Dataset Information

Prospective, Multisite, International Comparison of 18F-Fluoromethylcholine PET/CT, Multiparametric MRI, and 68Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes.

ABSTRACT: A significant proportion of men with rising prostate-specific antigen (PSA) levels after radical prostatectomy (RP) fail prostate fossa (PF) salvage radiation treatment (SRT). This study was done to assess the ability of 18F-fluoromethylcholine (18F-FCH) PET/CT (hereafter referred to as 18F-FCH), 68Ga-HBED-CC PSMA-11 PET/CT (hereafter referred to as PSMA), and pelvic multiparametric MRI (hereafter referred to as pelvic MRI) to identify men who will best benefit from SRT. Methods: Prospective, multisite imaging studies were carried out in men who had rising PSA levels after RP, high-risk features, and negative/equivocal conventional imaging results and who were being considered for SRT. 18F-FCH (91/91), pelvic MRI (88/91), and PSMA (31/91) (Australia) were all performed within 2 wk. Imaging was interpreted by experienced local/central interpreters who were masked with regard to other imaging results, with consensus being reached for discordant interpretations. Expected management was documented before and after imaging, and data about all treatments and PSA levels were collected for 3 y. The treatment response to SRT was defined as a reduction in PSA levels of >50% without androgen deprivation therapy. Results: The median Gleason score, PSA level at imaging, and PSA doubling time were 8, 0.42 (interquartile range, 0.29-0.93) ng/mL, and 5.0 (interquartile range, 3.3-7.6) months. Recurrent prostate cancer was detected in 28% (25/88) by pelvic MRI, 32% (29/91) by 18F-FCH, and 42% (13/31) by PSMA. This recurrence was found within the PF in 21.5% (19/88), 13% (12/91), and 19% (6/31) and at sites outside the PF (extra-PF) in 8% (7/88), 19% (17/91), and 32% (10/31) by MRI, 18F-FCH, and PSMA, respectively (P < 0.004). A total of 94% (16/17) of extra-PF sites on 18F-FCH were within the pelvic MRI field. Intrapelvic extra-PF disease was detected in 90% (9/10) by PSMA and in 31% (5/16) by MRI. 18F-FCH changed management in 46% (42/91), and MRI changed management in 24% (21/88). PSMA provided additional management changes over 18F-FCH in 23% (7/31). The treatment response to SRT was higher in men with negative results or disease confined to the PF than in men with extra-PF disease (18F-FCH 73% [32/44] versus 33% [3/9] [P < 0.02], pelvic MRI 70% [32/46] versus 50% [2/4] [P was not significant], and PSMA 88% [7/8] versus 14% [1/7] [P < 0.005]). Men with negative imaging results (MRI, 18F-FCH, or PSMA) had high (78%) SRT response rates. Conclusion: 18F-FCH and PSMA had high detection rates for extra-PF disease in men with negative/equivocal conventional imaging results and rising PSA levels after RP. These findings affected management and treatment responses, suggesting an important role for PET in triaging men being considered for curative SRT.

SUBMITTER: Emmett L

PROVIDER: S-EPMC6581227 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Prospective, Multisite, International Comparison of 18F-Fluoromethylcholine PET/CT, Multiparametric MRI, and 68Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes.

Emmett Louise L Metser Ur U Bauman Glenn G Hicks Rodney J RJ Weickhardt Andrew A Davis Ian D ID Punwani Shonit S Pond Greg G Chua Sue S Ho Bao B Johnston Edward E Pouliot Frederic F Scott Andrew M AM

Journal of nuclear medicine : official publication, Society of Nuclear Medicine 20181115 6

A significant proportion of men with rising prostate-specific antigen (PSA) levels after radical prostatectomy (RP) fail prostate fossa (PF) salvage radiation treatment (SRT). This study was done to assess the ability of 18F-fluoromethylcholine (18F-FCH) PET/CT (hereafter referred to as 18F-FCH), 68Ga-HBED-CC PSMA-11 PET/CT (hereafter referred to as PSMA), and pelvic multiparametric MRI (hereafter referred to as pelvic MRI) to identify men who will bes ...[more]

PMID: 30442757

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Project description:Background: By targeting the prostate-specific membrane antigen (PSMA) on prostate cancer (PCa) cells PSMA-PET/CT shows great potential in locating the site of biochemical recurrence even at low PSA (Prostate-specific antigen)-levels. Accurate imaging of PCa recurrent lymph node metastases (LNM) is crucial for metastases directed therapies such as salvage-lymph node dissection (salvage-LND). Objective: To evaluate the diagnostic accuracy of PSMA-PET/CT for detection of affected lymph-node regions at salvage-LND for nodal recurrence of PCa. Design, setting and participants: 30 patients with the suspicion of exclusively nodal PCa-relapse after primary therapy underwent a template pelvic and/or retroperitoneal salvage-LND after whole body 68-Ga-PSMA-PET/CT. The diagnostic accuracy of PET/CT was evaluated in comparison to the histopathology of 965 resected lymph nodes (LN) dissected from 68 main regions (pelvic left/right, retroperitoneal) and 289 subregions (common iliac, external iliac, obturator, internal iliac, presacral, aortic-bifurcation, aortal, caval). LNM and tumor deposits in LNM were measured bidimensionally in the histopathology. PSMA-expression was analyzed by immunohistochemistry in LNM. Results: LNM were present in 11.4% of the resected LN (110/965) resulting in 45 positive main regions and 85 positive subregions. PET/CT was true positive in 41 main regions and 69 subregions. Three PET-negative main regions and 16 PET-negative subregions finally contained LNM, the majority of these false negative subregions (13/16) were in neighboring regions of true-positive subregions. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were: main region-based 93.2%, 100%, 100%, 88.9% and 95.6%, subregion-based 81.2%, 99.5%, 98.6%, 92.7 and 94.1%. Median short diameters of tumor deposits in LNM resected from false-negative subregions (1.3 mm) were significantly smaller than in LNM removed from true-positive subregions (5.5 mm, p<0.0001). Based on anatomical subregions containing just one LNM, the necessary short diameter of tumor deposits in LNM required to reach a detection rate of 50% and 90% was estimated to be ? 2.3 mm and ? 4.5 mm, respectively. Conclusion: In men with biochemical PCa-relapse and positive PSMA-PET/CT, PET/CT detects metastatic affected anatomical regions with high accuracy at a main region and at a subregion-level. If the decision for salvage-LND is prompted by a positive PSMA-PET/CT, the size of metastases is crucial for accurate detection of affected regions. All LNM showed a clear PSMA-expression in the immunohistochemistry. Further studies need to investigate how to translate the high anatomical correlation observed between PET/CT and surgical findings into optimal approaches for target salvage-LND.

Project description:PurposeSince the introduction of positron emission tomography (PET) imaging with (68)Ga-PSMA-HBED-CC (=(68)Ga-DKFZ-PSMA-11), this method has been regarded as a significant step forward in the diagnosis of recurrent prostate cancer (PCa). However, published data exist for small patient cohorts only. The aim of this evaluation was to analyse the diagnostic value of (68)Ga-PSMA-ligand PET/CT in a large cohort and the influence of several possibly interacting variables.MethodsWe performed a retrospective analysis in 319 patients who underwent (68)Ga-PSMA-ligand PET/CT from 2011 to 2014. Potential influences of several factors such as prostate-specific antigen (PSA) level and doubling time (DT), Gleason score (GSC), androgen deprivation therapy (ADT), age and amount of injected tracer were evaluated. Histological verification was performed in 42 patients after the (68)Ga-PSMA-ligand PET/CT. Tracer uptake was measured in 901 representative tumour lesions.ResultsIn 82.8% of the patients at least one lesion indicative of PCa was detected. Tumor-detection was positively associated with PSA level and ADT. GSC and PSA-DT were not associated with tumor-detection. The average maximum standardized uptake value (SUVmax) of tumour lesions was 13.3 ± 14.6 (0.7-122.5). Amongst lesions investigated by histology, 30 were false-negative in 4 different patients, and all other lesions (n = 416) were true-positive or true-negative. A lesion-based analysis of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) revealed values of 76.6%, 100%, 91.4% and 100%. A patient-based analysis revealed a sensitivity of 88.1%. Of 116 patients available for follow-up, 50 received local therapy after (68)Ga-PSMA-ligand PET/CT.Conclusion(68)Ga-PSMA-ligand PET/CT can detect recurrent PCa in a high number of patients. In addition, the radiotracer is highly specific for PCa. Tumour detection is positively associated with PSA and ADT. (68)Ga-PSMA-ligand PET/CT can help delay systemic therapy of PCa.

Project description:Accurate detection of prostate cancer lymph node metastases (LNM) through PET/CT before lymphadenectomy is crucial for successful therapy. PET/CT with choline derivatives used to be the standard tool for imaging metastases, whereas 68Ga-PSMA (prostate-specific membrane antigen) PET/CT was introduced recently. Both PET techniques were investigated with respect to what extent the detection rate of LNM depends on the size of tumor deposits (TDs) within LNM. Methods: Documenting the switch from the use of 18F-choline to 68Ga-PSMA in 2014, we used 2 patient cohorts undergoing a template lymphadenectomy because of a PET/CT indicating LNM. Forty-four and 40 patients underwent PET/CT with 18F-choline or 68Ga-PSMA ligand, respectively. In total, 226 LNM (125 18F-choline, 101 68Ga-PSMA) originated from 73 salvage lymphadenectomies at biochemical recurrence and from 11 primary lymphadenectomies at radical prostatectomy. LNM eligible for direct correlation of PET/CT to histopathology were identified from lymphadenectomies conducted in small anatomic subregions, with 1 LNM (condition 1) or 1-2 LNM (condition 2). Longitudinal and short diameters of TD within LNM were determined by histopathology, allowing linking of the size of TD in LNM to the detection threshold of PET/CT. Diameters associated with a detection rate of 50% and 90% (d50%, d90%) were calculated on the basis of logistic growth curve models fitted. Results: Gleason score, number of removed LNs, and subregions for lymphadenectomy per patient did not differ significantly between the 18F-choline and 68Ga-PSMA groups. The median prostate-specific antigen level at imaging and number of LNM per patient were significantly higher in the 18F-choline group (3.4 ng/mL, n = 34) than in the 68Ga-PSMA group (2.2 ng/mL, n = 28; both P < 0.05). Longitudinal and short diameters of TD in LNM to reach d90% were 11.2 and 7.4 mm, respectively, for 18F-choline PET/CT and 6.3 and 4.9 mm, respectively, for 68Ga-PSMA PET/CT. Corresponding diameters to reach d50% were 5.5 and 3.3 mm, respectively, for 18F-choline PET/CT and 3.7 and 2.3 mm, respectively, for 68Ga-PSMA PET/CT. Detection rates were significantly higher under 68Ga-PSMA (P = 0.005 and 0.04 for longitudinal and short diameter). Conclusion: 68Ga-PSMA PET/CT is superior to 18F-choline PET/CT in the detection of LNM. Whether those results will lead to an improved patient outcome after 68Ga-PSMA PET-guided therapy needs to be investigated by further studies.

Project description:BackgroundThere are some limitations in the commonly used methods for the detection of prostate cancer. There is a lack of nomograms based on multiparametric magnetic resonance imaging (mpMRI) and 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT) for the prediction of prostate cancer. The study seeks to compare the performance of mpMRI and 68Ga-PSMA PET-CT, and design a novel predictive model capable of predicting clinically significant prostate cancer (csPCa) before biopsy based on a combination of 68Ga-PSMA PET-CT, mpMRI, and patient clinical parameters.MethodsFrom September 2020 to June 2021, we prospectively enrolled 112 consecutive patients with no prior history of prostate cancer who underwent both 68Ga-PSMA PET-CT and mpMRI prior to biopsy at our clinical center. Univariate and multivariate regression analyses were used to identify predictors of csPCa, with a predictive model and its nomogram incorporating 68Ga-PSMA PET-CT, mpMRI, and the clinical predictors then being generated. The constructed model was evaluated using receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis, and further validated with the internal and external cohorts.ResultsThe model incorporated prostate-specific antigen density (PSAd), Prostate Imaging Reporting and Data System (PI-RADS) category, and maximum standardized uptake value (SUVmax), and it exhibited excellent predictive efficacy when applying to evaluate both training and validation cohorts [area under the curve (AUC): 0.936 and 0.940, respectively]. Compared with SUVmax alone, the model demonstrated excellent diagnostic performance with improved specificity (0.910, 95% CI: 0.824-0.963) and positive predictive values (0.811, 95% CI: 0.648-0.920). Calibration curve and decision curve analysis further confirmed that the model exhibited a high degree of clinical net benefit and low error rate.ConclusionsThe constructed model in this study was capable of accurately predicting csPCa prior to biopsy with excellent discriminative ability. As such, this model has the potential to be an effective non-invasive approach for the diagnosis of csPCa.

Project description:PurposeTo assess 68Ga-PSMA PET/CT for detection of low- and intermediate-risk prostate cancer (PCa), high-risk PCa in comparison with mpMRI, respectively, and to determine which of low- and intermediate-risk PCa are more likely to be detected by 68Ga-PSMA PET/CT.MethodsWe conducted a retrospective analysis of patients who had undergone a prostate biopsy and/or radical prostatectomy and who were scanned with 68Ga-PSMA PET/CT and mpMRI between June 2019 and March 2021. The mpMRI images were scored with the Prostate Imaging-Reporting and Data System Version 2.1 (PI-RADS) and were classified as either negative (PI-RADS 1-3) or positive (PI-RADS 4-5). Suspicious 68Ga-PSMA PET/CT lesions were reviewed for each relevant patient and classified by double-trained board-certified nuclear medicine physicians. The results were evaluated with the histopathological outcome. All patients were classified according to the D'Amico classification, and the clinical data were combined for stratified analysis.ResultA total of 101 patients who were pathologically diagnosed with PCa were analyzed. Of the 101 patients, 88 (80.6%) patients presented with a pathologic mpMRI, and 85 (79.1%) with a pathologic 68Ga-PSMA PET/CT. In the high-risk PCa cohort, 68Ga-PSMA PET/CT was positive in 64/66 (97.0%) patients and yielded a higher detection rate than that for the mpMRI patients (58/66, 87.9%; p < 0.05). However, mpMRI provided superior diagnostic confidence in identifying low- and intermediate-risk PCa (30/35, 85.7% vs. 21/35, 60.0%; p < 0.05). When the age threshold exceeded 62.5 years and the serum prostate specific antigen (PSA) threshold exceeded 9.4 ng/ml, a higher uptake of PSMA was more likely to occur in the lesions of low- and intermediate-risk PCa.ConclusionThe diagnostic performance of 68Ga-PSMA PET/CT was superior to that of mpMRI in the high-risk PCa cohort, which was consistent with prior studies. Furthermore, in the initial diagnosis of low- and intermediate-risk PCa, we found that mpMRI showed a higher diagnostic accuracy than 68Ga-PSMA PET/CT did. Low- and intermediate-risk PCa patients with a PSA ≥ 9.4 ng/ml and age ≥ 62.5 years were more likely to have a positive 68Ga-PSMA PET/CT result.

Dataset Information

Prospective, Multisite, International Comparison of 18F-Fluoromethylcholine PET/CT, Multiparametric MRI, and 68Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes.

Publications

Prospective, Multisite, International Comparison of <sup>18</sup>F-Fluoromethylcholine PET/CT, Multiparametric MRI, and <sup>68</sup>Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes.

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