A randomized trial comparing fluorocholine-PET/CT with conventional imaging in prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 2-2
Author(s):  
Scott Williams ◽  
Jean-Mathieu Beauregard ◽  
Peter Roselt ◽  
Kate Moody ◽  
Richard Fisher ◽  
...  

2 Background: We conducted a randomised trial comparing 18Flourocholine-PET/CT (FCH) to Computed Tomography (abdomen and pelvis) plus 99mTc-Whole Body Bone Scan (Conventional Imaging [CIm]) to determine imaging performance in prostate cancer (PC). Methods: This prospective two-arm 1:1 randomised trial enrolled men with newly diagnosed or biochemically recurrent PC to first-line imaging (FLI) with either CIm or FCH. Participants without evidence of metastases proceeded to second-line imaging (SLI) using the alternative imaging strategy. The primary aim was to determine whether FCH was more effective as a FLI approach in changing management. Secondary endpoints included incremental utility of SLI and negative predictive value (NPV) based on progression-free survival (PFS). Australian New Zealand Clinical Trials Registry ACTRN12608000641392. Results: 108 men were enrolled; 44% were for staging of newly-diagnosed PC and median follow-up 43 months. Imaging impacted clinical management in 32.4% of men (95% CI=23.7-42.1%), mostly with FLI (n=30). High-impact management changes occurred in 27.8% (95% CI=16.5-41.6%) of FCH cases compared with 11.1% (95% CI=4.2-22.6%) in the CIm arm (p=0.032). The final management plan was derived using FCH in 98.1% (95% CI = 90.1-100%) of cases and 92.6% (95%CI = 82.1-97.9%) of CIm cases (p=0.242). FLI with FCH showed unequivocally N1 or M1 disease in 22.2% (95% CI = 12-35.6%), and 16.7% (95% CI = 7.9-29.3%; p= 0.531) of CIm cases. The overall NPV for stage TxN0M0 (from all imaging) was 26.3% (95% CI: 13.9 - 41.2%), with no significant difference between arms (p=0.9). For N1M0 cases, the NPV was 14.3% (95% CI: 7.1 - 35.7%). The identification of N1M0 by FCH resulted in a longer time to identification of progressive disease, with a median PFS of 32 months (95% CI=2-68months) compared with 3 months (95% CI=1-16 months) in the CIm N1M0 cohort (p=0.05). Conclusions: FCH-PET/CT identifies more high-clinical-impact lesions than CIm as first-line imaging. All imaging modalities were poor at predicting subsequent progressive disease. Isolated node-positive disease seen with FCH is associated with a longer time to - but similarly high rates of - recurrence, suggesting a lead-time bias. Clinical trial information: ACTRN12608000641392.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
V. Mohan ◽  
N. M. Bruin ◽  
J. B. van de Kamer ◽  
J.-J. Sonke ◽  
W. V. Vogel

Abstract Rationale PSMA-directed therapy for metastatic prostate cancer is gaining adoption as a treatment option. However, accumulation of 177Lu/225Ac-PSMA in the salivary glands remains a problem, with risk of dose-limiting xerostomia and potentially severe effect on the quality of life. Gustatory stimulation is an approach that has commonly been used in radioactive iodine therapy to reduce accumulation in the salivary glands. However, based on theoretical differences in biodistribution, it was hypothesized that this could potentially lead to adverse increased toxicity for PSMA-ligand therapy. The primary objective of this work was to determine if gustatory stimulation by eating an assortment of sweet/fatty/acidic foods during the biodistribution phase of [18F]DCFPyl could result in a clinically relevant (> 30%) change in the uptake of the tracer in the salivary glands. Methods 10 patients who already received a whole-body [18F]DCFPyl PET/CT scan for evaluation of prostate cancer, underwent a repeat (intervention) PET/CT scan within a month of the first (control) scan. During the intervention scan, patients chose from an assortment of sweet/fatty/acidic foods, which they then chewed and swallowed for a period of time starting 1 min before tracer administration to 10 min thereafter. Data from both scans were analyzed by placing VOIs on the major salivary glands and segmenting them using relative thresholds. Results A slight increase in PSMA uptake in the parotid glands was observed on the intervention scan when compared to the baseline scan (+ 7.1% SULmean and + 9.2% SULmax, p < 0.05). No significant difference in PSMA uptake in the submandibular glands was seen. Conclusions Eating only slightly increases uptake of [18F]DCFPyl in the parotid glands. We nonetheless recommend refraining from gustatory stimulation during the administration and early biodistribution phase of radionuclide therapy with PSMA-ligands to reduce the risk of avoidable additional toxicity.


2020 ◽  
Vol 45 (12) ◽  
pp. 4202-4213
Author(s):  
Qiong Zou ◽  
Ju Jiao ◽  
Min-hong Zou ◽  
Ming-zhao Li ◽  
Ting Yang ◽  
...  

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
V. Mohan ◽  
N. M. Bruin ◽  
M. E. T. Tesselaar ◽  
J. P. de Boer ◽  
E. Vegt ◽  
...  

Abstract Rationale Salivary glands are highly perfused and express the prostate-specific membrane antigen (PSMA) receptor as well as the sodium—iodide symporter. As a consequence, treatment with 177Lu/225Ac-PSMA for prostate cancer or 131I for thyroid cancer leads to a high radiation dose in the salivary glands, and patients can be confronted with persistent xerostomia and reduced quality of life. Salivation can be inhibited using an antimuscarinic pharmaceutical, such as glycopyrronium bromide (GPB), which may also reduce perfusion. The primary objective of this work was to determine if inhibition with GPB could provide a considerable (> 30%) reduction in the accumulation of administered 123I or 68Ga-PSMA-11 in salivary glands. Methods Ten patients who already received a whole-body 68Ga-PSMA-11 PET/CT scan for (re)staging of prostate cancer underwent a repeat PET/CT scan with tracer administration at 90 min after intravenous injection of 0.2 mg GPB. Four patients in follow-up after thyroid cancer, who had been treated with one round of ablative 131I therapy with curative intent and had no signs of recurrence, received 123I planar scintigraphy at 4 h after tracer administration without GPB and a repeated scan at least one week later, with tracer administration at 30 min after intramuscular injection of 0.4 mg GPB. Tracer uptake in the salivary glands was quantified on PET and scintigraphy, respectively, and values with and without GPB were compared. Results No significant difference in PSMA uptake in the salivary glands was seen without or with GPB (Mean SULmean parotid glands control 5.57, intervention 5.72, p = 0.50. Mean SULmean submandibular glands control 6.25, intervention 5.89, p = 0.12). Three out of 4 patients showed increased 123I uptake in the salivary glands after GPB (Mean counts per pixel control 8.60, intervention 11.46). Conclusion Muscarinic inhibition of salivation with GPB did not significantly reduce the uptake of PSMA-ligands or radioiodine in salivary glands, and can be dismissed as a potential strategy to reduce toxicity from radionuclide therapies.


2021 ◽  
Vol 60 (06) ◽  
pp. 417-424
Author(s):  
Lara Franziska Stolzenbach ◽  
Florian Löcherbach ◽  
Tobias Maurer ◽  
Christoph Berliner ◽  
Katharina Wargenau ◽  
...  

Abstract Aim Few small-scaled studies performed systematic analysis of the benefits of extending prostate specific membrane antigen positron-emission tomography/ computed tomography (68Ga-PSMA I&T PET/CT) to the lower extremities in prostate cancer (PCa) patients. We hypothesized that 68Ga-PSMA I&T PET/CT positive lesions are rare in lower extremities of prostate cancer (PCa) patients, the clinical implication is negligible and may therefore be omitted. Methods We retrospectively analyzed 1,068 PCa patients who received 68Ga-PSMA I&T PET/CT in a single institution (2016–2018). Of those, 285 (26.7%) were newly diagnosed, 529 (49.5%) had biochemical recurrence (BCR) and 254 (23.8%) were castration-resistant prostate cancer (CRPC) patients. Results Of 1,068 68Ga-PSMA I&T PET/CTs, positive lesions in the lower extremities were identified in 6.9% patients (n=74). Positive lesions in the lower extremities were most common in CRPC patients (19.7%; n=50), followed by newly diagnosed (3.2%; n=9) and BCR (2.8%; n=15) PCa patients. Only 3 patients presented with exclusive lesions in the lower extremities, respectively 0.8% (n=2) in CRPC and 0.4% (n=1) in newly diagnosed PCa. Both CRPC (94.1%, n=47) and BCR (80.0%, n=12) patients with PSMA-positive lesions predominantly received systemic therapy. Conclusion Identification of lower extremities lesions with PSMA PET/CT is uncommon and exclusive lesions are rare. PSMA PET/CT findings of the lower extremities did not change therapy management. Thus, scanning of the lower extremities can be omitted in standard protocols.


2020 ◽  
Author(s):  
Chunxia Qin ◽  
Yongkang Gai ◽  
Qingyao Liu ◽  
Weiwei Ruan ◽  
Fang Liu ◽  
...  

Abstract Purpose To analyze 68Ga-PSMA-617 PET/CT or PET/MR and delayed PET/MR images in patients diagnosed with or suspected of prostate cancer, and to explore the optimal use of PET/CT and PET/MR for initial diagnosis and staging in prostate diseases.Methods Images from conventional scan by 68Ga-PSMA whole-body PET/CT or PET/MR followed by delayed pelvic PET/MR were retrospectively analyzed. Prostatic 68Ga-PSMA uptake was measured as SUVmax1 (conventional scan 1 h post injection) and SUVmax2 (delayed scan 3 h post injection). Age, PSA levels, and SUVmax were compared between benign and malignant cases. The correlation of SUVmax1 and SUVmax 2 was analyzed. Diagnostic performance was evaluated by ROC analysis.Results We enrolled 56 patients with 41 malignant and 15 benign prostate lesions. Fifty-three patients had paired conventional and delayed scans. Age, PSA levels, and SUVmax were significantly different between benign and malignant cases. A good correlation was found between SUVmax1 and SUVmax2. There was significant difference between SUVmax1 and SUVmax2 in the malignant group (p = 0.001). SUVmax1 had superior diagnostic performance than SUVmax2, SUVmax difference and PSA levels, with a sensitivity of 85.4%, a specificity of 100% and an AUC of 0.956. A combination of SUVmax1 with nodal and/or distant metastases and MR PIRADS V2 score had a sensitivity and specificity of 100%. Delayed pelvic PET/MR imaging in 33 patients were found to be redundant because these patients had nodal and/or distant metastases which can be easily detected by PET/CT.Conclusion Combined 68Ga-PSMA whole-body PET/CT and pelvic PET/MR can accurately differentiate benign prostate diseases from prostate cancer and accurately stage prostate cancer. Whole-body PET/CT is sufficient for advanced prostate cancer, and more economic and time-saving than PET/MR. Pelvic PET/MR contributes to diagnosis and accurate staging in early prostate cancer. Imaging at about 1 hour after injection is sufficient in most patients.Trial registration: NCT03756077. Registered 27 November 2018 - Retrospectively registered, https://clinicaltrials.gov/show/NCT03756077


2021 ◽  
Vol 8 ◽  
Author(s):  
Chunxia Qin ◽  
Yongkang Gai ◽  
Qingyao Liu ◽  
Weiwei Ruan ◽  
Fang Liu ◽  
...  

Purpose: To analyze 68Ga-PSMA-617 PET/CT or PET/MR and delayed PET/MR images in patients diagnosed with or suspicion of prostate cancer, and to explore the optimal use of PET/CT and PET/MR for initial diagnosis and staging in prostate cancer.Methods: Images from conventional scan by 68Ga-PSMA whole-body PET/CT or PET/MR followed by delayed pelvic PET/MR were retrospectively analyzed. Prostatic 68Ga-PSMA uptake was measured as SUVmax1 (conventional scan 1 h post injection) and SUVmax2 (delayed scan 3 h post injection). Age, PSA levels, and SUVmax were compared between benign and malignant cases. The correlation of SUVmax1 and SUVmax2 was analyzed. Diagnostic performance was evaluated by ROC analysis.Results: Fifty-six patients with 41 prostate cancers and 15 benign prostate lesions were enrolled. Fifty-three patients had paired conventional and delayed scans. Age, tPSA, fPSA levels, and SUVmax were significantly different between benign and malignant cases. A good correlation was found between SUVmax1 and SUVmax2. There was significant difference between SUVmax1 and SUVmax2 in the malignant group (p = 0.001). SUVmax1 had superior diagnostic performance than SUVmax2, SUVmax difference and PSA levels, with a sensitivity of 85.4%, a specificity of 100% and an AUC of 0.956. A combination of SUVmax1 with nodal and/or distant metastases and MR PI-RADS V2 score had a sensitivity and specificity of 100%. Delayed pelvic PET/MR imaging in 33 patients were found to be redundant because these patients had nodal and/or distant metastases which can be easily detected by PET/CT. PET/MR provided incremental value in 8 patients at early-stage prostate cancer based on precise anatomical localization and changes in lesion signal provided by MR.Conclusion: Combined 68Ga-PSMA whole-body PET/CT and pelvic PET/MR can accurately differentiate benign prostate diseases from prostate cancer and accurately stage prostate cancer. Whole-body PET/CT is sufficient for advanced prostate cancer. Pelvic PET/MR contributes to diagnosis and accurate staging in early prostate cancer. Imaging at about 1 h after injection is sufficient in most patients.ClinicalTrials.gov: NCT03756077. Registered 27 November 2018—Retrospectively registered, https://clinicaltrials.gov/show/NCT03756077.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 36-36
Author(s):  
Ashanda Rosetta Patrice Esdaille ◽  
Edward Lawrence ◽  
Christos Kyriakopoulos ◽  
Brian Johnson ◽  
Alejandro Roldán-Alzate ◽  
...  

36 Background: Interest has arisen in the use of prostate specific membrane antigen (PSMA) PET/CT imaging to detect prostate cancer at metastatic sites using different tracers. Here, we examined the ability of 18F-DCFPyL (DCFPyL) PSMA-based PET imaging to detect nodal disease in comparison to conventional imaging in a cohort of men with locally advanced or oligometastatic prostate cancer (PC). Methods: UW17009 is an IRB-approved open-label, single-arm trial that enrolled 26 patients with newly diagnosed advanced PC. Patients received androgen deprivation therapy and docetaxel for 3 months followed by radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Exploratory interventions include PSMA PET/CT and MRI imaging as a method for determining treatment response and heterogeneity in primary PC and metastatic lesions performed before and after chemohormonal therapy. Prior to randomization, patients received DCFPyL PET/CT and PET/MR imaging as well as CTs and Bone Scans. A mean dose of 7.86 mCi DCFPyL was administered. Whole-body PET/CT images were acquired starting at approximately 60 minutes after radiotracer injection followed by dedicated pelvic PET/MR and whole-body PET/MR. PET imaging findings were compared to conventional dedicated CT imaging and were correlated to the results of final pathologic examination of each pelvic nodal dissection. Results: 26 patients underwent conventional and exploratory imaging with subsequent neoadjuvant treatment, RP and PLND. The mean diagnostic PSA was 32.1 ng/dl and 88.5% had Gleason 9 PCa. Using conventional imaging, pelvic nodal disease was identified in 6/26 patients. Pelvic lymph node uptake was identified in 12/26 patients using DCFPyL-based PSMA PET. Initial correlation of the pathologic specimens with pretreatment PSMA PET imaging revealed pelvic nodal metastatic PC in 10/12(83%) patients. On a per-lymph node packet basis (6 per patient), there were 156 evaluable regions, including 65 from patients with positive nodes. PSMA detected 14 packets that were positive for PC and 102 packets that were negative on imaging and final pathology. PC was missed in 5 packets. The mean tumor size in the missed nodes was 2.3 mm(range 1-4 mm). Calculated sensitivity was 73.7%(95% CI [48.8, 90.8]), 85.7 % specificity(95% CI[78.1, 91.4]), and 95.3 % negative predictive value(95% CI[90.5, 97.7]). Conclusions: In comparison to conventional imaging, in this cohort, DCFPyL PSMA-based PET imaging identified nodal positive disease at twice the rate and when evaluating on a per-packet basis, there was high negative predictive value. Ongoing analysis of post-chemohormonal therapy PET imaging may provide more information regarding tumor response in this cohort.


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Arnoldo Piccardo ◽  
Francesco Paparo ◽  
Riccardo Picazzo ◽  
Mehrdad Naseri ◽  
Paolo Ricci ◽  
...  

Purpose. We compared the accuracy of18F-Choline-PET/MRI with that of multiparametric MRI (mMRI),18F-Choline-PET/CT,18F-Fluoride-PET/CT, and contrast-enhanced CT (CeCT) in detecting relapse in patients with suspected relapse of prostate cancer (PC) after external beam radiotherapy (EBRT). We assessed the association between standard uptake value (SUV) and apparent diffusion coefficient (ADC).Methods. We evaluated 21 patients with biochemical relapse after EBRT. Patients underwent18F-Choline-PET/contrast-enhanced (Ce)CT,18F-Fluoride-PET/CT, and mMRI. Imaging coregistration of PET and mMRI was performed.Results.18F-Choline-PET/MRI was positive in 18/21 patients, with a detection rate (DR) of 86%. DRs of18F-Choline-PET/CT, CeCT, and mMRI were 76%, 43%, and 81%, respectively. In terms of DR the only significant difference was between18F-Choline-PET/MRI and CeCT. On lesion-based analysis, the accuracy of18F-Choline-PET/MRI,18F-Choline-PET/CT, CeCT, and mMRI was 99%, 95%, 70%, and 85%, respectively. Accuracy, sensitivity, and NPV of18F-Choline-PET/MRI were significantly higher than those of both mMRI and CeCT. On whole-body assessment of bone metastases, the sensitivity of18F-Choline-PET/CT and18F-Fluoride-PET/CT was significantly higher than that of CeCT. Regarding local and lymph node relapse, we found a significant inverse correlation between ADC and SUV-max.Conclusion.18F-Choline-PET/MRI is a promising technique in detecting PC relapse.


Author(s):  
Matteo Apicella ◽  
Stefano Bola ◽  
Duccio Volterrani ◽  
Laura Mazoni ◽  
Gianluca Frustaci ◽  
...  

2018 ◽  
Vol 64 (6) ◽  
pp. 799-804
Author(s):  
Darya Ryzhkova ◽  
M. Poyda

Purpose: To study the diagnostic value of PET-CT with 68Ga-PSMA-11 in the diagnosis of a primary prostate cancer, preoperative staging, and the detection of recurrence of prostate cancer (PCa). Methods: 28 patients aged 64.7 ± 8.74 years were included. 10 patients primary prostate cancer, and 18 patients with biochemical recurrence of the disease after radical treatment were examined. All patients underwent PET-CT with 68Ga-PSMA-11 according the whole body protocol. Interpretation of images was performed visually and quantitatively by calculation of SUL max. Results: High focal or diffuse 68Ga-PSMA-11 uptake was found in prostate parenchyma in patients with primary prostate cancer. Additionally metastases in regional lymph nodes were diagnosed in 4 patients and bone metastases were found in one patient. The correlation between 68Ga-PSMA-11 uptake level and Gleason index in the primary tumor (R Spearmen = 0.25, p = 0.57) was not observed. PET-positive results were obtained in 14 patients and PET-negative results in 4 patients with biochemical recurrence of PCa. The relationship between the frequency of PET-positive results and Gleason index was not revealed (R Spearmen = 0.2, p = 0.39). We found a weak but significant correlation between the frequency of PET-positive results and the prostate tumor stage according to the T category (R Spearmen = 0.49, p = 0.049). In patients with low values of PSA (less than 1.0 ng/ml) in 4 out of 9 cases, PET-negative results were obtained. In patients with PSA level more than 1.0 ng/ml PET-positive results were obtained in all cases. Conclusions: PET/CT with 68Ga-PSMA-11 allows to diagnose the primary prostate cancer, to establish the stage of the disease in categories N and M, and also to determine the localization and dissemination of the tumor in patients with biochemical recurrence of prostate cancer. The relationship between 68Ga-PSMA-11 uptake in primary tumor and Gleason index was not found. The probability of obtaining PET-positive results in cases of biochemical recurrence is affected by a PSA level above 1 ng/ml and a high stage of the disease according to the T category (T3-T4).


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