Multisite experience of fluciclovine (18F) PET/CT imaging in biochemically recurrent prostate cancer: Impact of clinical factors and intersite variation.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 163-163
Author(s):  
Lucia Zanoni ◽  
Christina Nanni ◽  
Tore Bach-Gansmo ◽  
Trond V Bogsrud ◽  
Peter Nieh ◽  
...  

163 Background: Fluciclovine (18F) is an FDA-approved positron emission tomography/computerized tomography (PET/CT) tracer in clinical use for the detection and localization of biochemically recurrent (BCR) prostate cancer. Here, we report the impact of clinical factors and study site on its performance. Methods: In total, 596 subjects with BCR prostate cancer underwent fluciclovine (18F) PET/CT scanning at four sites in Italy, Norway and USA. Detection Rates (DR), including region level analyses, were stratified by prostate specific antigen (PSA) levels, PSA doubling time (PSAdt), Gleason score (GS), and by investigator/site. Extra-prostatic disease was defined as all positivity outside of residual prostate, prostate bed and seminal vesicles. Results: Fluciclovine (18F) PET/CT was positive in 67.7% (403/595) of subjects. Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232/599) and 32.6% (194/596) of scans, respectively. Metastatic involvement outside the pelvis was found in 26.2% (155/591) of scans. Generally, DR increased with increasing baseline PSA (Table 1). While subject level DR did not vary significantly with PSAdt (DR = 60-69% across all categories), a positive extra-prostatic scan was more likely in patients with shorter PSAdt (DR = 52%, 48%, 37% and 28% for PSAdt <3, 3-<6, 6-<12 and >12 months, respectively). Among 361 subjects for whom baseline GS was available, scores ≥9 were associated with the highest extra-prostatic DR (55%) compared with 23% in patients with GS ≤6. Inter-site variations in acquisition protocols may have impacted DR at low baseline PSA values; with subject level DR at PSA >0.2-0.5 ng/ml = 20%, 38%, 46% and 73% at site A, B, C and D, respectively. Conclusions: Fluciclovine (18F) can detect and localize BCR prostate cancer in a wide range of subjects and, with appropriate imaging protocols, has a clinically useful DR at PSA <0.5 ng/ml. Clinical trial information: NCT02443571. [Table: see text]

Author(s):  
Gesislania De Sousa ◽  
Erik Lima ◽  
Felipe Favaro Capeleti ◽  
Rafael Eidi Goto ◽  
Homero José de Farias e Melo ◽  
...  

Introdução: O Câncer de Próstata (CP) é o tumor maligno mais comum na população masculina acima dos 50 anos, sendo o adenocarcinoma o tipo histológico responsável por cerca de 95% dos casos. É o terceiro câncer com maior taxa de mortalidade entre os homens no mundo. A recorrência bioquímica do CP após prostatectomia radical é um problema clínico relevante. Objetivo: essa revisão teve como objetivo descrever o uso PET/CT-PSMA-68Ga no reestadiamento do CP nos casos de recidiva bioquímica após prostatectomia. Método: realizamos uma revisão bibliográfica na base de dados da PubMed, nos últimos três anos, de artigos publicados na íntegra. Resultados: Treze artigos foram usados na análise, a média da taxa de positividade do PET entre os estudos foi de 67.9%, variando de 34.4% a 89.5%. Discussão: todos os estudos concordam que maiores taxas de detecção foram diretamente proporcionais aos valores de PSA. Sete artigos mensuraram o impacto do PSMA na mudança terapêutica com uma média de 66.5% de alteração do tratamento (de 28.6% a 87.7%). Conclusão: Com base na análise dos artigos concluiu-se que o PET/CT-PSMA- - 68Ga na recorrência bioquímica do CP é útil na detecção de lesões locais e/ou metastáticas, e ainda importante no reestadiamento contribuindo nas decisões terapêuticas futuras.Palavras chave: Neoplasia prostática, Tomografia computadorizada, Recorrência, Bioquímica, PET/CT, Antígeno prostático específico Introduction: Prostate cancer (CP) is the most common malignant tumor in the male population over 50 years old, with adenocarcinoma being the histological type responsible for about 95% of cases. It is the third cancer with the highest mortality rate among men in the world. Biochemical recurrence of PC after radical prostatectomy is a relevant clinical problem. Objective: this review aimed to define the use of PET / CT-PSMA-68Ga without PC restaging in cases of biochemical recurrence after prostatectomy. Method: we performed a bibliographic review in the PubMed database, in the three years, of articles published in full. Results: Thirteen articles were used in the analysis, the average PET positivity rate between studies was 67.9%, varying from 34.4% to 89.5%. Discussion: all studies agree that higher detection rates were directly proportional to the PSA values. Seven articles measured the impact of PSMA on therapeutic change with an average of 66.5% of treatment change (from 28.6% to 87.7%). Conclusion: Based on the analysis of the concluded articles, PET / CT-PSMA-68Ga in the biochemical recurrence of PC is useful in the detection of sites and / or metastases, and also important in restaging, contributing to future therapeutic decisions. Keywords: Prostatic neoplasms, Computed tomography, Recurrence, Biochemistry, PET/CT, Prostate-specific antigen


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 231-231
Author(s):  
Helen Y Hougen ◽  
Nadine Mallak ◽  
Yiyi Chen ◽  
Catherine Degnin ◽  
Ryan P Kopp ◽  
...  

231 Background: The 18F-Fluciclovine (FACBC) PET/CT scan has higher sensitivity than traditional imaging modalities for detection of prostate cancer (PCa) recurrence. We aim to identify the PSA characteristics as predictors of positive FACBC scan. Methods: Seventy-eight patients who underwent FACBC scan in 2018 at our institution were identified. Patient demographics, prior PSA, clinical information including prior treatment was recorded. Scans were deemed positive if definitive lesions were noted at the prostate bed, pelvic lymph nodes, or skeletal level. Detection rate was the ratio of positive over total scans and was calculated for PSA ranges. PSA velocity (PSAV) was calculated for patients who did not initiate androgen-deprivation therapy 12 months prior to the scan. The baseline PSA and PSAV were modeled as predictors of having a positive scan using logistic regression. Results: The median baseline PSA is 2.7 (range 0.2 - 226.5). The rates of positivity increased with increasing baseline PSA (Table 1). Positive scans had higher median baseline PSA (3.0, range 0.2-226.5 vs. 1.2, range 0.2-26.0; p = 0.0015) and higher PSAV (median 2.3, range -0.6-1478.7 vs. 1.0, range -0.5-31.9; p = 0.025). Baseline PSA (AUC = 0.712) was better predictor than PSAV (AUC = 0.656) of a positive scan. Combining the two variables does not improve their predictive ability (AUC = 0.719). There is a 50% detection rate in post-radical prostatectomy (RP) patients (Table 2). Conclusions: FACBC PET’s detection rate increases with increasing baseline PSA. While higher PSAV is associated with higher rate of positive scan, it did not increase the predictive ability of baseline PSA for a positive scan in prostate cancer recurrence patients. [Table: see text][Table: see text]


2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Benjamin H. Lowentritt ◽  
Michael S. Kipper

The positron emission tomography (PET) tracer 18F-fluciclovine has seen increasing use to localize disease in men with biochemical recurrence of prostate cancer, i.e., elevated prostate-specific antigen (PSA) levels post-treatment. 18F-Fluciclovine PET/computed tomography (CT) imaging reports now play central roles in many physician-patient discussions. However, because no standardized grading system or templates yet exist for 18F-fluciclovine image assessment, reports vary in format, comprehensiveness, and terminology and may be challenging to fully understand. To better utilize these documents, referring physicians should be aware of six key features of 18F-fluciclovine PET/CT. First, 18F-fluciclovine is a radiolabeled synthetic amino acid targeting the amino acid transporters ASCT2 and LAT1, which are ubiquitous throughout the body, but overexpressed in prostate cancer. Second, 18F-fluciclovine image interpretation is predominantly visual/qualitative: radiotracer uptake in suspicious lesions is compared with uptake in bone marrow or blood pool. Location of 18F-fluciclovine-avid lesions relative to typical recurrence sites and findings elsewhere in the patient are considered when evaluating lesions’ probability of malignancy, as is visibility on maximum intensity projection images when assessing bone lesions. Third, 18F-fluciclovine PET/CT detection rates increase as PSA levels rise. Fourth, detection rates may differ among centers, possibly due to equipment and reader experience. Fifth, since no diagnostic test is 100% accurate, scan data should not be used in isolation. Lastly, 18F-fluciclovine PET/CT findings frequently induce changes in disease management plans. In the prospective multicenter LOCATE and FALCON studies, scans altered management plans in 59% (126/213) and 64% (66/104) of patients, respectively; 78% (98/126) and 65% (43/66) of changes, respectively, involved modality switches. Referring physicians and imagers should collaborate to improve scan reports. Referrers should clearly convey critical information, including prescan PSA levels, and open clinical questions. Imagers should produce reports that read like consultations, avoid leaving open questions, and if needed, provide thoughts on next diagnostic steps.


2020 ◽  
Vol 10 ◽  
Author(s):  
Kirsten Margrete Selnæs ◽  
Brage Krüger-Stokke ◽  
Mattijs Elschot ◽  
Håkon Johansen ◽  
Per Arvid Steen ◽  
...  

ObjectiveSimultaneous PET/MRI combines soft-tissue contrast of MRI with high molecular sensitivity of PET in one session. The aim of this prospective study was to evaluate detection rates of recurrent prostate cancer by 18F-fluciclovine PET/MRI.MethodsPatients with biochemical recurrence (BCR) or persistently detectable prostate specific antigen (PSA), were examined with simultaneous 18F-fluciclovine PET/MRI. Multiparametric MRI (mpMRI) and PET/MRI were scored on a 3-point scale (1-negative, 2-equivocal, 3-recurrence/metastasis) and detection rates (number of patients with suspicious findings divided by total number of patients) were reported. Detection rates were further stratified based on PSA level, PSA doubling time (PSAdt), primary treatment and inclusion criteria (PSA persistence, European Association of Urology (EAU) Low-Risk BCR and EAU High-Risk BCR). A detailed investigation of lesions with discrepancy between mpMRI and PET/MRI scores was performed to evaluate the incremental value of PET/MRI to mpMRI. The impact of the added PET acquisition on further follow-up and treatment was evaluated retrospectively.ResultsAmong patients eligible for analysis (n=84), 54 lesions were detected in 38 patients by either mpMRI or PET/MRI. Detection rates were 41.7% for mpMRI and 39.3% for PET/MRI (score 2 and 3 considered positive). There were no significant differences in detection rates for mpMRI versus PET/MRI. Disease detection rates were higher in patients with PSA≥1ng/mL than in patients with lower PSA levels but did not differ between patients with PSAdt above versus below 6 months. Detection rates in patients with primary radiation therapy were higher than in patients with primary surgery. Patients categorized as EAU Low-Risk BCR had a detection rate of 0% both for mpMRI and PET/MRI. For 15 lesions (27.8% of all lesions) there was a discrepancy between mpMRI score and PET/MRI score. Of these, 10 lesions scored as 2-equivocal by mpMRI were changed to a more definite score (n=4 score 1 and n=6 score 3) based on the added PET acquisition. Furthermore, for 4 of 10 patients with discrepancy between mpMRI and PET/MRI scores, the added PET acquisition had affected the treatment choice.ConclusionCombined 18F-fluciclovine PET/MRI can detect lesions suspicious for recurrent prostate cancer in patients with a range of PSA levels. Combined PET/MRI may be useful to select patients for appropriate treatment, but is of limited use at low PSA values or in patients classified as EAU Low-Risk BCR, and the clinical value of 18F-fluciclovine PET/MRI in this study was too low to justify routine clinical use.


2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Valeria Panebianco ◽  
Flavio Barchetti ◽  
Daniela Musio ◽  
Francesca De Felice ◽  
Camilla Proietti ◽  
...  

Currently the diagnosis of local recurrence of prostate cancer (PCa) after radical prostatectomy (RT) is based on the onset of biochemical failure which is defined by two consecutive values of prostate-specific antigen (PSA) higher than 0.2 ng/mL. The aim of this paper was to review the current roles of advanced imaging in the detection of locoregional recurrence. A nonsystematic literature search using the Medline and Cochrane Library databases was performed up to November 2013. Bibliographies of retrieved and review articles were also examined. Only those articles reporting complete data with clinical relevance for the present review were selected. This review article is divided into two major parts: the first one considers the role of PET/CT in the restaging of PCa after RP; the second part is intended to provide the impact of multiparametric-MRI (mp-MRI) in the depiction of locoregional recurrence. Published data indicate an emerging role for mp-MRI in the depiction of locoregional recurrence, while the performance of PET/CT still remains unclear. Moreover Mp-MRI, thanks to functional techniques, allows to distinguish between residual glandular healthy tissue, scar/fibrotic tissue, granulation tissue, and tumour recurrence and it may also be able to assess the aggressiveness of nodule recurrence.


Author(s):  
A. L. Dolbov ◽  
A. A. Stanjevskiy ◽  
D. N. Maistrenko ◽  
M. I. Shkolnik ◽  
А. Yu. Pakhomov ◽  
...  

Relevance: Prostate cancer is one of the most frequently diagnosed malignant neoplasms of the genitourinary system in men in the world. Recently, there has been an active introduction into clinical practice of positron emission tomography technology combined with computed tomography (PET/CT) with 68Ga‑PSMA‑617 based on prostate‑specific membrane antigen (PSMA), the capabilities of which significantly increase the effectiveness of the diagnosis of prostate cancer at various clinical stages compared with routine methods used in the staging of prostate cancer.Purpose: To compare the diagnostic effectiveness of PET/CT with 68Ga‑PSMA‑617 with traditional methods of radiation imaging (computed tomography, magnetic resonance imaging and bone scan) in the staging of prostate cancer and to clarify the impact of this technology on the choice of surgical treatment.Material and methods: PET/CT with 68Ga‑PSMA was performed in our center in order to stage the verified prostate cancer in 109 patients aged 48 to 80 years (median 64.5). The selection criteria were: a PSA level of more than 5 ng/ml, the presence of a newly identified, histologically verified prostate cancer, lack of treatment, suspicion of metastatic lesion of the lymph nodes of the pelvis and skeleton. Patients were divided into groups by prostate‑specific antigen level, Gleason score, and d’Amico.Results: In the analysis of PET/CT results and MRI/CT comparison and Bone scan, 56 (51.4 %) of 109 patients showed a change in the TNM stage. A change in the data on the local spread of the tumor with an increase in the stage according to criterion T due to the detection of pathological accumulation of RFP in seminal vesicles was detected in 21 (37.5 %) of 56 patients. Additionally, according to PET/CT data, 13 (23.2 %) of 56 patients were found to have lesions of regional lymph nodes (N). Metastatic lesions of distant lymph nodes (M1a) and bones (M1b), not visualized during routine radiation examination, were observed in 32 (57.1 %) and 36 (64.3 %) of 56 patients, respectively.Conclusions: The use of PET/CT 68Ga‑PSMA‑617 in patients with newly diagnosed prostate cancer at the staging stage allows us to obtain valuable additional information about the local, regional and long‑term prevalence of the pathological process, and in some cases — to change the stage of the disease by TNM (usually by increasing it), which has a significant impact on the tactics of therapeutic measures and the choice of the optimal method of therapy for prostate cancer.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 248-248
Author(s):  
Michael S Kipper ◽  
Paul Dato ◽  

248 Background: Bone is the most frequent site of metastasis in prostate cancer. Accurate localization of recurrence following primary treatment can help optimize salvage therapy. Positron emission tomography (PET) tracer, 18F-fluciclovine, is approved in Europe and the US for men with rising prostate specific antigen (PSA) after prior treatment. LOCATE was a prospective trial to study the impact of 18F-fluciclovine PET/computed tomography (PET/CT) on management of men with prostate cancer recurrence and negative standard imaging after curative intent treatment. Here, we explore changes in management (CIM) in men with 18F-fluciclovine-avid bone lesions. Methods: 18F-Fluciclovine PET/CT was performed and interpreted according to standard practice at 15 US centers. Eligible men (≥ 18 y; prior curative intent treatment of prostate cancer; recurrence based on rising PSA; negative/equivocal findings on standard bone and pelvic imaging) had their treatment plans recorded pre- and post-scan. Results: A total of 213 men (median pre-scan PSA, 1.0 ng/mL) were enrolled. Overall, 18F-fluciclovine detected lesions in 122 (57%) and 126 (59%) had CIM post-scan. 18F-Fluciclovine-avid bone lesions were found in 23 (11%) men. Prior to the fluciclovine scan, 21 (91%) had a 99mTc-MDP scan (20 negative, 1 equivocal results), 1 (4%) had an unspecified bone scan (negative result) and 1 (4%) did not receive a bone-specific scan. Of the 23 men with positive scans, 15 (65%) had post-scan CIM: ADT added to planned radiotherapy (RT; 4, 27%); ADT replaced with targeted treatment of fluciclovine-positive extrapelvic bony areas (4, 27%); RT modified to target fluciclovine-positive areas (4, 27%); modified ADT regime (2, 13%); and watchful waiting in favor of RT (1, 7%). The majority of men with no post-scan CIM were prescribed ADT (6/8, 75%). Conclusions: Despite negative standard bone imaging,18F-fluciclovine localized recurrence of prostate cancer to bone in 11% of patients; the majority of whom had a management change as a result, frequently in order to target fluciclovine-positive sites. Further study to investigate the clinical outcomes of such changes is warranted. Clinical trial information: NCT02680041.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5556-5556
Author(s):  
Hong Song ◽  
Heying Duan ◽  
Caitlyn Harrison ◽  
Kip Guja ◽  
Negin Hatami ◽  
...  

5556 Background: 18F-DCFPyL, a promising PET agent targeting prostate specific membrane antigen (PSMA), is prospectively evaluated in a single academic center for detecting recurrent lesions in prostate cancer patients with biochemical recurrence (BCR). Methods: We prospectively enrolled 150 men (51-91 years old, mean ± SD: 70.3±7.5) with biochemical recurrence (PSA median 2.38 ng/mL, range 0.12 to 698.4) after primary definitive treatment with prostatectomy (65%), radiotherapy (35%) or both (19%). The 18F-DCFPyL positive lesions compatible with prostate cancer were evaluated by two independent readers. Impact of 18F-DCFPyL PET/CT on patient management was recorded from clinical chart review. Results: 18F-DCFPyL PET/CT had an overall positivity rate of 83% (125 scans), which increased with higher prostate specific antigen (PSA) levels (ng/mL): 63% (PSA < 0.5), 75% (0.5≤PSA < 1), 91% (1≤PSA < 2), 95% (2≤PSA < 5) and 98% (PSA≥5), respectively. In the cohort who underwent prostatectomy, 18F-DCFPyL PET/CT had higher positivity rate in patients with shorter PSA doubling time (PSAdt) (94% in PSAdt 0-3 months vs. 53% in PSAdt > 12 months, P< 0.01). No difference of 18F-DCFPyL positivity rate was observed in post-radiation patients with different PSAdt, nor were there differences between patients with low grade (Gleason 6) or higher-grade prostate cancer (Gleason 7-10). 20 patients (13%) had lesions in the prostate bed only and 41 patients (27%) had oligometastatic disease (1-3 lesions), making them candidates for locally targeted therapy. We identified a total of 1455 18F-DCFPyL positive lesions, including 51 lesions in the prostate bed, 271 pelvic and 463 extra-pelvic lymph nodes, approximately 585 osseous lesions, including 5 patients with diffuse osseous metastases, and 85 lesions in other organs (most commonly in the lungs). 91 out of 150 patients (61%) had change in treatment after 18F-DCFPyL PET and, most noticeably, 48 of these patients (32% total) had lesions only localized on 18F-DCFPyL PET/CT despite negative conventional imaging. Conclusions: 18F-DCFPyL PET/CT holds great potential to be a “one-stop shop” diagnostic tool in the work-up of BCR prostate cancer, with high (61%) impact on the management of these patients. Clinical trial information: NCT03501940 .


Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1594
Author(s):  
Aloÿse Fourquet ◽  
Lucien Lahmi ◽  
Timofei Rusu ◽  
Yazid Belkacemi ◽  
Gilles Créhange ◽  
...  

Background: Detection rates of [68Ga]Ga-PSMA-11 PET/CT on the restaging of prostate cancer (PCa) patients presenting with biochemical recurrence (BCR) have been well documented, but its performance and impact on patient management have not been evaluated as extensively. Methods: Retrospective analysis of PCa patients presenting with BCR and referred for [68Ga]Ga-PSMA-11 PET/CT. Pathological foci were classified according to six anatomical sites and evaluated with a three-point scale according to the uptake intensity. The impact of [68Ga]Ga-PSMA-11 PET/CT was defined as any change in management that was triggered by [68Ga]Ga-PSMA-11 PET/CT. The existence of a PCa lesion was established according to a composite standard of truth based on all clinical data available collected during the follow-up period. Results: We included 294 patients. The detection rate was 69%. Per-patient sensitivity and specificity were both 70%. Patient disease management was changed in 68% of patients, and [68Ga]Ga-PSMA-11 PET/CT impacted this change in 86% of patients. The treatment carried out on patient was considered effective in 89% of patients when guided by [68Ga]Ga-PSMA-11 PET/CT versus 61% of patients when not guided by [68Ga]Ga-PSMA-11 PET/CT (p < 0.001). Conclusions: [68Ga]Ga-PSMA-11 PET/CT demonstrated high performance in locating PCa recurrence sites and impacted therapeutic management in nearly two out of three patients.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 15-15 ◽  
Author(s):  
Jeremie Calais ◽  
Francesco Ceci ◽  
Kathleen Nguyen ◽  
Jeannine Gartmann ◽  
Matthias Eiber ◽  
...  

15 Background: 18F-Fluciclovine PET/CT (FACBC) is standard-of-care in US for localization of prostate cancer (PCa) biochemical recurrence (BCR) after definitive therapy. 68Ga-PSMA-11 PET/CT (PSMA) detects PCa BCR even at low prostate-specific antigen (PSA) levels (<2.0 ng/mL). We conducted a single-center prospective head-to-head comparison of these 2 PET/CT imaging tracers for localizing PCa BCR after radical prostatectomy (RP) in patients with PSA < 2.0 ng/ml. Methods: Patients with PCa BCR after RP and PSA levels ranging from ≥0.2 to ≤2.0 ng/mL without any prior salvage therapy were eligible. All patients underwent FACBC and PSMA scans within ≤15 days. Images analysis was performed a) by on-site clinical reading and b) by 3 blinded international expert readers for each modality. Detection rates on per-patient and per-region based analysis served as primary study endpoints. Based on literature data we hypothesized a detection rate difference of 22% in favor of PSMA. A power analysis determined a sample size of 50 patients. Results: The 50 patients were enrolled from March to September 2018. Median PSA level was 0.50 ng/ml. Median time interval between the 2 scans was 6 days. We present here the preliminary results from the non-blinded clinical reads. Detection rate on a per-patient basis was 69% for PSMA and 34% for FACBC. Concordant findings were observed in 30/49 patients (61%): 16/49 (32%) with both positive scans and 14/49 (29%) with both negative scans. Discordant findings were observed in 19/49 patients (39%): 18/49 (37%) had a positive PSMA but a negative FACBC scan while 1/49 (2%) had a positive FACBC with a negative PSMA (local recurrence). Detection rates were consistently lower for FACBC than for PSMA for all regions: Prostate bed (12% vs 20%), pelvic nodes (14% vs 37%), extra-pelvic nodes (2% vs 8%), skeleton (2% vs 8%) and visceral organs (2% vs 6%). Conclusions: This preliminary analysis from the non-blinded on-site clinical reads demonstrates prospectively that PSMA detection rates is more than double the FACBC detection rate in patients with PCa BCR after RP and with PSA ≤2.0 ng/ml. Clinical trial information: NCT03515577.


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