Assessment of <sup>68</sup>Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer

Fendler, Wolfgang P.; Calais, Jérémie; Eiber, Matthias; Flavell, Robert R.; Mishoe, Ashley; Feng, Felix Y.; Nguyen, Hao G.; Reiter, Robert E.; Rettig, Matthew B.; Okamoto, Susumu; Emmett, Louise; Zacho, Helle D; Ilhan, Harun; Wetter, Axel; Rischpler, Christoph; Schöder, Heiko; Burger, Irene A.; Gartmann, J; Smith, Raven; Small, Eric J.; Slavik, Roger; Carroll, Peter R.; Herrmann, Ken; Czernin, Johannes; Hope, Thomas A.

doi:10.1001/jamaoncol.2019.0096

Cited by 596 publications

(515 citation statements)

References 37 publications

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“…Eighteen studies reported the detection rate of 68 Ga‐PSMA PET in patients with a PSA 0.20–0.49 ng/mL . Combined, this involved 1078 patients.…”

Section: Resultsmentioning

confidence: 99%

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Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

Luiting¹,

Leeuwen

Busstra³

et al. 2019

BJU International

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ObjectivesTo review the literature to determine the sensitivity and specificity of gallium-68 prostate-specific membrane antigen ( 68 Ga-PSMA) positron-emission tomography (PET) for detecting pelvic lymph node metastases in patients with primary prostate cancer (PCa), and the positive predictive value in patients with biochemical recurrence (BCR) after initial curative treatment, and, in addition, to determine the detection rate and management impact of 68 Ga-PSMA PET in patients with BCR after radical prostatectomy (RP). Materials and MethodsWe performed a comprehensive literature search. Search terms used in MEDLINE, EMBASE and Science Direct were '(PSMA, 68 Ga-PSMA, 68 Gallium-PSMA, Ga-68-PSMA or prostate-specific membrane antigen)' and '(histology, lymph node, staging, sensitivity, specificity, positive predictive value, recurrence, recurrent or detection)'. Relevant abstracts were reviewed and full-text articles obtained where possible. References to and from obtained articles were searched to identify further relevant articles. ResultsNine retrospective and two prospective studies described the sensitivity and specificity of 68 Ga-PSMA PET for detecting pelvic lymph node metastases before initial treatment, which ranged from 33.3% to 100% and 80% to 100%, respectively. In eight retrospective studies, the positive predictive value of 68 Ga-PSMA PET in patients with BCR before salvage lymph node dissection ranged from 70% to 100%. The detection rate of 68 Ga-PSMA PET in patients with BCR after RP in the PSA subgroups <0.2 ng/mL, 0.2-0.49 ng/mL and 0.5 to <1.0 ng/ mL ranged from 11.3% to 50.0%, 20.0% to 72.7% and 25.0% to 87.5%, respectively. ConclusionThe review results showed that 68 Ga-PSMA PET had a high specificity for the detection of pelvic lymph node metastases in primary PCa. Furthermore, 68 Ga-PSMA PET had a very high positive predictive value in detecting lymph node metastases in patients with BCR. By contrast, sensitivity was only moderate; therefore, based on the currently available literature, 68 Ga-PSMA PET cannot yet replace pelvic lymph node dissection to exclude lymph node metastases. In the salvage phase, 68 Ga-PSMA PET had both a high detection rate and impact on radiotherapy planning in early BCR after RP. Keywords 68Ga-PSMA PET/CT, pelvic lymph node dissection, detection rate, pelvic lymph node metastases, #ProstateCancer, #PCSM Use of 68Ga-PSMA PET/CT after RP: review IQR, interquartile range; LNM, lymph node metastases. *Gallium-68 prostate-specific membrane antigen positron-emission tomography ( 68 Ga-PSMA PET)/MRI was used instead of 68 Ga-PSMA PET/CT. 208

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“…Eighteen studies reported the detection rate of 68 Ga‐PSMA PET in patients with a PSA 0.20–0.49 ng/mL . Combined, this involved 1078 patients.…”

Section: Resultsmentioning

confidence: 99%

“…Of these 567 patients, 367 (64.7%) had a positive 68 Ga‐PSMA PET. The detection rate ranged from 25% to 87.5% .…”

Section: Resultsmentioning

confidence: 99%

Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

Luiting¹,

Leeuwen

Busstra³

et al. 2019

BJU International

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“…6 PSMA positron emission tomography (PET) imaging has demonstrated superiority to traditional imaging in the initial staging of intermediate-and high-risk disease 7 and in the detection of biochemical relapse in patients with low PSA values. 8,9 PSMA imaging using the radiotracer, 18 F-DCFPyL, also demonstrated improved sensitivity and specificity over conventional imaging modalities in the metastatic castration-resistant space. 10 Most metastatic prostate cancers spread through the blood as circulating tumor cells (CTCs), and enumeration of CTCs correlates with baseline and postbaseline prognosis in the mCRPC population.…”

Section: Introductionmentioning

confidence: 98%

“…PSMA‐targeted radioligand therapies, including 177 Lu‐PSMA‐617, successfully deliver β‐radiation directly to PCa cells . PSMA positron emission tomography (PET) imaging has demonstrated superiority to traditional imaging in the initial staging of intermediate‐ and high‐risk disease and in the detection of biochemical relapse in patients with low PSA values . PSMA imaging using the radiotracer,F‐DCFPyL, also demonstrated improved sensitivity and specificity over conventional imaging modalities in the metastatic castration‐resistant space …”

Section: Introductionmentioning

confidence: 99%

A pilot study of prostate‐specific membrane antigen (PSMA) dynamics in men undergoing treatment for advanced prostate cancer

et al. 2019

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Background Prostate‐specific membrane antigen (PSMA) is a rational target for noninvasive detection of recurrent prostate cancer (PCa) and for therapy of metastatic castration‐resistant prostate cancer (mCRPC) with PSMA‐targeted agents. Here we conducted serial measurements of PSMA expression on circulating tumor cells (CTCs) to evaluate patterns of longitudinal PSMA dynamics over the course of multiple sequential therapies. Methods A retrospective investigation of men with mCRPC undergoing evaluation at medical oncology clinics at our institution assessed the dynamics of PSMA expression in the context of different systemic treatments administered sequentially. Eligibility included patients who began systemic therapies with androgen receptor (AR)‐directed agents or taxane agents for whom peripheral blood samples were tested for CTC mRNA of AR splice variant‐7 (AR‐V7), prostate‐specific antigen (PSA), and PSMA (with >2 CTC + results) in a CLIA‐accredited laboratory. Results From August 2015 to November 2017, we identified 96 eligible men. Fifteen had greater than or equal to 2 sequential therapies and evaluable CTC samples, greater than or equal to 1 expressing PSMA (PSMA+). Among the 15 patients included in this analysis, a total of 54 PSMA status evaluations were performed in the context of 48 therapies during a median follow‐up of 18 months. At baseline, PSMA signal was detected (“positive”) in 11 of 15 (73.3%) patients, while for 4 of 15 (26.7%) patients PSMA signal was undetectable (“negative”). In all but two patients, the baseline collection corresponded with a change in treatment. On the second assessment, PSMA increases were detected in all 4/4 (100%) PSMA‐negative patients and 8 of 11 (72.7%) PSMA‐positive patients. PSMA significantly decreased in a patient treated with 177Lu‐PSMA‐617. Serum PSA declines were seen in 7 of 8 (88%) of the treatment periods where PSMA decreased. Conclusions PSMA expression in CTCs is a dynamic marker. PSMA transcript declines appear to be associated with concurrent decreases in serum PSA. Sequential CTC sampling could provide a noninvasive response assessment to systemic treatment for mCRPC.

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“…Prostate-specific membrane antigen (PSMA) is a cell surface transmembrane glycoprotein expressed on the cell surface by the majority of PCa cells, with its expression increasing in higher-grade malignancy [11,12]. Recently, PSMA-positron-emission tomography (PET)/CT imaging has become increasingly used in the detection of metastatic disease, especially in patients with biochemical recurrence after local treatment [13][14][15][16][17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

Protocol for the PRIMARY clinical trial, a prospective, multicentre, cross‐sectional study of the additive diagnostic value of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography/computed tomography to multiparametric magnetic resonance imaging in the diagnostic setting for men being investigated for prostate cancer

et al. 2020

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Objectives Primary objectives: To determine the additive value of gallium‐68 prostate‐specific membrane antigen (PSMA) positron emission topography (PET)/computed tomography (CT) when combined with multiparametric magnetic resonance imaging (mpMRI) detecting clinically significant prostate cancer (csPCa) in men undergoing initial biopsy for suspicion of PCa, and to determine the proportion of men who could have avoided prostate biopsy with positive mpMRI (PI‐RADS ≥3) but negative PSMA‐PET/CT. Secondary objectives: To determine the proportion of men who had csPCa detected only by PSMA‐PET/CT or only by systematic prostate biopsy; to compare index lesions by template biopsies vs targeted lesions identified on mpMRI or PSMA‐PET/CT; to assess whether there may be health economic benefit or harm if PSMA‐PET/CT is incorporated into the diagnostic algorithm; and to develop a nomogram which combines clinical, imaging and biomarker data to predict the likelihood of csPCa. Patients and Methods The PRIMARY trial is a multicentre, prospective, cross‐sectional study that meets the criteria for level 1 evidence in diagnostic test evaluation. PRIMARY will investigate if a limited (pelvic‐only) PSMA‐PET/CT in combination with routine mpMRI can reliably discriminate men with csPCa from those without csPCa. We conducted a power calculation based on pilot data and will recruit up to 600 men who will undergo PSMA‐PET/CT (the index test), mpMRI (standard test) and transperineal template + targeted (PSMA‐PET/CT and/or mpMRI) biopsies (reference test). The conduct and reporting of the mpMRI and PSMA‐PET/CT will be blinded to each other. Results The PRIMARY trial will measure and compare sensitivity, specificity, positive predictive value and negative predictive value of both mpMRI and PSMA‐PET/CT vs targeted prostrate biopsy. The results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of csPCa. Furthermore, we will assess whether there is a health economic benefit in incorporating PSMA‐PET/CT into the diagnostic algorithm. Conclusions This trial will provide robust prospective data to determine the diagnostic ability of PSMA‐PET/CT used in addition to mpMRI. It will establish if certain patients can avoid biopsy in the investigation of PCa.

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Assessment of ⁶⁸Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer

Abstract: In retrospective studies, 68 Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging. OBJECTIVE To assess 68 Ga-PSMA-11 PET accuracy in a prospective multicenter trial.

Cited by 596 publications

References 37 publications

Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

A pilot study of prostate‐specific membrane antigen (PSMA) dynamics in men undergoing treatment for advanced prostate cancer

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Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer

Abstract: In retrospective studies, 68 Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging. OBJECTIVE To assess 68 Ga-PSMA-11 PET accuracy in a prospective multicenter trial.

Cited by 596 publications

References 37 publications

Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

Use of gallium‐68 prostate‐specific membrane antigen positron‐emission tomography for detecting lymph node metastases in primary and recurrent prostate cancer and location of recurrence after radical prostatectomy: an overview of the current literature

A pilot study of prostate‐specific membrane antigen (PSMA) dynamics in men undergoing treatment for advanced prostate cancer

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Assessment of ⁶⁸Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer