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Last update 20 Mar 2025

18F-PSMA-1007

Last update 20 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms

뉴큐어엠라델루민주사액

Target

PSMA

Action

modulators

Mechanism

PSMA modulators(Prostate-specific membrane antigen modulators)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Prostatic CancerLocalized Prostate CarcinomaRecurrent Prostate Carcinoma

Inactive Indication

Glioblastoma

Originator Organization

German Cancer Research Center

Active Organization

ABX advanced biochemical compounds GmbH

Centre For Probe Development & CommercializationNewcureM

Inactive Organization

Radboud University Medical Center

Drug Highest PhaseApproved

First Approval Date

South Korea (11 Dec 2024),

Prostatic Cancer

Regulation-

Structure/Sequence

Molecular FormulaC49H55FN8O16

InChIKeyRFFFFGRYVZESLB-CXODGJKXSA-N

CAS Registry2093321-19-6

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Sequence Code 527975753

Clinical Trials associated with 18F-PSMA-1007

NCT06881823

/ Not yet recruitingPhase 1/2

NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

Start Date27 Jun 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06122584

/ RecruitingPhase 3

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

Start Date13 Jun 2024

Sponsor / Collaborator

ABX advanced biochemical compounds GmbH

CTIS2023-504026-19-01

/ RecruitingPhase 3

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer - ABX-CT-302EU/EAGLE-i

Start Date05 Jun 2024

Sponsor / Collaborator

ABX advanced biochemical compounds GmbH

100 Clinical Results associated with 18F-PSMA-1007

100 Translational Medicine associated with 18F-PSMA-1007

100 Patents (Medical) associated with 18F-PSMA-1007

Literatures (Medical) associated with 18F-PSMA-1007

12 Dec 2023·BJR|Open

The quantitative impact of prostate-specific membrane antigen (PSMA) PET/CT staging in newly diagnosed metastatic prostate cancer and treatment-decision implications

Article

Author: Yogeswaran, Yathushan ; Abdel-Aty, Hoda ; van As, Nicholas ; James, Nicholas ; Murray, Iain ; Hujairi, Nabil

AbstractObjectivesTo quantify the stage-shift with prostate-specific membrane antigen (PSMA) PET/CT imaging in metastatic prostate cancer and explore treatment implications.MethodsSingle-centre, retrospective analysis of patients with newly diagnosed [18F]PSMA-1007 or [68Ga]Ga-PSMA-11 PET/CT-detected metastatic prostate cancer who had baseline bone scintigraphy between January 2015 and May 2021. Patients were subclassified into oligometastatic and polymetastatic disease utilizing the STAMPEDE2 trial (ISRCTN66357938/NCT06320067) definition. Patient, tumour, and treatment characteristics were collected. PSMA PET/CT concordance with conventional imaging (bone scintigraphy and low-dose CT of PET) was identified by number and site of metastases, and subgroup assigned. Spearman’s rank correlation and linear regression modelling determined the association between the imaging modalities.ResultsWe analysed 62 patients with a median age was 72 years (range 48-86). On PSMA PET/CT, 31/62 (50%) patients had oligometastatic disease, and 31/62 (50%) had polymetastatic disease. Prostate radiotherapy was delivered in 20/31 (65%) patients with oligometastatic disease and 17/31 (55%) with polymetastatic disease. 23/62 (37%) patients were reclassified as M0 on conventional imaging. PSMA PET/CT had a 2.9-fold increase in detecting bone metastases. Bone metastases concordance was found in 10/50 (20%) by number and 30/33 (91%) by site. PSMA PET/CT had a 2.2-fold increase in detecting nodal metastases. Nodal metastases concordance was found in 5/46 (11%) by number and 25/26 (96%) by site. There was significant positive correlation between PSMA PET/CT and conventional imaging for detecting bone [R2 = 0.25 (P < 0.001)] and nodal metastases [R2 = 0.19 (P < 0.001)]. 16/31 (52%) had oligometastatic disease concordance.ConclusionThe magnitude of PSMA PET/CT-driven stage-shift is highly variable and unpredictable with implications on treatment decisions, future trial design, and potentially clinical outcomes.Advances in knowledgeThe magnitude of “frame-shift” with PSMA PET/CT imaging is highly variable and unpredictable which may unreliably change treatment decisions dependent on image-defined disease extent. Prospective randomized trials are required to determine the relationship between PSMA PET/CT-guided treatment choices and outcomes.

01 Jul 2023·Clinical nuclear medicine

Comparing the Detection Performance Between Multiparametric Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen PET/CT in Patients With Localized Prostate Cancer: A Systematic Review and Meta-analysis.

Review

Author: Chen, Li-Yu ; Huang, Ya-Yao ; Wang, Yuh-Feng ; Chang, Chi-Wei ; Huang, Ya-Ting ; Lo, Chun-Yu ; Huang, Yi-Hsiu

PURPOSEMultiparametric MRI (mpMRI) has been promoted as an auxiliary diagnostic tool for prostate biopsy. However, prostate-specific membrane antigen (PSMA) including 68 Ga-PSMA-11, 18 F-DCFPyL, and 18 F-PSMA-1007 applied PET/CT imaging was an emerging diagnostic tool in prostate cancer patients for staging or posttreatment follow-up, even early detecting. Many studies have used PSMA PET for comparison with mpMRI to test the diagnostic ability for early prostate cancer. Unfortunately, these studies have shown conflicting results. This meta-analysis aimed to compare the differences in diagnostic performance between PSMA PET and mpMRI for detecting and T staging localized prostatic tumors.METHODSThis meta-analysis involved a systematic literature search of PubMed/MEDLINE and Cochrane Library databases. The pooling sensitivity and specificity of PSMA and mpMRI verified by pathological analysis were calculated and used to compare the differences between the 2 imaging tools.RESULTSOverall, 39 studies were included (3630 patients in total) from 2016 to 2022 in the current meta-analysis and found that the pooling sensitivity values for localized prostatic tumors and T staging T3a and T3b of PSMA PET were 0.84 (95% confidence interval [CI], 0.83-0.86), 0.61 (95% CI, 0.39-0.79), and 0.62 (95% CI, 0.46-0.76), respectively, whereas those of mpMRI were found to be 0.84 (95% 0.78-0.89), 0.67 (95% CI, 0.52-0.80), and 0.60 (95% CI, 0.45-0.73), respectively, without significant differences ( P > 0.05). However, in a subgroup analysis of radiotracer, the pooling sensitivity of 18 F-DCFPyL PET was higher than mpMRI (relative risk, 1.10; 95% CI, 1.03-1.17; P < 0.01).CONCLUSIONSThis meta-analysis found that whereas 18 F-DCFPyL PET was superior to mpMRI at detecting localized prostatic tumors, the detection performance of PSMA PET for localized prostatic tumors and T staging was comparable to that of mpMRI.

17 May 2023·Cancers

Intra-Individual Comparison of Physiologic [⁶⁸Ga]Ga-PSMA-11 and [¹⁸F]PSMA-1007 Uptake in Ganglia in Patients with Prostate Cancer: A Retrospective, Monocentric Analysis.

Article

Author: Albers, Peter ; Mattes-György, Katalin ; Giesel, Frederik L ; Mori, Yuriko ; Radtke, Jan Philipp ; Antke, Christina ; Mamlins, Eduards ; Schimmöller, Lars ; Antoch, Gerald ; Novruzov, Emil ; Niegisch, Günter ; Dabir, Mardjan ; Schmitt, Dominik ; Beu, Markus

BACKGROUNDSeveral studies indicate, particularly in the case of [18F]PSMA-1007, a relatively high rate of detection of ganglia in PSMA PET imaging. Ganglia are an integral part of the sympathetic portion of the autonomous nervous system. To date, no studies have directly compared [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 ganglionic uptake intra-individually and analyzed the underlying molecular and physical mechanisms of different detection rates. With this monocentric retrospective study, we sought to evaluate the intra-individual physiological ganglion uptake of these different PSMA ligands in evidence-based imaging for prostate cancer.METHODSOur cohort consists of 19 male patients (median age 72 ± 9 with a range of 56-85) with biochemical recurrence of prostate cancer who underwent both [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 PET/CT in our clinic on the same scanner per standard care between March 2015 and March 2022. Tracer uptake was quantified according to maximum standardized uptake value (SUV_max) for both [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 PET/CT scans. Ganglia-to-background ratios (GBRs) were determined to quantify the image contrast through dividing the SUV_max of the ganglia by the background value (SUV_max of blood pool in the descending aorta, fatty tissue, and skeletal muscle in gluteal region). We used descriptive analyses for demographics and tumor characteristics and performed two-way repeated-measures ANOVA (analysis of variance) for SUV metrics including GBR measurements.RESULTSIn total, we examined 101 ganglia with [¹⁸F]PSMA-1007 scanning, localized mostly in pairs as stellate, coeliac, and sacral, of which 76 were also detected with [⁶⁸Ga]Ga-PSMA-11 PET/CT scanning. There was no statistically significant difference in PSMA uptake in terms of SUV_max between [¹⁸F]PSMA-1007 and [⁶⁸Ga]Ga-PSMA-11 (p value: 0.052). In contrast, the comparison of GBRs revealed a higher detectability rate of ganglia with [¹⁸F]PSMA-1007 imaging (p < 0.001). Furthermore, a separate comparison of ganglia with respect to their anatomical location also demonstrated statistically significant differences both within and between [¹⁸F]PSMA-1007 and [⁶⁸Ga]Ga-PSMA-11 PET/CT scans.CONCLUSIONGiven the impression of more accentuated [¹⁸F]PSMA-1007 uptake in ganglia compared with ⁶⁸Ga-labelled counterparts, our study demonstrated that the better detectability of ganglia is not due to more intense [¹⁸F]PSMA-1007 uptake by these small structures but to much more favorable physical properties of the radionuclide ¹⁸F. The most relevant limitations of our study are its retrospective design and the small patient cohort.

News (Medical) associated with 18F-PSMA-1007

10 Sep 2024

·www.globenewswire.com

Curium Announces PYLCLARI® – An Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer – Is Now Available in Spain

PARIS, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that in Spain, PYLCLARI® is now available for patients with prostate cancer. PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Benoit Woessmer, PET Europe CEO at Curium commented, “The availability of PYLCLARI® in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI® continues to grow and now covers seven countries including Austria, France, Germany, Greece, Italy, the Netherlands, and Spain.” In Spain, prostate cancer is one of the most common cancers among men with around 30,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced by Curium at two sites in Madrid and one site in Sevilla, ensuring timely and efficient distribution across the country. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com

Drug ApprovalRadiation Therapy

11 Jul 2024

·www.drugs.com

18F-PSMA-1007 PET/CT Superior to MRI for Staging Prostate Cancer

THURSDAY, July 11, 2024 -- For men undergoing locoregional staging of prostate cancer, fluorine-18 prostate-specific membrane antigen-1007 positron emission tomography/computed tomography ( 18 F-PSMA-1007 PET/CT) is superior to multiparametric magnetic resonance imaging (MRI), according to a study published online July 1 in JAMA Oncology to coincide with the annual meeting of the Canadian Urological Association, held from June 29 to July 1 in Victoria. Nikhile Mookerji, M.D., from the University of Alberta in Edmonton, Canada, and colleagues determined the accuracy of 18 F-PSMA-1007 PET/CT compared to multiparametric MRI in the primary locoregional staging of intermediate- and high-risk prostate cancers in the Next Generation Trial, a phase 2 study. Patients underwent all imaging studies and radical prostatectomies at two tertiary care hospitals; 134 of 150 eligible men with prostate cancer underwent radical prostatectomy. The researchers found that compared with MRI, PSMA PET was significantly superior for the accurate identification of the final pathological tumor stage (45 versus 28 percent, respectively). In addition, PSMA PET was significantly superior for the correct identification of the dominant nodule (94 versus 83 percent), laterality (64 versus 44 percent), and extracapsular extension (75 versus 63 percent) compared with MRI but was not significantly superior for correct identification of seminal vesicle invasion. "Future research should address the accuracy of combining PET/CT and MRI as well as cost effectiveness of PET/CT for the primary staging of men with prostate cancer," the authors write. Abstract/Full Text More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 2Radiation Therapy

17 Jun 2024

·www.globenewswire.com

Curium Continues to Make Strong Progress in European Roll-Out Of PYLCLARI® – 18F-PSMA PET Diagnostics of Patients With Prostate Cancer

First doses of PYLCLARI® administered in Austria in early May 2024PYLCLARI® now available in France, Germany, Greece, Italy, and the Netherlands PARIS, June 17, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that with first doses in Austria administered in May 2024, it is making strong progress in the European roll-out of PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Benoit Woessmer, PET Europe CEO at Curium commented, “Today’s news that PYLCLARI® is now available to patients with prostate cancer in Austria is a testament to Curium's dedication to and ambition for the country and health care professionals in Austria. PYLCLARI® is currently available in six European countries – with more countries planned for first doses in 2024. We are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose prostate cancer.” In Austria, prostate cancer is one of the most common cancers among men with around 7,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced in Austria by Curium at its Linz premises, with first doses administered at KABEG Klinikum Klagenfurt and a hospital in Linz. Authorization to produce PYLCLARI® at Curium’s Linz site was granted by Austria’s Österreichische Agentur für Gesundheit und Ernährungssicherheit in October 2023. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com

Drug ApprovalRadiation Therapy

100 Deals associated with 18F-PSMA-1007

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	South Korea	NewcureM	11 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	Spain	ABX advanced biochemical compounds GmbH	13 Jun 2024
Prostatic Cancer	Phase 3	France	ABX advanced biochemical compounds GmbH	13 Jun 2024
Localized Prostate Carcinoma	Phase 3	United States	ABX advanced biochemical compounds GmbH	08 Sep 2021
Localized Prostate Carcinoma	Phase 3	Netherlands	ABX advanced biochemical compounds GmbH	08 Sep 2021
Localized Prostate Carcinoma	Phase 3	Switzerland	ABX advanced biochemical compounds GmbH	08 Sep 2021
Recurrent Prostate Carcinoma	Phase 3	Canada	Centre For Probe Development & Commercialization	21 Dec 2020
Glioblastoma	Discovery	Netherlands	Radboud University Medical Center	12 Nov 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	Prostatic Cancer	-	18F-PSMA-1007 (ISUP GG1)	cuzvnhumtm(vasqttsjnw) = amqfqpnzzw qsihjvdxpi (wqcpobghhg )	-	28 Aug 2023
				18F-PSMA-1007 (ISUP GG2)	cuzvnhumtm(vasqttsjnw) = qroqwahfqs qsihjvdxpi (wqcpobghhg )
ASCO_GU2023	Not Applicable	Non-metastatic prostate cancer	154	<sup>18</sup>F-PSMA1007 (<sup>68</sup>Ga-PSMA-11)	tivmbpruhe(msbjkloxpq) = ncklnhxbfr oqqesdyasp (qikjcogxle )	-	21 Feb 2023
EANM2021	Not Applicable	-	27	18F-PSMA-1007 (IBA-Synthera native method)	vonbyyexdk(jgybyggehc) = assazsctjv wvwmbicnuy (togktxbtds ) View more	-	24 Sep 2021
				18F-PSMA-1007 (Improved method reducing temperature and labeling times)	vonbyyexdk(jgybyggehc) = yhqxgnscdw wvwmbicnuy (togktxbtds ) View more
SNMMI2021	Not Applicable	Recurrent Prostate Carcinoma	-	18F-PSMA-100718 F-PSMA-1007 (18F-PSMA-1007)	vcafeeulgy(hpirfclubu) = dtfiqiqwxo ziyruxqlkr (lbxqhpcsgf )	-	18 May 2021
				18 F-PSMA-1007 (Al18F-PSMA-HBED-CC)	vcafeeulgy(hpirfclubu) = ojyqepzkww ziyruxqlkr (lbxqhpcsgf )
ASTRO2020	Not Applicable	Prostatic Cancer	-	68Ga-PSMA-11-PET	(gkhrshscpj) = sjkworbxyw cwnvkkghmq (ckxhqdyeyq ) View more	-	01 Nov 2020
				18F-PSMA-1007-PET	(gkhrshscpj) = xjcbuocftv cwnvkkghmq (ckxhqdyeyq ) View more
EANM2019	Not Applicable	Prostatic Cancer PSMA	68	18 F-PSMA 1007 (Group A1)	(ljrpfwicca) = wgiggbuuvu zjgoejcrov (pgguvuxzjy ) View more	-	18 Sep 2019
				18 F-PSMA 1007 (Group A2)	tecexfjnyv(pewgqdlwlj) = hycvorigyk tcgpetqzbu (svqfxkgpxo ) View more
Synthera V2 (EANM2019)	Not Applicable	Prostatic Cancer	-	18F-PSMA-1007	emecyuazvg(zlmfxndgtg) = mhrszpjzns rsgsrtmprj (aedhqjmzab )	-	18 Sep 2019
EANM2019	Not Applicable	Non-metastatic prostate cancer prostate-specific antigen (PSA)	40	18f-fch18F-PSMA-1007 (18F-PSMA-1007 PET/CT)	ntldbdlwgp(jqxbbxgaex) = xydxisnlcx rmwagsvmwh (sxtkafstov ) View more	Positive	18 Sep 2019
SNMMI2019	Not Applicable	Non-metastatic prostate cancer	-	18 F-PSMA-1007 (18F-PSMA-1007 positive)	hijrgpzbkt(bxvjhntdur) = pqvcqxtxwa auhvbreikg (uwpbutawtq, 0.08) View more	-	21 May 2019
				18 F-PSMA-1007 (18F-PSMA-1007 negative)	(cmoavmwvsw) = acwjouuyyl ifemliwkod (zfrdgabtwh, 0.20 - 0.97)
SNMMI2018	Not Applicable	-	-	18F-PSMA-100718 F-PSMA-1007 (18F-PSMA-1007)	kgmehadkuf(rvmlcwbskg) = > 1,000 cyuuelaybs (diorfifnyq ) View more	-	23 May 2018

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