To make magnetic resonance imaging (MRI) more accessible to men at risk of high-grade prostate cancer (PCa), there is a need for quicker, simpler, and less costly MRI protocols.
To compare the ...diagnostic performance of monoplanar (“fast” biparametric MRI bp-MRI) and triplanar noncontrast bp-MRI with that of the current contrast-enhanced multiparametric MRI (mp-MRI) in the detection of high-grade PCa in biopsy-naïve men.
A prospective, multireader, head-to-head study included 626 biopsy-naïve men, between February 2015 and February 2018.
Men underwent prebiopsy contrast-enhanced mp-MRI. Prior to biopsy, two blinded expert readers subsequently assessed “fast” bp-MRI, bp-MRI, and mp-MRI. Thereafter, systematic transrectal ultrasound-guided biopsies (SBs) were performed. Men with suspicious mp-MRI (Prostate Imaging Reporting and Data System 3–5 lesions) also underwent MR-in-bore biopsy (MRGB).
Primary outcome was the diagnostic performance of each protocol for the detection of high-grade PCa. Secondary outcomes included the difference in biopsy avoidance, detection of low-grade PCa, acquisition times, decision curve analyses, inter-reader agreement, and direct costs. Results from combined MRGB and SB were used as the reference standard. High-grade PCa was defined as grade ≥2.
Sensitivity for high-grade PCa for all protocols was 95% (180/190; 95% confidence interval CI: 91–97%). Specificity was 65% (285/436; 95% CI: 61–70%) for “fast” bp-MRI and 69% (299/436; 95% CI: 64–73%) for bp-MRI and mp-MRI. With fast bp-MRI, 0.96% (6/626) more low-grade PCa was detected. Biopsy could be avoided in 47% for the fast bp-MRI and in 49% for the bp-MRI and mp-MRI protocols. Fast bp-MRI and bp-MRI can be performed in 8 and 13min, respectively, instead of 16min at lower direct costs. Inter-reader agreement was 90% for fast bp-MRI protocol and 93% for bp-MRI protocol. A main limitation is the generalizability of these results in less experienced centers.
Short MRI protocols can improve prostate MRI accessibility at a lower direct cost. For fast bp-MRI, this is at the cost of ∼2% more biopsies and ∼1% more overdetection of low-grade PCa. In order to implement this technique in nonexpert, low-volume, lower-field-strength scanners, further prospective studies have to be performed.
We compared the value of three different magnetic resonance imaging (MRI) protocols for the detection of prostate cancer in men with elevated prostate-specific antigen levels. Our results show that, when used in expert centers, shorter MRI protocols do not compromise the detection of harmful disease. This increases MRI capacity at lower direct costs.
Short magnetic resonance imaging (MRI) protocols improves prostate MRI accessibility at a lower direct-cost: twice as fast bi-parametric MRI is as accurate as multi-parametric MRI, only at the cost of 2% more biopsies and 1% more over-detection of low-grade prostate cancer.
Abstract Objectives To assess 3-Tesla (3-T) ultra-small superparamagnetic iron oxide (USPIO)-enhanced MRI in detecting lymph node (LN) metastases for resectable adenocarcinomas of the pancreas, ...duodenum, or periampullary region in a node-to-node validation against histopathology. Methods Twenty-seven consecutive patients with a resectable pancreatic, duodenal, or periampullary adenocarcinoma were enrolled in this prospective single expert centre study. Ferumoxtran-10-enhanced 3-T MRI was performed pre-surgery. LNs found on MRI were scored for suspicion of metastasis by two expert radiologists using a dedicated scoring system. Node-to-node matching from in vivo MRI to histopathology was performed using a post-operative ex vivo 7-T MRI of the resection specimen. Sensitivity and specificity were calculated using crosstabs. Results Eighteen out of 27 patients (median age 65 years, 11 men) were included in the final analysis (pre-surgery withdrawal n = 4, not resected because of unexpected metastases peroperatively n = 2, and excluded because of inadequate contrast-agent uptake n = 3). On MRI 453 LNs with a median size of 4.0 mm were detected, of which 58 (13%) were classified as suspicious. At histopathology 385 LNs with a median size of 5.0 mm were found, of which 45 (12%) were metastatic. For 55 LNs node-to-node matching was possible. Analysis of these 55 matched LNs, resulted in a sensitivity and specificity of 83% (95% CI: 36–100%) and 92% (95% CI: 80–98%), respectively. Conclusion USPIO-enhanced MRI is a promising technique to preoperatively detect and localise LN metastases in patients with pancreatic, duodenal, or periampullary adenocarcinoma. Clinical relevance statement Detection of (distant) LN metastases with USPIO-enhanced MRI could be used to determine a personalised treatment strategy that could involve neoadjuvant or palliative chemotherapy, guided resection of distant LNs, or targeted radiotherapy. Registration The study was registered on clinicaltrials.gov NCT04311047. https://clinicaltrials.gov/ct2/show/NCT04311047?term=lymph+node&cond=Pancreatic+Cancer&cntry=NL&draw=2&rank=1 . Key Points LN metastases of pancreatic, duodenal, or periampullary adenocarcinoma cannot be reliably detected with current imaging . This technique detected LN metastases with a sensitivity and specificity of 83% and 92%, respectively . MRI with ferumoxtran-10 is a promising technique to improve preoperative staging in these cancers .
Ultrasmall superparamagnetic iron oxide (USPIO)-enhanced magnetic resonance imaging (MRI) is a potential diagnostic tool for lymph node assessment in patients with head and neck cancer. Validation by ...radiologic-pathologic correlation is essential before the method is evaluated in clinical studies. In this study, MRI signal intensity patterns of lymph nodes are correlated to their histopathology to develop a new USPIO-enhanced MRI reading algorithm that can be used for nodal assessment in head and neck cancer patients.
Ten head and neck cancer patients underwent in vivo USPIO-enhanced MRI before neck dissection. An ex vivo MRI of the neck dissection specimen was performed for precise coregistration of in vivo MRI with histopathology. Normal clinical histopathological workup was extended with meticulous matching of all lymph nodes regarded as potentially metastatic based on their in vivo MRI signal intensity pattern. On the basis of histopathology of resected nodes, in vivo MRI signal characteristics were defined separating benign from malignant lymph nodes.
Fifteen of 34 node-to-node correlated lymph nodes with remaining signal intensity on T2*-weighted MRI were histopathologically metastatic and 19 were benign. Radiological analysis revealed that metastatic lymph nodes showed equal or higher MRI signal intensity when compared with lipid tissue on T2*-weighted MGRE sequence (15/16 lymph nodes; 94%), whereas healthy lymph nodes showed lower (17/19 lymph nodes; 89%) or complete attenuation of signal intensity (273/279; 98%) when compared with lipid tissue on T2*-weighted MGRE. Histopathology of all resected specimens identified 392 lymph nodes. Six lymph nodes with (micro)metastases were missed with in vivo MRI. Whether these 6 lymph nodes were correlated to a nonmalignant lymph node on in vivo MRI or could not be detected at all is unclear.
We developed a new reading algorithm to differentiate benign from malignant lymph nodes in head and neck cancer patients on the basis of their appearance on high-resolution T2*-weighted USPIO-enhanced MRI. Next steps involve validation of our reading algorithm to further improve the accuracy of neck lymph node staging with USPIO-enhanced MRI in prospective clinical studies with larger number of patients.
Objective
To assess the outcomes of pre‐biopsy magnetic resonance imaging (MRI) pathways, as a tool in biopsy‐naïve men with suspicion of prostate cancer, in routine clinical practice. Secondary ...outcomes included a comparison of transrectal MRI‐directed biopsy (TR‐MRDB) and transperineal (TP)‐MRDB in men with suspicious MRI.
Patients and Methods
We retrospectively assessed a two‐centre cohort of consecutive biopsy‐naïve men with suspicion of prostate cancer who underwent a Prostate Imaging‐Reporting and Data System version 2 (PI‐RADS v2) compliant pre‐biopsy MRI in a single, high‐volume centre between 2015 and 2019 (Centre 1). Men with suspicious MRI scans underwent TR‐MRDB in Centre 1 and TP‐MRDB with additional random biopsies (RB) in Centre 2. The MRI and histopathology were assessed in the same institution (Centre 1). Outcomes included: (i) overall detection rates of Grade Group (GG) 1, GG ≥2, and GG ≥3 cancer in men with suspicious MRI; (ii) Biopsy‐avoidance due to non‐suspicious MRI; and (iii) Cancer detection rates and biopsy‐related complications between TR‐ and TP‐MRDB. To reduce confounding bias for MRDB comparisons, inverse probability weighting (IPW) was performed for age, digital rectal examination, prostate‐specific antigen (PSA), prostate volume, PSA density, and PI‐RADS category.
Results
Of the 2597 men included, the overall GG 1, GG ≥2, and GG ≥3 prevalence was 8% (210/2597), 27% (697/2597), and 15% (396/2597), respectively. Biopsy was avoided in 57% (1488/2597) of men. After IPW, the GG 1, GG ≥2 and GG ≥3 detection rates after TR‐ and TP‐MRDB were comparable at 24%, 57%, and 32%; and 18%, 64%, and 38%, respectively; with mean differences of −5.7% (95% confidence interval CI −13% to 1.4%), 6.1% (95% CI −2.1% to 14%), and 5.7% (95% CI −1.7% to 13%). Complications were similar in TR‐MRDB (0.50%) and TP‐MRDB with RB (0.62%; mean difference 0.11%, 95% CI −0.87% to 1.1%).
Conclusion
This high‐volume, two‐centre study shows pre‐biopsy MRI as a decision tool is implementable in daily clinical practice. Compared to recent trials, a substantially higher biopsy avoidance rate was achieved without compromising GG ≥2/GG ≥3 detection and coinciding with lower over detection rates of GG 1 cancer. Prostate cancer detection and complication rates were comparable for TR‐ and TP‐MRDB.
Abstract
Background
The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if
177
Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive ...prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial.
Changes in methods and materials
Two important changes were made to the original protocol: (1) the study will now use
177
Lu-PSMA-617 instead of
177
Lu-PSMA-I&T and (2) responding patients with residual disease on
18
F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq
177
Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving
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Lu-PSMA-617 will also receive an interim
18
F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; “Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer” and is now partly supported by Advanced Accelerator Applications, a Novartis Company.
Conclusions
We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received
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Lu-PSMA-I&T under the previous protocol will be replaced.
Trial registration
ClinicalTrials.gov
NCT04443062
. First posted: June 23, 2020.
There is large variability among radiologists in their detection of clinically significant (cs) prostate cancer (PCa) on multiparametric magnetic resonance imaging (mpMRI).
To reduce the ...interpretation variability and achieve optimal accuracy in assessing prostate mpMRI.
How the interpretation of mpMRI can be optimized is demonstrated here. Whereas part 1 of the “surgery-in-motion” paper focused on acquisition, this paper shows the correlation between (ab)normal prostate anatomical structures and image characteristics on mpMRI, and how standardized interpretation according to Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) should be performed. This will be shown in individual patients.
To detect csPCa, three mpMRI “components” are used: “anatomic” T2-weighted imaging, “cellular-density” diffusion-weighted imaging, and “vascularity” dynamic contrast-enhanced MRI.
Based on PI-RADS v2, the accompanying video shows how mpMRI interpretation is performed. Finally, the role of mpMRI in detecting csPCa is briefly discussed and the main features of the recently introduced PI-RADS v2.1 are evaluated.
With PI-RADS v2, it is possible to quantify normal and abnormal anatomical structures within the prostate based on its imaging features of the three mpMRI “components.” With this knowledge, a more objective evaluation of the presence of a csPCa can be performed. However, there still remains quite some space to reduce interobserver variability.
For understanding the interpretation of mpMRI according to PI-RADS v2, knowledge of the correlation between imaging and (ab)normal anatomical structures on the three mpMRI components is needed.
This second surgery-in-motion contribution shows what structures can be recognized on prostate magnetic resonance imaging (MRI). How a radiologist performs his reading according to the so-called Prostate Imaging Reporting and Data System criteria is shown here. The main features of these criteria are summarized, and the role of prostate MRI in detecting clinically significant prostate cancer is discussed briefly.
This paper provides insight into what structures of normal and abnormal prostates are visible with multiparametric magnetic resonance imaging (mpMRI). To detect clinically significant prostate cancer, three mpMRI “components” must be used: “anatomic” T2-weighted imaging, “cellular density” diffusion-weighted imaging, and “vascularity” dynamic contrast–enhanced MRI. Based on these images, mpMRI interpretation according to the Prostate Imaging Reporting and Data System is done.
PSMA-PET is a novel imaging modality for the staging of prostate cancer (PCa). While there are several PSMA ligands available, F-18-PSMA-1007 is particularly of interest as it is not renally excreted ...and therefore does not impair the imaging of the pelvic area. Hence, this study aimed to investigate the F-18-PSMA-1007-PET for the primary staging of PCa and compared it to multi-parametric (mp) MRI and histopathology.
A retrospective study was performed of men with intermediate and high-risk PCa patients that underwent a F-18-PSMA-1007-PET after mpMRI with subsequent MR-guided target biopsy (MRGB). Suspicious mpMRI lesions and F-18-PSMA-1007-PET were simultaneously reviewed on both a per patient and per-lesion basis. Results were subsequently evaluated with histopathological outcome of MRGB, and if performed, the radical prostatectomy specimen.
A total of 66 suspicious mpMRI lesions were identified in 53 patients and underwent MRGB. Two lesions had a maximum standardized uptake value (SUV
) less than the mean SUV
of healthy prostate tissue and were considered as non-PSMA-expressing. All PSMA avid tumors had higher SUV
than the mean SUV
of the bladder/urine, therefore all lesions were clearly distinguishable in the pelvic area. Twenty-three patients received a radical prostatectomy of which the histopathology specimens were evaluated. F-18-PSMA-1007-PET/CT correctly staged seminal vesicle invasion (i.e. pT3b) more often than mpMRI (90 vs. 76%), whereas mpMRI more accurately detected extracapsular extension (i.e. pT3a) compared to F-18-PSMA-1007-PET (90% vs 57%).
The present study of a selected cohort suggest that dual imaging with mpMRI and F-18-PSMA-1007-PET may improve staging of primary PCa. F-18-PSMA-1007-PET/CT had low renal clearance, which could assist the evaluation of tumors in proximity of the bladder.
LuLu-PSMA-617 radioligand therapy (
Lu-PSMA) is a novel treatment for metastatic castration-resistant prostate cancer (mCRPC), which could also be applied to patients with metastatic ...hormone-sensitive prostate cancer (mHSPC) with PSMA expression. In this prospective study (NCT03828838), we analyzed toxicity, radiation doses, and treatment effect of
Lu-PSMA in pateints with low-volume mHSPC.
Ten progressive patients with mHSPC following local treatment, with a maximum of ten metastatic lesions on
GaGa-PSMA-11 PET/diagnostic-CT imaging (PSMA-PET) and serum PSA doubling time <6 months received two cycles of
Lu-PSMA. Whole-body single-photon emission CT/CT (SPECT/CT) and blood dosimetry was performed to calculate doses to the tumors and organs at risk (OAR). Adverse events (AE), laboratory values (monitoring response and toxicity), and quality of life were monitored until week 24 after cycle 2, the end of study (EOS). All patients underwent PSMA-PET at screening, 8 weeks after cycle 1, 12 weeks after cycle 2, and at EOS.
All patients received two cycles of
Lu-PSMA without complications. No treatment-related grade III-IV adverse events were observed. According to dosimetry, none of the OAR reached threshold doses for radiation-related toxicity. Moreover, all target lesions received a higher radiation dose than the OAR. All 10 patients showed altered PSA kinetics, postponed androgen deprivation therapy, and maintained good quality of life. Half of the patients showed a PSA response of more than 50%. One patient had a complete response on PSMA-PET imaging until EOS and two others had only minimal residual disease.
Lu-PSMA appeared to be a feasible and safe treatment modality in patients with low-volume mHSPC.
In head and neck cancer, the presence of nodal disease is a strong determinant of prognosis and treatment. Despite the use of modern multimodality diagnostic imaging, the prevalence of occult nodal ...metastases is relatively high. This is why in clinically node negative head and neck cancer the lymphatics are treated "electively" to eradicate subclinical tumor deposits. As a consequence, many true node negative patients undergo surgery or irradiation of the neck and suffer from the associated and unnecessary early and long-term morbidity. Safely tailoring head and neck cancer treatment to individual patients requires a more accurate pre-treatment assessment of nodal status. In this review, we discuss the potential of several innovative diagnostic approaches to guide customized management of the clinically negative neck in head and neck cancer patients.
In recent years, there is increasing evidence showing a beneficial outcome (e.g. progression free survival; PFS) after metastases-directed therapy (MDT) with external beam radiotherapy (EBRT) or ...targeted surgery for oligometastatic hormone sensitive prostate cancer (oHSPC). However, many patients do not qualify for these treatments due to prior interventions or tumor location. Such oligometastatic patients could benefit from radioligand therapy (RLT) with
Lu-PSMA; a novel tumor targeting therapy for end-stage metastatic castration-resistant prostate cancer (mCRPC). Especially because RLT could be more effective in low volume disease, such as the oligometastatic status, due to high uptake of radioligands in smaller lesions. To test the hypothesis that
Lu-PSMA is an effective treatment in oHSPC to prolong PFS and postpone the need for androgen deprivation therapy (ADT), we initiated a multicenter randomized clinical trial. This is globally, the first prospective study using
Lu-PSMA-I&T in a randomized multicenter setting.
This study compares
Lu-PSMA-I&T MDT to the current standard of care (SOC); deferred ADT. Fifty-eight patients with oHSPC (≤5 metastases on PSMA PET) and high PSMA uptake (SUVmax > 15, partial volume corrected) on
F-PSMA PET after prior surgery and/or EBRT and a PSA doubling time of < 6 months, will be randomized in a 1:1 ratio. The patients randomized to the interventional arm will be eligible for two cycles of 7.4GBq
Lu-PSMA-I&T at a 6-week interval. After both cycles, patients are monitored every 3 weeks (including adverse events, QoL- and xerostomia questionnaires and laboratory testing) at the outpatient clinic. Twenty-four weeks after cycle two an end of study evaluation is planned together with another
F-PSMA PET and (whole body) MRI. Patients in the SOC arm are eligible to receive
Lu-PSMA-I&T after meeting the primary study objective, which is the fraction of patients who show disease progression during the study follow up. A second primary objective is the time to disease progression. Disease progression is defined as a 100% increase in PSA from baseline or clinical progression.
This is the first prospective randomized clinical study assessing the therapeutic efficacy and toxicity of
Lu-PSMA-I&T for patients with oHSPC.
Clinicaltrials.gov identifier: NCT04443062 .
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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