Prospective head-to-head comparative phase 3 study between 18F-fluciclovine and 68Ga-PSMA-11 PET/CT in patients with early biochemical recurrence of prostate cancer.

5014 Background: This is a prospective single-center, single-arm, head-to-head phase 3 study of paired 18F-fluciclovine (FACBC) and 68Ga-PSMA-11 (PSMA) PET/CT scans for localizing early biochemical recurrence (BCR) of prostate cancer (PCa) after radical prostatectomy (RP) (NCT02940262). Methods: Fifty consecutive patients with BCR and prostate specific antigen (PSA) levels ranging from ≥0.2 to ≤2.0 ng/mL without any prior salvage therapy were included. All patients underwent FACBC and PSMA PET/CT scans within ≤15 days. PET/CT scans were each interpreted by 3 independent blinded expert readers not involved in study design and data acquisition. Region consensus interpretation (T,N,M1a,M1b,M1c) was generated based on majority rule in cases of reader disagreement (2 vs 1). PET/CT scans were considered as positive if any region was rated as positive. Detection rates per-patient and per-region served as primary study endpoint. Results: Median time interval between the 2 scans was 6 days (range 1-15). Median PSA level at the time of imaging was 0.50 ng/ml (mean 0.63; range 0.2-2.0 ng/ml). The detection rates were significantly lower with FACBC than with PSMA PET/CT per-patient (26% vs 56%; p = 0.003) and per-region for pelvic nodes (N) (8% vs 30%; p = 0.003) or any extra-pelvic lesions (M) (0% vs 16%; p = 0.008). Reader agreement for PSMA PET/CT image interpretations was significantly higher than for FACBC PET/CT (0.67 vs 0.20; p = 0.015). Conclusions: In patients with BCR and low serum PSA levels after RP, PSMA PET/CT demonstrates higher detection rates and superior reader agreement when compared with FACBC PET/CT. Therefore, PSMA PET/CT should be the imaging modality of choice in patients with early BCR. Clinical trial information: NCT03515577.

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Prospective head-to-head comparison of 18F-fluciclovine and 68Ga-PSMA-11 PET/CT for localization of prostate cancer biochemical recurrence after primary prostatectomy.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.15 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. 15-15 ◽

Cited By ~ 5

Author(s):

Jeremie Calais ◽

Francesco Ceci ◽

Kathleen Nguyen ◽

Jeannine Gartmann ◽

Matthias Eiber ◽

...

Keyword(s):

Prostate Cancer ◽

Biochemical Recurrence ◽

Detection Rate ◽

Specific Antigen ◽

Standard Of Care ◽

Primary Study ◽

Time Interval ◽

Detection Rates ◽

Pet Ct ◽

Definitive Therapy

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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The Diagnostic Role of 18F-Choline, 18F-Fluciclovine and 18F-PSMA PET/CT in the Detection of Prostate Cancer With Biochemical Recurrence: A Meta-Analysis

Frontiers in Oncology ◽

10.3389/fonc.2021.684629 ◽

2021 ◽

Vol 11 ◽

Author(s):

Rang Wang ◽

Guohua Shen ◽

Mingxing Huang ◽

Rong Tian

Keyword(s):

Prostate Cancer ◽

Diagnostic Accuracy ◽

Biochemical Recurrence ◽

Meta Analysis ◽

Detection Rates ◽

Psma Pet ◽

Pet Ct ◽

Diagnostic Role ◽

Sensitivity Specificity

BackgroundDiagnosing the biochemical recurrence (BCR) of prostate cancer (PCa) is a clinical challenge, and early detection of BCR can help patients receive optimal treatment. We conducted a meta-analysis to define the diagnostic accuracy of PET/CT using 18F-labeled choline, fluciclovine, and prostate-specific membrane antigen (PSMA) in patients with BCR.MethodsMultiple databases were searched until March 30, 2021. We included studies investigating the diagnostic accuracy of 18F-choline, 18F-fluciclovine, and 18F-PSMA PET/CT in patients with BCR. The pooled sensitivity, specificity, and detection rate of 18F-labeled tracers were calculated with a random-effects model.ResultsA total of 46 studies met the included criteria; 17, 16, and 13 studies focused on 18F-choline, fluciclovine, and PSMA, respectively. The pooled sensitivities of 18F-choline and 18F-fluciclovine were 0.93 (95% CI, 0.85–0.98) and 0.80 (95% CI, 0.65–0.897), and the specificities were 0.91 (95% CI, 0.73–0.97) and 0.66 (95% CI, 0.50–0.79), respectively. The pooled detection rates of 18F-labeled choline, fluciclovine and PSMA were 66, 74, and 83%, respectively. Moreover, the detection rates of 18F-labeled choline, fluciclovine, and PSMA were 35, 23, and 58% for a PSA level less than 0.5 ng/ml; 41, 46, and 75% for a PSA level of 0.5–0.99 ng/ml; 62, 57, and 86% for a PSA level of 1.0–1.99 ng/ml; 80, 92, and 94% for a PSA level more than 2.0 ng/ml.ConclusionThese three 18F-labeled tracers are promising for detecting BCR in prostate cancer patients, with 18F-choline showing superior diagnostic accuracy. In addition, the much higher detection rates of 18F-PSMA showed its superiority over other tracers, particularly in low PSA levels.Systematic Review RegistrationPROSPERO, identifier CRD42020212531.

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Detection rates of recurrent prostate cancer: 68Gallium (Ga)-labelled prostate-specific membrane antigen versus choline PET/CT scans. A systematic review

Therapeutic Advances in Urology ◽

10.1177/1756287218815793 ◽

2019 ◽

Vol 11 ◽

pp. 175628721881579 ◽

Cited By ~ 6

Author(s):

Masood Moghul ◽

Bhaskar Somani ◽

Tim Lane ◽

Nikhil Vasdev ◽

Brian Chaplin ◽

...

Keyword(s):

Prostate Cancer ◽

Systematic Review ◽

Ct Scans ◽

Prostate Specific Membrane Antigen ◽

Recurrent Prostate Cancer ◽

Detection Rates ◽

Psma Pet ◽

Pet Ct ◽

Significant Difference ◽

Specific Membrane

Background: The aim of this work was to assess the use of prostate-specific membrane antigen (PSMA)-labelled radiotracers in detecting the recurrence of prostate cancer. PSMA is thought to have higher detection rates when utilized in positron emission tomography (PET)/computed tomography (CT) scans, particularly at lower prostate-specific antigen (PSA) levels, compared with choline-based scans. Methods: A systematic review was conducted comparing choline and PSMA PET/CT scans in patients with recurrent prostate cancer following an initial curative attempt. The primary outcomes were overall detection rates, detection rates at low PSA thresholds, difference in detection rates and exclusive detection rates on a per-person analysis. Secondary outcome measures were total number of lesions, exclusive detection by each scan on a per-lesion basis and adverse side effects. Results: Overall detection rates were 79.8% for PSMA and 66.7% for choline. There was a statistically significant difference in detection rates favouring PSMA [OR (M–H, random, 95% confidence interval (CI)) 2.27 (1.06, 4.85), p = 0.04]. Direct comparison was limited to PSA < 2 ng/ml in two studies, with no statistically significant difference in detection rates between the scans [OR (M–H, random, 95% CI) 2.37 (0.61, 9.17) p = 0.21]. The difference in detection on the per-patient analysis was significantly higher in the PSMA scans ( p < 0.00001). All three studies reported higher lymph node, bone metastasis and locoregional recurrence rates in PSMA. Conclusions: PSMA PET/CT has a better performance compared with choline PET/CT in detecting recurrent disease both on per-patient and per-lesion analysis and should be the imaging modality of choice while deciding on salvage and nonsystematic metastasis-directed therapy strategies.

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PSMA PET/CT vs. CT alone in newly diagnosed biochemical recurrence of prostate cancer after radical prostatectomy: Comparison of detection rates and therapeutic implications

European Journal of Radiology ◽

10.1016/j.ejrad.2021.109556 ◽

2021 ◽

Vol 136 ◽

pp. 109556

Author(s):

J. Morawitz ◽

J. Kirchner ◽

J. Lakes ◽

N.M. Bruckmann ◽

E. Mamlins ◽

...

Keyword(s):

Prostate Cancer ◽

Radical Prostatectomy ◽

Biochemical Recurrence ◽

Newly Diagnosed ◽

Detection Rates ◽

Therapeutic Implications ◽

Psma Pet ◽

Pet Ct

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Assessment of volumetric parameters derived from 68Ga-PSMA PET/CT in prostate cancer patients with biochemical recurrence

Nuclear Medicine Communications ◽

10.1097/mnm.0000000000001459 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Berna Okudan ◽

Nazim Coşkun ◽

Bedri Seven ◽

Merve Ağcioğlu Atalay ◽

Aslihan Yildirim ◽

...

Keyword(s):

Prostate Cancer ◽

Cancer Patients ◽

Biochemical Recurrence ◽

Psma Pet ◽

Pet Ct

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The value of intravenous contrast medium in PSMA PET/CT imaging in patients with biochemical recurrence of prostate cancer

Nuclear Medicine Communications ◽

10.1097/mnm.0000000000001453 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Alain Winiger ◽

Maria del Sol Pérez Lago ◽

Dirk Lehnick ◽

Justus E. Roos ◽

Klaus Strobel

Keyword(s):

Prostate Cancer ◽

Contrast Medium ◽

Biochemical Recurrence ◽

Ct Imaging ◽

Intravenous Contrast ◽

Intravenous Contrast Medium ◽

Psma Pet ◽

Pet Ct

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Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

Cancers ◽

10.3390/cancers13194982 ◽

2021 ◽

Vol 13 (19) ◽

pp. 4982

Author(s):

Carlos Artigas ◽

Romain Diamand ◽

Qaid Ahmed Shagera ◽

Nicolas Plouznikoff ◽

Fabrice Fokoue ◽

...

Keyword(s):

Prostate Cancer ◽

Radical Prostatectomy ◽

Cancer Patients ◽

Predictive Factors ◽

Clinical Management ◽

Biochemical Recurrence ◽

Oligometastatic Disease ◽

Psma Pet ◽

Pet Ct ◽

Hormone Sensitive

Metastasis-directed therapy (MDT) in oligometastatic prostate cancer has the potential of delaying the start of androgen deprivation therapy (ADT) and disease progression. We aimed to analyze the efficacy of PSMA-PET/CT in detecting oligometastatic disease (OMD), to look for predictive factors of OMD, and to evaluate the impact of PSMA-PET/CT findings on clinical management. We retrospectively analyzed a homogeneous population of 196 hormone-sensitive prostate cancer patients (HSPC), considered potential candidates for MDT, with a PSMA-PET/CT performed at biochemical recurrence (BCR) after radical prostatectomy (RP). Multivariable logistic regression analysis was performed based on several clinico-pathological factors. Changes in clinical management before and after PSMA-PET/CT were analyzed. The OMD detection rate was 44% for a total positivity rate of 60%. PSMA-PET/CT positivity was independently related to PSA (OR (95%CI), p) (1.7 (1.3–2.3), p < 0.0001) and PSAdt (0.4 (0.2–0.8), p = 0.013), and OMD detection was independently related to PSA (1.6 (1.2–2.2), p = 0.001) and no previous salvage therapy (0.3 (0.1–0.9), p = 0.038). A treatment change was observed in 58% of patients, mostly to perform MDT after OMD detection (60% of changes). This study showed that PSMA-PET/CT is an excellent imaging technique to detect OMD early in HSPC patients with BCR after RP, changing therapeutic management mostly into MDT.

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The Impact of 18F-DCFPyL PSMA PET-CT in the Management of Prostate Cancer Biochemical Recurrence

Open Journal of Urology ◽

10.4236/oju.2021.1111038 ◽

2021 ◽

Vol 11 (11) ◽

pp. 393-403

Author(s):

Raquel García ◽

Virginia Morillo ◽

Pablo Sopena ◽

Miguel R. Soler ◽

María Rodríguez ◽

...

Keyword(s):

Prostate Cancer ◽

Biochemical Recurrence ◽

Psma Pet ◽

Pet Ct ◽

The Impact

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[68Ga]Ga-PSMA-11 PET-CT: Local preliminary experience in prostate cancer biochemical recurrence patients

Archivio Italiano di Urologia e Andrologia ◽

10.4081/aiua.2021.1.21 ◽

2021 ◽

Vol 93 (1) ◽

pp. 21-25

Author(s):

João Carvalho ◽

Pedro Nunes ◽

Edgar Tavares Da Silva ◽

Rodolfo Silva ◽

João Lima ◽

...

Keyword(s):

Prostate Cancer ◽

Complete Remission ◽

Biochemical Recurrence ◽

Detection Rate ◽

Salvage Treatment ◽

Clinical Approach ◽

Curative Intent ◽

Psma Pet ◽

Pet Ct ◽

Pelvic Relapse

Objectives: Clinical approach of prostate cancer (PCa) biochemical recurrence (BCR) is an ever-changing topic. Prostate-specific membrane antigen positron emission tomography ([68Ga]Ga-PSMA-11 PET-CTPSMA PET-CT) has shown good potential in this field. The aim is to evaluate PSMA PET-CT detection rate in PCa BCR and assess its impact on clinical outcome. Material and methods: Out of 319 patients with PCa who underwent PSMA PET-CT between October 2015 and June 2019, 70 had developed BCR after treatment with curative intent. Two groups were created: one with BCR after surgery (RP group) (N: 48; 68.6%) and other with BCR after radiotherapy (RT group) (N: 22; 31.4%). Clinical, analytical, pathological and PSMA PET-CT results were evaluated. Results: Initial age was different between groups (p = 0.008). RP patients were mainly at intermediate risk (85.1% vs 42.9%, p = 0.001) while RT patients were at low risk of recurrence (8.5% vs 47.6%, p = 0.001). In RP and RT groups, PSMA PETCT detected, respectively, pelvic relapse in 31.3% and 63.6%, and extrapelvic relapse in 18.8% and 31.8%. Salvage treatment was performed in 61.9% (n = 26) of RP patients and in 15% (n = 3) of RT patients, p < 0.001. Of RP patients submitted to salvage treatment, 59.1% achieved complete remission. Concerning these patients, local radiotherapy led to complete remission in 68.4% (n = 13). Of RT patients submitted to salvage treatment, two had complete remission and one had partial remission.Concerning detection rate, PSMA PET-CT was positive for pelvic relapse when pre-PET PSA ≥ 0.8 ng/mL (RP) or ≥ 2.3 ng/mL (RT) and for extrapelvic relapse when PSA ≥ 0.4 ng/mL (RP) or ≥ 3.5 ng/mL (RT), p > 0.05. Conclusions: Biochemical persistence rate after salvage therapy was similar (30-40%). The cut-off PSA values for pelvic relapse detected on PSMA PET-CT were ≥ 0.8 ng/mL (RP) and ≥ 2.3 ng/mL (RT).

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