection were performed with intraoperative use of the specimen imager. Surgeries were performed with Da Vinci Xi robot. An intravenous injection of 68Ga-PSMA-11 was performed in the OR and after complete excision, the specimens were analyzed with the imager. RESULTS:The average nodal yield was 17.3 (5.8 SD) nodes per patient. Specimen PET/CT images showed a focal uptake in a metastatic node (TBR 13.6), and no uptake or diffuse, faint uptake in negative nodes (TBR range: 1-5.3). The specimen imager provided intraoperative PET/CT images that clearly showed negative surgical margins in two patients, whereas the results were uncertain in a locally advanced case. CONCLUSION:The intraoperative use of the specimen PET/CT imager is safe and feasible and could improve the evaluation of prostate surgical margins and lymph node status.

High-resolution intraoperative PET/CT specimen imaging, coupled with prostate-specific membrane antigen (PSMA) molecular targeting, holds great potential for the rapid ex vivo identification of disease localizations in high-risk prostate cancer patients undergoing surgery. However, the accurate analysis of radiotracer uptake would require time-consuming manual volumetric segmentation of 3D images. The aim of this study was to test the feasibility of using machine learning to perform automatic nodal segmentation of intraoperative 68Ga-PSMA-11 PET/CT specimen images. Six (n = 6) lymph-nodal specimens were imaged in the operating room after an e.v. injection of 2.1 MBq/kg of 68Ga-PSMA-11. A machine learning-based approach for automatic lymph-nodal segmentation was developed using only open-source Python libraries (Scikit-learn, SciPy, Scikit-image). The implementation of a k-means clustering algorithm (n = 3 clusters) allowed to identify lymph-nodal structures by leveraging differences in tissue density. Refinement of the segmentation masks was performed using morphological operations and 2D/3D-features filtering. Compared to manual segmentation (ITK-SNAP v4.0.1), the automatic segmentation model showed promising results in terms of weighted average precision (97–99%), recall (68–81%), Dice coefficient (80–88%) and Jaccard index (67–79%). Finally, the ML-based segmentation masks allowed to automatically compute semi-quantitative PET metrics (i.e., SUVmax), thus holding promise for facilitating the semi-quantitative analysis of PET/CT images in the operating room.

In prostate cancer (PCa), the use of new radiopharmaceuticals has improved the accuracy of diagnosis and staging, refined surveillance strategies, and introduced specific and personalized radioreceptor therapies. Nuclear medicine, therefore, holds great promise for improving the quality of life of PCa patients, through managing and processing a vast amount of molecular imaging data and beyond, using a multi-omics approach and improving patients' risk-stratification for tailored medicine. Artificial intelligence (AI) and radiomics may allow clinicians to improve the overall efficiency and accuracy of using these "big data" in both the diagnostic and theragnostic field: from technical aspects (such as semi-automatization of tumor segmentation, image reconstruction, and interpretation) to clinical outcomes, improving a deeper understanding of the molecular environment of PCa, refining personalized treatment strategies, and increasing the ability to predict the outcome. This systematic review aims to describe the current literature on AI and radiomics applied to molecular imaging of prostate cancer.

AimsTo perform a cost-effectiveness analysis (CEA) comparing personalised dosimetry with standard dosimetry in the context of selective internal radiation therapy (SIRT) with TheraSphere for the management of adult patients with locally advanced hepatocellular carcinoma (HCC) from the Italian Healthcare Service perspective.Materials and methodsA partition survival model was developed to project costs and the quality-adjusted life years (QALYs) over a lifetime horizon. Clinical inputs were retrieved from a published randomised controlled trial. Health resource utilisation inputs were extracted from the questionnaires administered to clinicians in three oncology centres in Italy, respectively. Cost parameters were based on Italian official tariffs.ResultsOver a lifetime horizon, the model estimated the average QALYs of 1.292 and 0.578, respectively, for patients undergoing personalised and standard dosimetry approaches. The estimated mean costs per patient were €23,487 and €19,877, respectively. The incremental cost-utility ratio (ICUR) of personalised versus standard dosimetry approaches was €5,056/QALY.ConclusionsPersonalised dosimetry may be considered a cost-effective option compared to standard dosimetry for patients undergoing SIRT for HCC in Italy. These findings provide evidence for clinicians and payers on the value of personalised dosimetry as a treatment option for patients with HCC.

Background/AimProstate-Specific-Membrane-Antigen/Positron Emission Tomography (PSMA-PET) detects with high accuracy disease-recurrence, leading to changes in the management of biochemically-recurrent (BCR) prostate cancer (PCa). However, data regarding the oncological outcomes of patients who performed PSMA-PET are needed. The aim of this study was to evaluate the incidence of clinically-relevant events during follow-up in patients who performed PSMA-PET for BCR after radical treatment. Materials and Methodsthis analysis included consecutive, hormone-sensitive, hormone-free, recurrent PCa patients (HSPC) enrolled through a prospective study. All patients were eligible for salvage therapy, having at least 24 months of follow-up after PSMA-PET. The primary endpoint was the Event-Free Survival (EFS), defined as the time between the PSMA-PET and the date of event/last follow-up. The Kaplan-Meier method was used to estimate the EFS curves. EFS was also investigated by Cox proportional hazards regression. Events were defined as: death, radiological progression or PSA recurrence after therapy. ResultsOne-hundred and seventy-six (n=176) patients were analyzed (median PSA 0.62 [IQR:0.43–1.00] ng/mL; median follow-up of 35.4 [IQR:26.5-40.3] months). The EFS was 78.8% at one year, 65.2% (2-years), and 52.2% (3-years). Patients with clinically relevant events had a significantly higher median PSA (0.81 [IQR:0.53-1.28] vs 0.51 [IQR:0.36-0.80] ng/mL) and a lower PSAdt (5.4 [IQR:3.7-11.6] vs 12.7 [IQR:6.6-24.3] months) (p<0,001) compared to event-free patients. The Kaplan-Meier curves showed that PSA>0.5 ng/mL, PSAdt≤6 months and a positive PSMA-PET result were associated with a higher event rate (p<0.01). No significant differences of event rates were observed in patients who received changes in therapy management after PSMA-PET vs. patients who did not receive therapy changes. Finally, PSA> 0.5 ng/mL and PSAdt≤ 6months were statistically significant event-predictors in multi-variate model (p<0.001). ConclusionIn this cohort of HSPC patients prospectively enrolled, low PSA and long PSAdt were significant predictors of event. Furthermore, a lower incidence of events was observed also in patients having negative PSMA-PET, since longer EFS was significantly more probable in case of a negative scan.