PSMA-1007
A fluorine-18 PSMA scan agent that leaves the body mainly through the liver, not the bladder
PSMA-1007 is a radioactive imaging agent that binds PSMA, a protein on most prostate cancer cells, so a PET scan can show where the cancer is. It is authorised as Radelumin in Spain, Germany, France and seven other European countries and in Switzerland, but not in the US. Like every PET tracer it is a hospital diagnostic, injected once before a scan, and it is not something anyone can buy.
Used in human trials: 3.7 MBq/kg, Single injection, Intravenous (Study: phase I/IIa, healthy volunteers and prostate cancer (Japan)) Details ↓
Recommended Dosing
Used in human trials
There is no FDA label. A label from outside the US exists (see the regulatory status on this page) but was not read for this page: these are amounts given in published trials, not recommendations.
What is it?
In a radioligand scan, a patient is injected with a very small amount of a molecule designed to bind one target, with a radioactive atom attached so a camera can find it. For prostate cancer the target is usually prostate-specific membrane antigen (PSMA), a protein that most prostate cancer cells carry in large amounts. A positron emission tomography (PET) scanner detects the radiation and shows where the molecule has gathered, and a CT taken at the same visit places those spots in the anatomy. The result is a map of where the cancer has spread, which guides whether surgery or radiotherapy can still cure it and where to aim.
PSMA-1007 is one of these tracers, labelled with fluorine-18. Its developers chose it from several fluorine-18 candidates for its high labelling yield, strong tumour uptake and fast background clearance that bypasses the urine. Its distinguishing feature is where it goes after the scan. Most PSMA tracers leave through the kidneys and fill the bladder with radioactive urine, which can hide a recurrence beside it. PSMA-1007 is cleared mainly through the liver and bile; its Spanish product information records only about 2.4% of the activity in urine over six hours. The trade-off is a brighter liver.
Its regulatory status differs by country, so it is worth stating plainly. FDA has not approved it, and it is not in the European Medicines Agency's central register. It is authorised nationally as Radelumin, made by ABX: the Spanish medicines agency lists a first authorisation in May 2023, and the patient leaflet names ten countries in the European Economic Area (Austria, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Poland, Portugal and Spain). Switzerland authorised it on June 11, 2024. In each case it is a prescription radiopharmaceutical given only by nuclear medicine staff for a scan. It has no other use, and there is no product a person could buy.
The evidence for that authorisation came from a multicentre phase 3 trial. In 190 men whose cancer had returned after treatment, each scanned with both PSMA-1007 and fluorocholine in random order, an independent panel judged the PSMA-1007 scan correct in 82% against 65%, and decisions based on it helped patients more often. A second phase 3 trial of 186 men pointed the same way (84% against 69%). Pooled studies in recurrent disease put its detection rate near 81%, rising with PSA, and a 2026 meta-analysis of initial staging found it specific for lymph node spread (94%) but only moderately sensitive (42%), the same small-deposit problem every PSMA tracer has.
Head to head it performs much like other PSMA agents. Against gallium-68 PSMA-11 (gozetotide) in 50 men, overall stage agreed in 92%, PSMA-1007 saw more around the bladder and ureters, and the liver background hid one adrenal deposit. Against 18F-DCFPyL (piflufolastat) in 12 men, both found the same lesions. Before surgery it found pelvic node disease in 87% of node-positive men, against 45% for whole-body MRI and 26% for CT, and in the prostate it located significant cancer more often than fluciclovine, though fluciclovine lit up the few tumours PSMA-1007 missed.
Its known weakness is bone. Many scans show faint focal spots in the ribs and pelvis that turn out not to be cancer: in a four-centre review half of 348 patients had at least one, more often on digital scanners, and in men with recurrence and low PSA fewer than one in ten such spots proved to be metastases when checked with other imaging. Readers have learned to weigh these spots against the clinical picture. The Spanish product information sets the activity by body weight with a 450 MBq ceiling and puts the effective dose at 0.0191 mSv per MBq, about 5.3 mSv at the 280 MBq it suggests for a 70 kg adult.
Mechanism of Action
PSMA-1007 carries fluorine-18 to prostate-specific membrane antigen, so cancer that carries PSMA shows on a PET scan.
PSMA binding
A glutamate-urea motif binds PSMA on prostate cancer cells.
Positron imaging
Fluorine-18 emits positrons that the PET scanner detects.
Liver clearance
Elimination is mainly hepatobiliary; little reaches the urine, so the bladder stays relatively dark (Spanish SmPC 5.2).
Published Research
The studies behind PSMA-1007, read from their PubMed abstracts. All gave the fluorine-18 tracer to people, mostly men with prostate cancer.
Phase 3 against fluorocholine
In 190 men with suspected recurrence, scanned with both tracers in random order, correct detection rates were 0.82 against 0.65 counting equivocal findings as positive, and 0.77 against 0.57 counting them as negative; PSMA-1007 contributed more to beneficial decisions.
Greek phase 3 against choline
In 186 men with biochemical recurrence scanned with both tracers within 8 days, the correct detection rate was 84% against 69% for 18F-choline; at PSA of 1 ng/mL or less it was 61.8% against 39.5%.
Meta-analysis in recurrent disease
Across ten studies in the quantitative analysis (from 15 articles and 853 patients), the pooled detection rate in biochemically recurrent prostate cancer was 81.3%, with heterogeneity, and it depended on PSA.
Meta-analysis of initial staging
In a review of 19 studies checked against pathology, pooled patient-level sensitivity and specificity were 42% and 94% for lymph node metastases (5 studies) and 54% and 92% for spread outside the prostate capsule (3 studies).
Against gallium-68 PSMA-11
In 50 men scanned with both within four weeks, overall stage agreed in 92%; PSMA-1007 had higher uptake in lesions and most normal organs except the bladder, upstaged more local and nodal disease, but gave more equivocal bone findings and its liver background obscured an adrenal metastasis.
Against PSMA-11 for cancer inside the prostate
In 50 men checked against prostatectomy pathology, fluorine-18 PSMA-1007 and gallium-68 PSMA-11 found clinically significant cancer in 98% and 100%, a difference that was not significant; both were more sensitive than MRI.
Against 18F-DCFPyL
Twelve men received about 250 MBq of each tracer 48 hours apart; both found the same lesions with similar uptake, PSMA-1007 showing more background in liver, spleen and salivary glands and less in kidneys and bladder.
Node staging against whole-body MRI and CT
In 79 men with unfavourable intermediate- or high-risk cancer, PSMA-1007 detected pelvic node metastases in 27 of 31 node-positive men (87%), against 45% with whole-body MRI and 26% with CT, with specificity of 98%.
TRACER: against fluciclovine inside the prostate
In 57 men scanned with both before prostatectomy, lesion-level sensitivity for clinically significant cancer was 86.8% with PSMA-1007 against 73.5% with fluciclovine, yet fluciclovine showed all five index tumours that did not take up PSMA-1007.
Against MRI for local staging
In 19 men with 39 tumour foci at prostatectomy, PET found 94.7% of index lesions against 74% to 84% for MRI, but MRI was better at judging spread through the capsule.
Unspecific bone spots, four centres
Focal mild bone uptake with no clear cause appeared in 179 of 348 patients (51.4%), mostly in ribs and pelvis and more often on digital PET/CT; of 65 followed up, 14% proved malignant, 43% benign and 43% stayed unclear.
Unspecific bone spots checked three ways
In men with recurrence, PSA of 5 ng/mL or less and focal bone uptake above SUV 4, checking with PSMA-11 PET, bone scan and MRI gave PSMA-1007 bone spots a positive predictive value of 8.3% per patient; the overall rate of reported bone metastases matched PSMA-11.
First biodistribution and dosimetry
In three volunteers and ten high-risk patients, the effective dose was about 4.4 to 5.5 mSv per 200 to 250 MBq scan, urinary clearance was low, and in eight men who had surgery the scan found 18 of 19 pelvic node metastases, some as small as 1 mm.
Phase I/IIa in Japan
Three healthy volunteers and ten patients received a single 3.7 MBq/kg dose; there were no serious or drug-related adverse events, and in seven untreated patients sensitivity was 80% and specificity 96.5% at 60 minutes.
Dosing Data
No US label exists. These are the activities given in published human studies; national European product information sets the activity by body weight.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
What a Buyer Needs to Know
What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.
What is sold
Unknown: we hold no regulator's label that says in what form PSMA-1007 is supplied. It is a radioactive drug: the next part says where it is prepared and given.
Mixing a vial: a worked example
Nothing to mix at home, and no syringe units to work out: PSMA-1007 is a radioactive drug, prepared and given in nuclear-medicine departments, and its dose is an amount of radioactivity (MBq or GBq), not a weight.
This page's dosing note: “PSMA-1007 is dosed by radioactivity, scaled to body weight and measured by nuclear medicine staff; no reconstitution maths applies.”
Source: this page's own note in Dosing Data below; the amount of each dose row in Dosing Data below.
Storage before and after mixing
Unknown: no label on file says how PSMA-1007 is stored. It is a radioactive drug held by the nuclear-medicine department that prepares and gives it (see the part above); the home rules for a mixed vial in the mixing guide do not apply to it.
How it is taken
As it was given in human studies: Intravenous (Single injection; Study: phase I/IIa, healthy volunteers and prostate cancer (Japan)).
Source: Used in human trials: the route and frequency of each row in Dosing Data below.
What to expect, and when
How long it stays in the body: not established by a measurement cited on this entry.
How long the doses were given: Study: phase I/IIa, healthy volunteers and prostate cancer (Japan): Imaging from 60 minutes; Study: intra-individual comparison with 18F-DCFPyL, 12 men: Imaging 2 hours after injection.
When effects appear: unknown; no source on this page gives a time to effect for PSMA-1007. Results reported in the studies are under Published Research.
Source: Used in human trials, the duration of each row in Dosing Data below.
Side effects, and when to stop or get help
From the Side Effects section: No serious or drug-related adverse events in the Japanese phase I/IIa study; Radiation exposure: about 4.4 to 5.5 mSv per 200 to 250 MBq scan in the first dosimetry study; False-positive bone spots: focal uptake without cancer in about half of patients in one multicentre review. Full list and cautions ↓
When to stop or get help: unknown; no label or trial on file sets rules for stopping PSMA-1007. Treat a severe or unexpected reaction as a reason to stop and see a doctor.
Source: the Side Effects section below (“From the studies above”).
Interactions
Unknown: a PubMed search for human interaction studies of PSMA-1007 (reviewed 2026-10-28) found none. Unknown is not the same as safe to combine.
Every peptide's record, with its source: the interaction matrix.
Checking what you bought
Unknown: no published independent test of PSMA-1007 products is in our lab-results database yet, so how products sold under this name measure up is not known.
To read a certificate of analysis, paste it into the COA decoder. Trust & Verification explains what independent testing can and cannot show.
Legal status
US: Not FDA Approved (Not approved by FDA (no Drugs@FDA record, searched October 29, 2026) and not in the EMA medicines list). Elsewhere: approved in Ten EEA countries by national authorisation (Radelumin, ABX; Spain first, May 2023) and Switzerland (Swissmedic, June 11, 2024). Sport: Unsettled (S0 may apply).
Country by country ↓ · Regulatory tracker
Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.
Side Effects & Contraindications
Reported Side Effects
From the studies above.
Contraindications & Cautions
From the Spanish product information for Radelumin (AEMPS CIMA, first authorised May 2023) and the studies above.
Legal Status
PSMA-1007 is authorised in some European countries as Radelumin and is investigational in the US.
Frequently Asked Questions
?What is a radioligand PET scan?
A test in which a tiny amount of a molecule that binds one target is injected with a radioactive atom attached, and a PET scanner shows where it collects. For prostate cancer the target is PSMA, so the scan shows where cancer cells are.
?Is PSMA-1007 approved?
Not in the US and not through the EU's central procedure. It is authorised nationally as Radelumin in ten European Economic Area countries, including Germany, France, Italy and Spain, and in Switzerland.
?Can I buy it?
No. It is a radioactive prescription diagnostic made on the day of use and injected by nuclear medicine staff. It has no use outside a scan, and the site names no seller.
?Why does liver clearance matter?
Most PSMA tracers pass into the urine, so the bladder shines and can hide a recurrence next to it. PSMA-1007 leaves mainly through the liver, which keeps the bladder quiet but makes the liver brighter.
?What are its pitfalls?
Faint spots in bone that are not cancer are common, especially on digital scanners, and the bright liver can hide small deposits there or in the adrenal glands.
References
- [other] Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA: Radelumin 2000 MBq/mL solución inyectable (ABX advanced biochemical compounds), summary of product characteristics (first authorisation May 2023; sections 4.1, 4.2, 5.2 and 11) and patient leaflet (revised October 2025; list of EEA member states). No US label: not on DailyMed, as it is not FDA-approved. Read October 29, 2026.
- [other] Swissmedic, Radelumin (active substance [18F]PSMA-1007), authorised June 11, 2024; Swiss Public Assessment Report summary (study ABX-CT-301, 190 participants). Read October 29, 2026.
- [other] European Medicines Agency, medicines list (downloaded October 3, 2026; searched October 29, 2026): no record for PSMA-1007. No Drugs@FDA record (openFDA, searched October 29, 2026).
- [registry] ClinicalTrials.gov API v2, read October 28, 2026: NCT04733768 (phase 2, biochemically recurrent or high-risk prostate cancer, completed).
- [clinical-trial] Olivier P, et al. "Phase III Study of (18)F-PSMA-1007 Versus (18)F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study." J Nucl Med, 2023;64(4):579-585. PMID: 36418170.
- [clinical-trial] Panagiotidis E, et al. "Comparison of 18F-PSMA-1007 and 18F-Choline PET/CT in prostate cancer patients with biochemical recurrence: a phase 3, prospective, multicenter, randomized study." Nucl Med Commun, 2023;44(12):1126-1134. PMID: 37779440.
- [review] Ferrari M, et al. "(18)F-PSMA-1007 PET in Biochemical Recurrent Prostate Cancer: An Updated Meta-Analysis." Contrast Media Mol Imaging, 2021;2021:3502389. PMID: 35002568.
- [review] Rahbar K, et al. "Efficacy of [(18)F]PSMA-1007 PET/CT in Primary Staging of Prostate Carcinoma: A Systematic Review and Metaanalysis." J Nucl Med, 2026;67(1):85-91. PMID: 41130789.
- [pubmed] Pattison DA, et al. "Prospective intra-individual blinded comparison of [(18)F]PSMA-1007 and [(68) Ga]Ga-PSMA-11 PET/CT imaging in patients with confirmed prostate cancer." Eur J Nucl Med Mol Imaging, 2022;49(2):763-776. PMID: 34383089.
- [pubmed] Gossili F, et al. "Head-to-head comparison of [¹⁸F]F-PSMA-1007 PET/CT and [⁶⁸Ga]Ga-PSMA-11 PET/CT for intraprostatic tumour detection and localisation using histopathology as reference: A prospective single-centre diagnostic accuracy study." Eur J Nucl Med Mol Imaging, 2026. PMID: 42762314.
- [clinical-trial] Giesel FL, et al. "Intraindividual Comparison of (18)F-PSMA-1007 and (18)F-DCFPyL PET/CT in the Prospective Evaluation of Patients with Newly Diagnosed Prostate Carcinoma: A Pilot Study." J Nucl Med, 2018;59(7):1076-1080. PMID: 29269569.
- [pubmed] Malaspina S, et al. "Prospective comparison of (18)F-PSMA-1007 PET/CT, whole-body MRI and CT in primary nodal staging of unfavourable intermediate- and high-risk prostate cancer." Eur J Nucl Med Mol Imaging, 2021;48(9):2951-2959. PMID: 33715033.
- [pubmed] Hoekstra RJ, et al. "Prospective Histopathologic Comparison Between [(18)F]PSMA-1007 PET/CT and [(18)F]Fluciclovine PET/CT of Intraprostatic Tumor Detection: The TRACER Study." J Nucl Med, 2026;67(1):79-84. PMID: 41233148.
- [clinical-trial] Kivikallio A, et al. "Prospective comparison of (18)F-PSMA-1007 PET/CT and MRI with histopathology as the reference standard for intraprostatic tumour detection and T-staging of high-risk prostate cancer." Eur J Nucl Med Mol Imaging, 2025;52(10):3709-3719. PMID: 40159542.
- [pubmed] Grünig H, et al. "Focal unspecific bone uptake on [(18)F]-PSMA-1007 PET: a multicenter retrospective evaluation of the distribution, frequency, and quantitative parameters of a potential pitfall in prostate cancer imaging." Eur J Nucl Med Mol Imaging, 2021;48(13):4483-4494. PMID: 34120201.
- [pubmed] Seifert R, et al. "Unspecific (18)F-PSMA-1007 Bone Uptake Evaluated Through PSMA-11 PET, Bone Scanning, and MRI Triple Validation in Patients with Biochemical Recurrence of Prostate Cancer." J Nucl Med, 2023;64(5):738-743. PMID: 36460340.
- [clinical-trial] Giesel FL, et al. "F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients." Eur J Nucl Med Mol Imaging, 2017;44(4):678-688. PMID: 27889802.
- [pubmed] Tateishi U, et al. "Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients." Jpn J Clin Oncol, 2024;54(3):282-291. PMID: 38066703.
Sources & Citations
Studies were read from their PubMed abstracts; national authorisations from the Spanish AEMPS (CIMA) product information and Swissmedic, read October 29, 2026. The stub's searches (October 28, 2026) found 498 PubMed records and 38 ClinicalTrials.gov studies for PSMA-1007, and no Drugs@FDA or EMA record.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.