scholarly journals Optimized Application of 68Ga-Prostate-Specific Membrane Antigen-617 Whole-Body PET/CT and Pelvic PET/MR in Prostate Cancer Initial Diagnosis and Staging

2021 ◽  
Vol 8 ◽  
Author(s):  
Chunxia Qin ◽  
Yongkang Gai ◽  
Qingyao Liu ◽  
Weiwei Ruan ◽  
Fang Liu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Diagnostic Performance ◽  
Distant Metastases ◽  
Initial Diagnosis ◽  
Whole Body ◽  
Post Injection ◽  
Pet Ct ◽  
Significant Difference ◽  
Prostate Diseases ◽  
Benign Prostate

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.

scholarly journals Optimized application of 68Ga-prostate-specific membrane antigen-617 whole-body PET/CT and pelvic PET/MR in prostate cancer initial diagnosis and staging

2020 ◽  
Author(s):  
Chunxia Qin ◽  
Yongkang Gai ◽  
Qingyao Liu ◽  
Weiwei Ruan ◽  
Fang Liu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Diagnostic Performance ◽  
Distant Metastases ◽  
Initial Diagnosis ◽  
Whole Body ◽  
Post Injection ◽  
Pet Ct ◽  
Significant Difference ◽  
Prostate Diseases ◽  
Benign Prostate

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

Impact of the 18F- PET/CT scan in the management of patients with high-risk or intermediate-risk prostate cancer at initial diagnosis or at recurrence.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 87-87
Author(s):  
Gilles Pasticier ◽  
Marine Chicart ◽  
Marine Gross-Goupil ◽  
Laurence Donon ◽  
Gregoire Robert ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Ct Scan ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Initial Diagnosis ◽  
Whole Body ◽  
Pet Ct ◽  
The Impact ◽  
Pet Ct Scan ◽  
Initial Staging

87 Background: It is reported that a Fcholine Positron Emission Tomography (PET/CT) scan can change the management of the patients with prostate cancer up to 20% of the cases. The aim of this study was to evaluate the impact of 18FCholine PET/CT when its indication was taken by a multi-disciplinary staff in case of initial diagnosis or in case of recurrence. Methods: This retrospective study involved 84 patients between May 2013 and July 2014. After a selective approach 86 18F-PET/CT were performed consecutively: 37 (43%) for the initial staging and 49 (57%) in biochemical failure. The acquisition protocol included a pelvic dynamic scan after injection of 4 MBq/kg of 18FCholine followed by a whole-body scan. Mean age, PSA level and Gleason score were respectively in relapse and initial staging: 71 years (59-82), 4.9 (0.12-32.8), 7 (6-9) and 63 years (48-76), 16 (2.42-55) and 8 (6-10). Results: In initial diagnosis, prostate cancer was identified in all the patients on PET/CT. Local disease was seen in 23/37 scans (62.2%); loco-regional node involvement in 8 (21.6%) and metastatic disease in 6 (16.2%). PET/CT confirmed the therapeutic decision in 48.6% of cases and led to a therapeutic modification in 43.2% of cases,avoiding radical prostatectomy and lymphadenectomy in 25% of cases or modifying the extend of radiotherapy (25%) . In biochemical recurrence, PET/CT showed relapse in the prostatic area in 14 patients (28.6%); abnormal pelvic lymph nodes in 10 cases (20.4%) and distant metastases in 18 patients (36.7%). It failed to identify the cause of relapse in 7 cases (14.3%). PET/CT confirmed the therapeutic approach in 24.5% and led to a therapeutic change in 61.2% of cases The diagnostic performance of the FCholine PET/CT scan on nodes, according to the pathological results were: sensitivity 80 %, specificity 84.6%, positive predictive value 66.7% and negative predictive value 91.7 % Conclusions: A rigorous selection of the patients before the realization of a FCholine PET/CT scan in the management of a prostate cancer can increase the diagnostic performance and provide a better impact. In this study the treatment modification affected 54.8% of the patients.

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 ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Progressive Disease ◽  
Randomised Trial ◽  
Whole Body ◽  
Conventional Imaging ◽  
Newly Diagnosed ◽  
First Line ◽  
Pet Ct ◽  
Significant Difference ◽  
Line Imaging

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.

scholarly journals The effect of eating on the uptake of PSMA ligands in the salivary glands

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
V. Mohan ◽  
N. M. Bruin ◽  
J. B. van de Kamer ◽  
J.-J. Sonke ◽  
W. V. Vogel
Keyword(s):  
Prostate Cancer ◽  
Ct Scan ◽  
Salivary Glands ◽  
Primary Objective ◽  
Whole Body ◽  
Parotid Glands ◽  
Pet Ct ◽  
Significant Difference ◽  
Gustatory Stimulation ◽  
Pet Ct Scan

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.

11C-choline PET/CT in selection of patients for salvage cryoablation in recurrent prostate cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 188-188
Author(s):  
Anthonius J. Breeuwsma ◽  
Maxim Rybalov ◽  
Anna Maria Leliveld ◽  
Rudi A. Dierckx ◽  
Jan Pruim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Distant Metastases ◽  
Whole Body ◽  
Choline Pet ◽  
Prostate Biopsies ◽  
Pet Ct ◽  
Ct System ◽  
Selection Of Patients ◽  
Selection Of

188 Background: 11C-choline PET/CT has proven to be a sensitive technique for re-staging after radiation therapy (RT). The aim of this study was to analyze the clinical impact of 11C-choline-PET/CT in the selection of patients with biochemical recurrence (BCR) after RT for salvage cryoablation of the prostate. Methods: This prospective study was conducted between November 2006 and February 2012 on patients considered as candidates for salvage cryoablation. 74 patients, mean age 69.2 years, median – 70.3 years (range 49-79), who were being followed up after RT for histological proven prostate cancer (according to ASTRO-Phoenix) were included. Until 2009 we used PET/CT fusion, but from 2009 all patients were examined with an integrated PET/CT system. After receiving 400 MBq 11C-choline intravenously, a whole body scan was made. As reference we used biopsy-proven histology from site of suspicion, confirmative imaging modalities (bonescan, CT) or clinical follow-up. PSA doubling time and velocity was calculated. Results: According to the PET/CT results, 40 (54%) patients had a local recurrence, 20 (27%) had regional/distant metastases and 14 (19%) had a negative scan. The positive PET findings were proved by histology from prostate biopsies and/or pelvic lymph node dissections in 63% of cases. Considering PET/CT results: 50/74 (68%) patients received cryoablation, for 24/74 (32%) treatment was changed (active surveillance or androgen deprivation therapy). Conclusions: 11C-choline-PET/CT could be useful for the selection of patients with BCR after RT for salvage cryoablation of the prostate. 11C-choline-PET/CT was decisive and led to therapy change in 32% of cases. [Table: see text]

scholarly journals Muscarinic inhibition of salivary glands with glycopyrronium bromide does not reduce the uptake of PSMA-ligands or radioiodine

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
V. Mohan ◽  
N. M. Bruin ◽  
M. E. T. Tesselaar ◽  
J. P. de Boer ◽  
E. Vegt ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Thyroid Cancer ◽  
Ct Scan ◽  
Salivary Glands ◽  
Whole Body ◽  
Parotid Glands ◽  
Glycopyrronium Bromide ◽  
Pet Ct ◽  
Significant Difference ◽  
Pet Ct Scan

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.

scholarly journals 68Ga-DOTA-DiPSMA PET/CT Imaging: Biodistribution, Dosimetry and First Comparison with 68Ga-PSMA-11 in Prostate Cancer

2021 ◽  
Author(s):  
Jiaying Zhang ◽  
Zefang Lin ◽  
Xiaojun Zhang ◽  
Rong Lin ◽  
Mengchao Cui ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Healthy Volunteers ◽  
Bladder Wall ◽  
Prospective Trial ◽  
Whole Body ◽  
Post Injection ◽  
Diagnostic Efficacy ◽  
Organ Doses ◽  
Pet Ct ◽  
Effective Doses

Abstract PurposeThis prospective trial aimed to evaluate the safety, dosimetry, biodistribution, and diagnostic efficacy of a novel theranostic probe 68Ga-DOTA-DiPSMA. Also, we have performed the first comparison with 68Ga-PSMA-11 in prostate cancer (PCa) patients.MethodsFive healthy volunteers and ten PCa patients with a previous clinical 68Ga-PSMA-11 PET/CT were injected with an intravenous bolus of 68Ga-DOTA-DiPSMA with a dose of 1.85MBq/kg. Healthy volunteers received serial whole-body PET scans from the time of injection up to 60 min post-injection, with a second PET/CT scanning at 120 min post-injection. In PCa patients, low-dose CT scan, whole-body PET was performed with 2 min per bed position in 40 min post-injection. In addition, 68Ga-PSMA-11 scanning was performed on PCa patients within 10 days under the same acquisition procedure. Absorbed organ doses and effective doses were calculated using OLINDA/EXM. Normal organ uptake and tumor lesion uptake (SUVmax) were measured. A lesion-by-lesion analysis was performed.Results68Ga-DOTA-DiPSMA administration was safe and well-tolerated. The kidneys received the highest absorbed dose (114.46 ± 29.28 uSv/MBq), followed by the urinary bladder wall (100.82 ± 46.22 uSv/MBq) in accordance with the expected PSMA renal excretion of the tracer. The mean effective dose was 19.46 ± 1.73 μSv/MBq. The SUVmax of 68Ga-PSMA-11 and 68Ga-DOTA-DiPSMA PET/CT for PCa lesions, bone metastases, and lymph node metastases were 11.2 ± 10.76 vs. 4.41 ± 2.72, 7.6 ± 1.58 vs. 2.95 ± 1.11 and 4.86 ± 1.94 vs. 3.26 ± 1.2, respectively.ConclusionInjection of 68Ga-DOTA-DiPSMA is safe and associated with low absorbed and effective doses. Compared to 68Ga-PSMA-11, 68Ga-DOTA-DiPSMA shows comparable pharmacokinetics and detection ability in PCa patients that warrant further head-to-head comparison. Low non-specific uptake in salivary glands and kidneys of 68Ga-DOTA-DiPSMA indicates potential radioligand therapy (RLT) application when labeled with 177Lu, 90Y, or 225Ac.

Diagnostic Performance of Whole Body Dual Modality 18F-FDG PET/CT Imaging for N- and M-Staging of Malignant Melanoma: Experience With 250 Consecutive Patients

2006 ◽  
Vol 24 (7) ◽  
pp. 1178-1187 ◽  
Author(s):  
Michael J. Reinhardt ◽  
Alexius Y. Joe ◽  
Ursula Jaeger ◽  
Andrea Huber ◽  
Alexander Matthies ◽  
...  
Keyword(s):  
Cutaneous Melanoma ◽  
Fdg Pet ◽  
Diagnostic Performance ◽  
Tumor Staging ◽  
Distant Metastases ◽  
Ct Imaging ◽  
Whole Body ◽  
Positron Emission ◽  
Pet Ct ◽  
Fdg Pet Ct

Purpose To assess the diagnostic performance of positron emission tomography/computed tomography (PET/CT) using 18F-fluorodeoxyglucose (FDG) for N- and M-staging of cutaneous melanoma. Patients and Methods This is a retrospective and blinded study of 250 consecutive patients (105 women, 145 men; age 58 ± 16 years) who underwent FDG-PET/CT for staging of cutaneous melanoma at different time points in the course of disease. Whole-body FDG-PET/CT was performed 101 ± 21 minutes postinjection of 371 ± 41 MBq FDG. Diagnostic accuracy for N- and M-staging was determined for CT alone, PET alone, and PET/CT. Results PET/CT detected significantly more visceral and nonvisceral metastases than PET alone and CT alone (98.7%, 88.8%, and 69.7%, respectively). PET/CT imaging thus provided significantly more accurate interpretations regarding overall N- and M-staging than PET alone and CT alone. Overall N- and M-stage was correctly determined by PET/CT in 243 of 250 patients (97.2%; 95% CI, 95.2% to 99.4%) compared with 232 patients (92.8%; 95% CI, 89.6% to 96.0%) by PET, and 197 patients (78.8%; 95% CI, 73.7% to 83.9%) by CT. All differences were significant. Accuracy of PET/CT was significantly higher than that of PET and CT for M-staging (0.98 v 0.93 and 0.84) and significantly higher than that of CT for N-Staging (0.98 v 0.86). Change of treatment according to PET/CT findings occurred in 121 patients (48.4%). Conclusion The diagnostic performance of FDG-PET/CT for N- and M-staging of melanoma patients suggests its use for whole-body tumor staging, especially for detection or exclusion of distant metastases.

A phase III, multicenter study to assess the diagnostic performance and clinical impact of 18F-DCFPyL PET/CT in men with suspected recurrence of prostate cancer (CONDOR).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5093-TPS5093
Author(s):  
Michael J. Morris ◽  
Frederic Pouliot ◽  
Lawrence Saperstein ◽  
Steven P. Rowe ◽  
Michael A. Gorin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Diagnostic Performance ◽  
Metastatic Prostate Cancer ◽  
The United States ◽  
Clinical Impact ◽  
Phase Iii ◽  
Whole Body ◽  
Recurrent Prostate Cancer ◽  
Detection Rates ◽  
Pet Ct

TPS5093 Background: Early and accurate detection of recurrent or metastatic prostate cancer remains an unmet diagnostic need for patient management. While agents for positron emission tomography (PET), such as 11C-choline and 18F-fluciclovine, have emerged as options for imaging recurrent prostate cancer, these agents are not specific for the disease. 18F-DCFPyL is a novel, low-molecular weight, PET radiopharmaceutical that binds selectively to prostate-specific membrane antigen with high affinity. In prior studies, 18F-DCFPyL PET/CT has shown reliable diagnostic performance in detecting metastatic or recurrent prostate cancer (Rowe Mol Imaging Biol 2016 18:411-19; Gorin J Urol 2018 1999:126-32). Methods: CONDOR is a phase 3, multicenter, open-label study designed to assess the diagnostic performance and clinical impact of 18F-DCFPyL PET/CT in men with suspected recurrent or metastatic prostate cancer. Approximately 200 patients are planned to be enrolled across 15 centers in the United States and Canada. Eligible patients ≥18 years of age must have histologically confirmed prostate adenocarcinoma, have rising PSA after definitive therapy, and negative or equivocal conventional imaging. A single 9 mCi (333 MBq) dose of 18F-DCFPyL is administered, followed by whole body PET/CT scan 1 hour later. The primary objective is to assess the correct localization rate (percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and the composite truth standard, defined as either evaluable histopathology, informative correlative imaging, or PSA response after radiation therapy). Additional study objectives include safety and tolerability of 18F-DCFPyL, impact on intended treatment plans, detection rates and PPV of 18F-DCFPyL by region, and detection rates by baseline PSA. 18F-DCFPyL PET/CT results are centrally reviewed by independent readers blinded to all clinical and other imaging information. As of February 9, 2019, a total of 36 patients have been dosed in the study. Clinical trial information: NCT03739684.

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