Last update 19 Jun 2024

18F-PSMA-1007

Last update 19 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms-

Target

PSMA

Mechanism

PSMA modulators(Prostate-specific membrane antigen modulators)

Therapeutic Areas

NeoplasmsUrogenital DiseasesOther Diseases

Active Indication

Localized Prostate CarcinomaRecurrent Prostate CarcinomaDiagnostic agents

Inactive Indication

Glioblastoma

Originator Organization

German Cancer Research Center

Active Organization

ABX advanced biochemical compounds GmbH

German Cancer Research Center

Inactive Organization

Radboud University Medical Center

Centre For Probe Development & Commercialization

McDougall Scientific Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Structure

Molecular FormulaC49H55FN8O16

InChIKeyRFFFFGRYVZESLB-CXODGJKXSA-N

CAS Registry2093321-19-6

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Gene Sequence

Sequence Code 527975753

Clinical Trials associated with 18F-PSMA-1007

NCT06122584 / Not yet 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 Date01 Jan 2024

Sponsor / Collaborator

ABX advanced biochemical compounds GmbH

NCT05712174 / RecruitingPhase 2IIT

A Phase II Study of Fluorine-18 (18F)-Labeled PSMA-1007 in Patients With Known or Suspected Metastatic Prostatic Carcinoma

A [18]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors.
The purpose of this study is to: 1) assess the clinical impact of a [18]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a [18]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of [18]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.

Start Date14 Sep 2023

Sponsor / Collaborator

AHS Cancer Control Alberta

NCT05520255 / RecruitingPhase 3IIT

18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:
The participant will be screened for adverse effects immediately post-injection
The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)
The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:
All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021)
Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

Start Date25 Jul 2023

Sponsor / Collaborator

University of Alberta

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

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

PURPOSE:

Multiparametric 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.

METHODS:

This 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.

RESULTS:

Overall, 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).

CONCLUSIONS:

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

BACKGROUND:

Several 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.

METHODS:

Our 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.

RESULTS:

In 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.

CONCLUSION:

Given 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.

01 May 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Unspecific¹⁸F-PSMA-1007 Bone Uptake Evaluated Through PSMA-11 PET, Bone Scanning, and MRI Triple Validation in Patients with Biochemical Recurrence of Prostate Cancer

Article

Author: Seifert, Robert ; Opitz, Marcel ; Barbato, Francesco ; Fendler, Wolfgang P ; Telli, Tugce ; Umutlu, Lale ; Hadaschik, Boris ; Berliner, Christoph ; Herrmann, Ken ; Stuschke, Martin ; Nader, Michael

¹⁸F-PSMA-1007 PET is used in the management of patients with prostate cancer. However, recent reports indicate a high rate of unspecific bone uptake (UBU) with ¹⁸F-PSMA-1007, which may lead to a false-positive diagnosis. UBU has not been evaluated thoroughly. Here, we evaluate the frequency of UBU and bone metastases separately for ¹⁸F-PSMA-1007 and ⁶⁸Ga-PSMA-11 in biochemical recurrence (interindividual comparison). Additionally, we investigate UBU seen in ¹⁸F-PSMA-1007 through follow-up examinations (intraindividual comparison) using ⁶⁸Ga-PSMA-11 PET, bone scintigraphy, and MRI. Methods: First, all patients (n = 383) who underwent ⁶⁸Ga-PSMA-11 PET between January 2020 and December 2020 and all patients (n = 409) who underwent ¹⁸F-PSMA-1007 PET between January 2020 and November 2021 due to biochemical recurrence were included for an interindividual comparison of bone metastases and UBU rate. In a second approach, we regarded all patients with UBU in ¹⁸F-PSMA-1007, characterized by focal bone uptake with an SUV_max > 4 and prostate-specific antigen (PSA) ≤ 5 ng/mL, who underwent additional ⁶⁸Ga-PSMA-11 PET (n = 17) (interindividual comparison). Of these, 12 patients also had bone scintigraphy and whole-body MRI within a 1- to 5-wk interval. Bone uptake seen on ¹⁸F-PSMA-1007 but not on any of the other 4 modalities (CT, MRI [n = 1], bone scanning, and ⁶⁸Ga-PSMA-11 PET) was recorded as false-positive. Results: Patients scanned with ¹⁸F-PSMA-1007 PET had a significantly higher rate of UBU than those scanned with ⁶⁸Ga-PSMA-11 (140 vs. 64; P < 0.001); however, the rate of bone metastases was not significantly different (72 vs. 64; P = 0.7). In the intraindividual comparison group, workup by CT, MRI, bone scanning, and ⁶⁸Ga-PSMA-11 PET resulted in a positive predictive value for ¹⁸F-PSMA-1007 focal bone uptake (mean SUV_max, 6.1 ± 2.9) per patient and per lesion of 8.3% and 3.6%, respectively. Conclusion: In patients with PSA ≤ 5 ng/mL and SUV > 4 at biochemical recurrence, most ¹⁸F-PSMA-1007 focal bone uptake is likely to be false-positive and therefore due to UBU. In the case of low clinical likelihood of metastatic disease, ¹⁸F-PSMA-1007 bone uptake without morphologic surrogate should be assessed carefully with regard to localization and clinical context. However, the rate of bone metastases was not higher with ¹⁸F-PSMA-1007 in the clinical routine, indicating that experienced reporting physicians adjust for UBU findings.

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

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

30 May 2024

·www.globenewswire.com

Curium Announces First Commercial Doses in France of Pylclari® – an Innovative 18F-Psma Pet Tracer Indicated in Patients With Prostate Cancer

PARIS, May 30, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that earlier this month patients in France received the first doses 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 Today’s news follows earlier announcements by Curium of the first doses for Greece in November 2023, and for 2024 first doses for Italy in February, for the Netherlands in March, and for Germany in May. Benoit Woessmer, PET Europe CEO at Curium commented, “We are extremely pleased with today’s news that PYLCLARI® is now available to patients with prostate cancer in France. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, the growing availability of PYLCLARI® in Europe is improving the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose and monitor prostate cancer – ultimately for the benefit of patients with prostate cancer.” In France, prostate cancer is one of the most common cancers among men with around 60,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced in France at Curium’s facilities in Bordeaux, Lyon, Nancy, Marseille, Paris, and Tours. 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

06 May 2024

·www.globenewswire.com

Curium Announces First Commercial Doses in Germany of PYLCLARI® – An Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer

PARIS, May 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that today in Munich and Nurnberg, Germany the first commercial doses of PYLCLARI® have been delivered. 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, “We are pleased with the growing availability of PYLCLARI® to more nuclear medicine physicians and their patients across Europe. With today’s announcement, we are extremely proud to be improving the choice of diagnostic modalities available to our customers in Germany – ultimately for the benefit of patients with prostate cancer.” In Germany, prostate cancer is the most common cancer among men with around 63,400 new cases diagnosed nationwide every year. Today’s announcement is part of the continued roll-out of PYLCLARI® across the European Union, which is now available for patients with prostate cancer in Greece, Italy, and the Netherlands. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat (18F) 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 Approval

100 Deals associated with 18F-PSMA-1007

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	US	ABX advanced biochemical compounds GmbH	08 Sep 2021
Localized Prostate Carcinoma	Phase 3	NL	ABX advanced biochemical compounds GmbH	08 Sep 2021
Localized Prostate Carcinoma	Phase 3	CH	ABX advanced biochemical compounds GmbH	08 Sep 2021
Recurrent Prostate Carcinoma	Phase 3	US	ABX advanced biochemical compounds GmbH	08 Sep 2021
Recurrent Prostate Carcinoma	Phase 3	NL	ABX advanced biochemical compounds GmbH	08 Sep 2021
Recurrent Prostate Carcinoma	Phase 3	CH	ABX advanced biochemical compounds GmbH	08 Sep 2021
Prostatic Cancer	Phase 3	FR	ABX advanced biochemical compounds GmbH	06 Mar 2019
Glioblastoma	Phase 2	NL	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


ASCO_GU2023	Not Applicable	Non-metastatic prostate cancer	154	<sup>18</sup>F-PSMA1007 (<sup>68</sup>Ga-PSMA-11)	mzxjfexbuw(yvqnzvushl) = gsbywgxpuz uzyblvvvzy (wiekjkyskw )	-	21 Feb 2023

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