Tracer library / [68Ga]Ga-PSMA-11
[68Ga]Ga-PSMA-11
Also written as [68Ga]Ga-PSMA-11; [68Ga]Ga-PSMA-HBED-CC; [68Ga]Ga-PSMA11; [68Ga]PSMA-11; [68Ga]PSMA-HBED-CC; [Ga-68]Ga-PSMA-11; [Ga-68]Ga-PSMA-HBED-CC
- Radionuclide
- Ga-68 t½ 67.7 min
- Modality
- PET
- Production route
- Generator / Cyclotron liquid target
- Stage
- Approved
- Syntheses indexed
- 56
What it is
- Compound class
- Small molecule (urea-based)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA / glutamate carboxypeptidase II) PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Clinical application
- Prostate cancer staging and biochemical recurrence PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Theranostic pair
- [177Lu]Lu-PSMA-617
Regulatory status
- FDA
- Yes — 2020; gallium Ga 68 gozetotide (NDA 212642 UCLA / NDA 212643 UCSF); commercial kits Illuccix (Telix, 2021), Locametz (Novartis, 2022), Gozellix (Telix, 2025) Drugs@FDA, NDA 212642 & 212643, approved 2020-12-01 (kits NDA 214032 / 215841 / 219592) — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=gozetotide
- EMA (centralised)
- Yes — 2022; Locametz (gozetotide); Novartis Europharm Limited; EMEA/H/C/005488 EMA medicines register, EPAR Locametz, marketing authorisation issued 2022-12-09 — https://www.ema.europa.eu/en/medicines/human/EPAR/locametz
- Other approvals
- —
- Brand names
- Illuccix; Locametz; Gozellix (US, FDA); Locametz (EU, EMA)
Clinical use
- Typical injected activity
- ~150-200 MBq (e.g. 182 +/- 47 MBq); ~1.8-2.2 MBq/kg per EANM/SNMMI guideline PMID 38761312 / DOI 10.1007/s12149-024-01939-z; PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Uptake time
- 50-100 min post-injection (typically ~60 min) PMID 28283702 / DOI 10.1007/s00259-017-3670-z
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| GAIA V2 Elysia-Raytest | vendor cassette | none | 89.55 ± 5.49 | >99% | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem Generators elution was performed using the GAIA® V2 module (Elysia-Raytest, Germany) controlled via the dedicated software (GAIA Control, Elysia-Raytest, Germany). - after process optimization, routine RCY improved to 89.55 ± 5.49% |
| Manual synthesis | fixed tubing | none | 88.41 ± 4.72 | 99.59% ± 0.35% by TLC and 98.75% ± 0.31% by HPLC | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem 68Ga eluates were used without elution processing, after elution of either one or two GalliAd® generators. - RCY (%) (mean value) 76.80 ± 5.4488.41 ± 4.72 |
| GAIA V2 Elysia-Raytest | vendor cassette | none | 70.46 ± 2.64 | 99.93 ± 0.06% by HPLC and 99.74 ± 0.27% by iTLC | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem Two GalliaPharm® generators were eluted using an automated fractionation method. 1.7 mL of 0.1 M HCl from the more recently installed generator and 0.7 mL from the older generator were collected, for a total of 2.4 mL per aliquot. - The RCY for the three validation batches was 70.46 ± 2.64%, and 66.31 ± 6.78% in routine production |
| Manual synthesis | fixed tubing | none | 78.79 ± 4.60 | 95.84% ± 4.94% by TLC and 93.72% ± 4.39% by HPLC | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem Two GalliAd® generators were manually eluted in sequence (1.1 mL of 0.1 M HCl each) and combined directly in the aliquot vial. - RCY (%) (mean value) 70.46 ± 2.6478.79 ± 4.60 |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | 91-102% decay-corrected | 98.0-99.6% | Locametz® kit (gozetotide, PSMA-11) Novartis | 38632189 2024 EJNMMI Radiopharm Chem a Scintomics® GRP 3V module (Scintomics® GmbH, Fürstenfeldbruck, Germany) - Radiolabelling with one and two generator(s) resulted in a radiochemical yield of 91–102% and 96–101% after preparation, respectively. |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | 96-101% decay-corrected | 98.4-99.3% | Locametz® kit (gozetotide, PSMA-11) Novartis | 38632189 2024 EJNMMI Radiopharm Chem a Scintomics® GRP 3V module (Scintomics® GmbH, Fürstenfeldbruck, Germany) - Radiolabelling with one and two generator(s) resulted in a radiochemical yield of 91–102% and 96–101% after preparation, respectively. |
| GAIA Elysia-Raytest | vendor cassette | SPE | 68.3% ± 2.1% | 97.72% ± 0.04% (TLC); 91.24% to 94.81% (HPLC) | PSMA-11 ABX | 38424422 2024 Curr Radiopharm A GAIA® synthesis module and a GALLIAD® generator were used. - These three validation batches were produced with a mean RCY of 68.3% ± 2.1%. |
| In-house / custom built | custom manifold | SPE | 83 ± 11% decay-corrected | >99% | PSMA-11 precursor ABX | 39407503 2024 Molecules Synthesis of [68Ga]Ga-PSMA-11 using concentrated Ga-68 was conducted on a Teflon-coated silicon chip patterned with a circle hydrophilic reaction site, operated on a temperature-controlled heating platform - the final product was obtained with a high radiochemical yield (RCY) of 83 ± 11% (n = 3) |
| miniAllinOne Trasis | vendor cassette | SPE | 45.8 ± 29.4 | 71.8% | PSMA-11 Iason GmbH | 38004410 2023 Pharmaceuticals (Basel) radiosynthesis was performed on MiniAIO® synthesis module (Trasis®, Ans, Belgium) - The mean labeling yields for double elution with prepurification were 45.8 ± 29.4 (mean ± standard deviation) |
| miniAllinOne Trasis | vendor cassette | SPE | 97.5 ± 1.9 | — | PSMA-11 Iason GmbH | 38004410 2023 Pharmaceuticals (Basel) radiosynthesis was performed on MiniAIO® synthesis module (Trasis®, Ans, Belgium) - The mean labeling yields for the fractionated double elution were 97.5 ± 1.9 (mean ± standard deviation) |
| GAIA V2 Elysia-Raytest | vendor cassette | SPE | 81 ± 3% not corrected | >95% | PSMA-11 Advanced Biochemical Compounds, ABX, Germany | 35337140 2022 Pharmaceuticals (Basel) Synthesis was performed on a fully automated radiosynthesis cassette module (GAIA V2™, Elysia-Raytest, Straubenhard, Germany) - a high (81 ± 3% non-decay corrected) and highly reproducible RCY |
| iQS-TS | — | SPE | 86.82% ± 2.57% | >99% | PSMA-11 | 35177423 2022 J Nucl Med An iQS-TS automated module was used for all radiolabeling steps - yield rates of 88.07% ± 1.26% and 86.82% ± 2.57%, respectively |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | >85% not corrected | 99.06 ± 0.10% | Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11) ABX | 33918987 2021 Pharmaceuticals (Basel) an automated Modular-Lab PharmTracer synthesis module (Eckert and Ziegler—Berlin, Germany) for routine production - Radiolabeling yields of >85% were obtained. |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | SPE | 76 ± 3 decay-corrected | 99.9 ± 0.2 | PSMA-11 ABX | 33067810 2021 J Labelled Comp Radiopharm iPHASE MultiSyn module - Formulated and sterile radiopharmaceuticals were obtained in 76 ± 3% (n = 20) and 91 ± 4% (n = 15) radiochemical yields after 17 and 20 min, respectively. |
| GAIA V2 Elysia-Raytest | vendor cassette | — | 91% vs 43% not corrected | — | PSMA-11 Advanced Biochemical Compounds, ABX, Germany | 33761040 2021 EJNMMI Radiopharm Chem loaded in an automated radiosynthesis module (GAIA V2™, Elysia-Raytest, Germany), by using disposable reagents assembled in a disposable sterile cassette. - a decrease in the percentage of radiolabeling yield non-decay corrected (n.d.c.) at end of synthesis (EOS) (i.e., 91% vs 43%) |
| FASTlab Developer GE HealthCare | vendor cassette | SPE | — decay-corrected | 99.4 | PSMA-11 precursor | 33180205 2020 EJNMMI Radiopharm Chem GE FASTlab Developer platform |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | — | — | PSMA-11 ABX | 32939194 2020 World J Nucl Med the Scintomics GRP module was used for automated synthesis |
| Scintomics GRP / GRP-3V Scintomics | — | SPE | — | — | PSMA-11 ABX | 32410136 2020 EJNMMI Radiopharm Chem The syntheses were performed using a GRP® synthesis module from Scintomics (Fürstenfeldbruck, Germany) with the cationic concentration protocol provided by Scintomics. |
| ITG labeling module ITG (Isotope Technologies Garching) | — | SPE | >95% | 99.6 ± 0.1% | HBED-CC-Lys-CO-Glu…HBED-CC-Lys-CO-Glu (Glu-urea-Lys(Ahx)-HBED-CC) | 29853810 2018 Contrast Media Mol Imaging 68Ga-PSMA-11 was semiautomatically synthesized using the labeling module (iTG) as shown in Supplemental Figure 1. - The radiochemical yield of 68Ga-PSMA-11 from the synthesis module was more than 95%. |
| iQS-TS ITG (Isotope Technologies Garching) | vendor cassette | SPE | 63.4 | 99.3 | PSMA-11 | 34658552 2021 Indian J Nucl Med Hot cell to house 68Ga iQS-TS Synthesis module, ITG, Germany - 68Ga PSMA-11 13 63.4±2.2 4-6 99.3±0.2 |
| GAIA V2 Elysia-Raytest | vendor cassette | none | 89.55 ± 5.49% | > 99% | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem Generators elution was performed using the GAIA® V2 module (Elysia-Raytest, Germany) - after process optimization, routine RCY improved to 89.55 ± 5.49% |
| Kit-based preparation | vendor cassette | none | 80.07 ± 1.71% | 99.99% ± 0.01% | PSMA-11 Novartis | 42251618 2026 EJNMMI Radiopharm Chem lyophilized PSMA-11 kits (Locametz®, Novartis, France) were reconstituted with 1 mL of water for injection - RCY (%) (mean value) 83.53 ± 6.16 80.07 ± 1.71 |
| Scintomics GRP / GRP-3V | vendor cassette | SPE | 62 | >99% for 68Ga-PSMA | PSMA-HBED-CC | 41824275 2026 EJNMMI Radiopharm Chem an automated synthesis module (Scintomics GRP®, Fürstenfeldbruck, Germany) - assuming a reference radiolabelling yield of 62% |
| Modular-Lab Standard Eckert & Ziegler | — | — | 94.31±6.18 | >95% | PSMA-11 | 41370506 2025 Einstein (Sao Paulo) the standardization of the automated synthesis process using a Modular-Lab Standard module (Eckert & Ziegler) - Labeling Yield (%)89.03±3.7894.31±6.18 |
| Manual synthesis | — | none | — | >97% | PSMA-11 trifluoroacetate salt (precursor A)…PSMA-11 trifluoroacetate salt (precursor A) / PSMA-11/Mannitol (precursor B) ABX | 40941986 2025 Molecules PSMA-11 precursor and 5 mg of ascorbic acid dissolved in 1 mL of acetate buffer were added to a vial containing about 5 mL of gallium-68 chloride in 0.1 M hydrochloric acid. The vial was placed in a heating block preheated to 95 °C and incubated for 5 min. - The labeling of [68Ga]Ga-PSMA-11 was performed using activities that yielded final product activities in the range of 1090–3095 MBq, with most values exceeding 2000 MBq. |
| Kit-based preparation POLATOM | vendor cassette | none | — | >97% | PSMA-11 kit for radiolabeling POLATOM | 40941986 2025 Molecules The labeling procedure of the precursor C was performed according to the standard kit manufacturer’s instruction. - The labeling of [68Ga]Ga-PSMA-11 was performed using activities that yielded final product activities in the range of 1090–3095 MBq, with most values exceeding 2000 MBq. |
| Manual synthesis | — | — | — | >95% | PSMA-11 ABX | 40147849 2025 J Nucl Med 68Ga radiolabeling of PSMA-11 was done by eluting a 68Ge/68Ga generator (ITM Medical Isotopes GmbH) with 4 mL of 0.05 M hydrochloric acid into a 1-mL sodium acetate buffer containing 35 µg of PSMA-11. |
| Kit-based preparation | — | HPLC | >97% | — | PSMA-11 ABX | 40135799 2025 J Med Chem PSMA-11 (4–8 μg ≙ 4.2–8.4 nmol; ABX advanced biochemical compounds GmbH, Radeberg, Germany) was labeled with 68GaCl3 (150 to 250 MBq) in 400 μL ammonium acetate (2 M) and HCl at pH 4.5. - The radiochemical yield for [68Ga]Ga-PSMA-11 was >97% |
| Kit-based preparation Novartis | vendor cassette | — | 95.03% not corrected | 98.41 ± 0.47% | PSMA-11 Novartis | 39692998 2024 EJNMMI Radiopharm Chem Cold kit labeling is expected to facilitate global access to 68Ga-labeled radiopharmaceuticals including [68Ga]Ga-PSMA-11 - Using the Locametz kits, the overall production success rate was 95.03% (172/181). |
| Kit-based preparation Telix Pharmaceuticals | vendor cassette | — | 99.22% not corrected | 97.81 ± 0.71% | PSMA-11 Telix Pharmaceuticals | 39692998 2024 EJNMMI Radiopharm Chem Cold kit labeling is expected to facilitate global access to 68Ga-labeled radiopharmaceuticals including [68Ga]Ga-PSMA-11 - Using Illuccix kits (n = 256), the overall production success rate was 99.22% (254/256). |
| FASTlab 2 GE HealthCare | custom manifold | none | — | 98.83 ± 0.19 | HBED-CC-PSMA-11 ABX | 39598846 2024 Molecules Automated labeling of the precursor was accomplished using a FASTLab 2 synthesizer. |
| In-house / custom built | custom manifold | SPE | 83 ± 11% decay-corrected | >99% | PSMA-11 precursor ABX | 39407503 2024 Molecules microdroplet synthesis of [68Ga]Ga-PSMA-11 - the final product was obtained with a high radiochemical yield (RCY) of 83 ± 11% (n = 3) |
| GAIA Elysia-Raytest | vendor cassette | SPE | 68.3% ± 2.1% | 97.72% ± 0.04% | PSMA-11 ABX | 38424422 2024 Curr Radiopharm A GAIA® synthesis module and a GALLIAD® generator were used. - These three validation batches were produced with a mean RCY of 68.3% ± 2.1%. |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | — | — | PSMA ABX | 35889351 2022 Molecules the automated synthesis module Scintomics GRPTM (Scintomics GmbH, Fürstenfeldbruck, Germany) |
| Manual synthesis | — | — | — | — | PSMA-11 ABX | 34370181 2022 Mol Imaging Biol [68Ga]Ga-PSMA-11 and [18F]F-JK-PSMA-7 were labeled according to standard protocols, which have been published elsewhere [18]. |
| Kit-based preparation n/a (commercial cold kit, various vendors) | — | — | 1.52 GBq | >95 % | [68Ga]GaCl3 | 38447298 2024 Nucl Med Biol used to label 1 NetSpot and 2 Illuccix kits simultaneously - [68Ga]GaCl3 was added to 2.5 mL of buffer which gave 1.52 GBq of [68Ga]Ga-PSMA-11 |
| Kit-based preparation n/a (commercial cold kit, various vendors) | — | — | — | — | gallium (68 Ga) chloride | 35869898 2022 J Labelled Comp Radiopharm Radiolabeling success, suitability of quality control parameters, and in vitro stability of [68 Ga]Ga-PSMA11 radiopharmaceutical performed with ANMI kit were examined. |
| Manual synthesis n/a | — | — | — | — | gallium (68 Ga) chloride | 35869898 2022 J Labelled Comp Radiopharm Direct cold labeling of PSMA11 ligand with sodium bicarbonate buffer was examined. |
| — | — | HPLC | 68.71 | 98 ± 0.22% | PSMA-HBED-CC | 35190517 2022 Nucl Med Commun |
| FASTlab GE HealthCare | — | — | 51.2% | — | 68Zn | 34763197 2022 Nucl Med Biol using a single FASTlab time-list - a radiochemical yield of 51.2% was produced in 63 min |
| Kit-based preparation n/a (commercial cold kit, various vendors) | — | — | — | >99% | 68Zn | 34763197 2022 Nucl Med Biol by kit labeling (N = 1) |
| Kit-based preparation n/a (commercial cold kit, various vendors) | — | — | — | — | PSMA-11 | 32865290 2020 J Labelled Comp Radiopharm Cold-kits or automated synthesis are viable options for standardized methods |
| miniAllinOne Trasis | — | — | — | — | PSMA-HBED-CC | 32374450 2020 J Labelled Comp Radiopharm using the Trasis miniAllinOne radiosynthesizer |
| miniAllinOne Trasis | — | SPE | — | >99% | PSMA-11 | 32796487 2020 Nucl Med Commun The radiosynthesis of [Ga]Ga PSMA-11 was performed using a Trasis MiniAio synthesizer |
| In-house / custom built Laboratory | — | — | 70% | >99% | — | 32632739 2020 Mol Imaging Biol a microfluidic chip was assembled in polydimethylsiloxane (PDMS), combining all components of tracer production in an integrated, compact, and easily utilized platform - with an average radiochemical yield of 70 % |
| Modular-Lab (model not stated) Eckert & Ziegler | — | — | 84.2 ± 6.3% | >95% | PSMA-HBED-CC | 32796488 2020 Nucl Med Commun previously used Modular-Lab module - Automated module-involved synthesis of [Ga]Ga-PSMA-HBED- CC resulted in a radiochemical yield of 84.2 ± 6.3% |
| Kit-based preparation n/a (commercial cold kit, various vendors) | — | — | >98% | >95% | PSMA-HBED-CC | 32796488 2020 Nucl Med Commun For labeling with the lyophilized cold kit isoPROtrace-11, 2.5 ml 0.1 M HCl of the middle Ga-68 elution fraction were added to the kit - The room temperature cold kit gave a radiochemical yield of >98% |
| TRACERlab FX FN GE HealthCare | — | — | 77% ± 2% | >97% | PSMA-11 | 30672007 2019 J Labelled Comp Radiopharm Automated production of [68 Ga]Ga-DOTANOC and [68 Ga]Ga-PSMA-11 using a TRACERlab FXFN synthesis module. - Activity yields were 77% ± 2% for [68 Ga]Ga-PSMA-11 |
| — | — | none | 98% | 98% | PSMAHBED | 28082433 2017 J Nucl Med |
| — | — | — | 84 ± 6% | >98% | — | 28950199 2017 Appl Radiat Isot |
| Manual synthesis n/a | — | — | — | >95% | — | 27907840 2017 Nucl Med Biol without use of any synthesis module |
| Manual synthesis n/a | — | SPE | 93.19%±3.76% | >99% | PSMA-11 ligand | 27231953 2016 Nucl Med Biol using (68)Ge/(68)Ga generator and a manual synthesis module, both supplied by Isotope Technologies Garching (ITG), Germany - The radiochemical yields obtained were consistently high, 93.19%±3.76% |
| — | — | SPE | 49 ± 1.2 % decay-corrected | ≥98 % | PSMA-HBED (Glu-NH-CO-NH-Lys(Ahx)-HBED-CC) | 25869080 2015 Mol Imaging Biol |
| GAIA Elysia-Raytest | — | — | — | — | PSMA-11 | 31845408 2020 J Labelled Comp Radiopharm utilizing a cassette module (GAIA; Elysia-Raytest; Germany) with a manual setup |
| Manual synthesis n/a | — | — | — | — | PSMA-11 | 31845408 2020 J Labelled Comp Radiopharm manual setup for routine clinical production |
| — | — | — | >80% | >98% | PSMA-HBED-CC | 27103024 2016 J Nucl Med the generator system is contained within the fluidic labeling module - greater than 80% radiochemical yield |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- Pharmacokinetics and dosimetry of [177Lu]Lu-PSMA-617 and [68Ga]Ga-PSMA-11 in Japanese patients with PSMA-positive mCRPC.2025 · Ann Nucl Med · Prospective, multicentre · Phase II
- PSMA PET/CT in biochemical recurrence of prostate cancer with PSA levels ≤ 0.2 ng/mL: a German multicenter analysis of conventional PSMA tracers, including [68Ga]Ga-PSMA-11, [68Ga]Ga-PSMA I&T, and [18F]PSMA-1007.2025 · Eur J Nucl Med Mol Imaging · Multicentre
- Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial.2021 · JAMA Oncol · Prospective, multicentre · Phase III
- [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial.2021 · Lancet · Multicentre · Phase II
- TheraP: a randomized phase 2 trial of 177 Lu-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603).2019 · BJU Int · Multicentre · Phase II
- PSMA-targeted PET imaging in patients with metastatic triple-negative breast cancer: results of the prospective PRISMA trial.2026 · Eur J Nucl Med Mol Imaging · Prospective
- First-in-Human PET Imaging of Prostate Cancer Using [68Ga]Ga-AZ-093 and Its Nitroimidazole-Conjugated Derivative [68Ga]Ga-AZ-NI-093.2026 · J Nucl Med · Prospective
- PSMA radioligand uptake correlates with PSMA expression in high-grade glioma and brain metastasis: insights from a prospective PET-MRI guided multiregional biopsy study.2025 · Eur J Nucl Med Mol Imaging · Prospective
- Dual targeting PET tracer [68Ga]Ga-PSFA-01 in patients with prostate cancers: A pilot exploratory study.2025 · Theranostics · Prospective
- Comparison of Posttherapy 4- and 24-Hour [177Lu]Lu-PSMA SPECT/CT and Pretherapy PSMA PET/CT in Assessment of Disease in Men with Metastatic Castration-Resistant Prostate Cancer.2024 · J Nucl Med · Prospective
Show all 68 clinical studies
- Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA PET/CT Radioligand Infusions in Primary Prostatic Adenocarcinoma.2024 · Radiology · Prospective
- Change in total lesion PSMA (TLP) during [177Lu]Lu-PSMA-617 radioligand therapy predicts overall survival in patients with mCRPC: monocentric evaluation of a prospective registry.2024 · Eur J Nucl Med Mol Imaging · Prospective
- PSMA as a Theranostic Target in Hepatocellular Carcinoma: Immunohistochemistry and 68 Ga-PSMA-11 PET Using Cyclotron-Produced 68 Ga.2022 · Hepatol Commun · Prospective
- Lutetium-177-PSMA-617 in Low-Volume Hormone-Sensitive Metastatic Prostate Cancer: A Prospective Pilot Study.2021 · Clin Cancer Res · Prospective
- Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted β-emitting radionuclide therapies in metastatic castration-resistant prostate cancer.2021 · Prostate · Prospective · Phase I/II
- Efficacy and safety of 225Ac-PSMA-617 targeted alpha therapy in metastatic castration-resistant Prostate Cancer patients.2020 · Theranostics · Prospective
- Predicting hematologic toxicity of lutetium-177 prostate-specific membrane antigen therapy in metastatic castration-resistant prostate cancer using pretreatment gallium-68 prostate-specific membrane antigen positron emission tomography imaging: preliminary data in Asian patients.2026 · Nucl Med Commun · Retrospective
- Predictive value of metastatic distribution patterns on [68Ga]Ga-PSMA PET/CT for [177Lu]Lu-PSMA therapy.2026 · Rev Esp Med Nucl Imagen Mol (Engl Ed) · Retrospective
- Prognostic Value of AI-Assisted Lesion Tracking on End-of-Treatment PSMA PET in mCRPC Patients Treated with 177Lu-PSMA: A Retrospective, Single-Center Study.2025 · J Nucl Med · Retrospective
- Eliminating the second CT scan of dual-tracer total-body PET/CT via deep learning-based image synthesis and registration.2025 · Eur J Nucl Med Mol Imaging · Retrospective
- Efficacy and safety of rechallenge with [177Lu]Lu-PSMA-I&T radioligand therapy in metastatic castration resistant prostate cancer.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- Detection of tumour heterogeneity in patients with advanced, metastatic castration-resistant prostate cancer on [68Ga]Ga-/[18F]F-PSMA-11/-1007, [68Ga]Ga-FAPI-46 and 2-[18F]FDG PET/CT: a pilot study.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- PSMA-PET follow-up to assess response in patients not receiving PSMA therapy: Is there value beyond localization of disease?2024 · Theranostics · Retrospective
- Assessing Krenning's score on 68 Ga-DOTATATE PET-CT and miPSMA score on 68 Ga-PSMA-11 PET-CT in TENIS: a comparison with FDG PET/CT and examining the feasibility of targeted radionuclide therapy.2024 · Nucl Med Commun · Retrospective
- Dual FDG/PSMA PET imaging to predict lesion-based progression of mCRPC during PSMA-RLT.2024 · Sci Rep · Retrospective
- FAPI PET uptake patterns after invasive medical interventions: a single center retrospective analysis.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- Antihormonal-Treatment Status Affects 68Ga-PSMA-HBED-CC PET Biodistribution in Patients with Prostate Cancer.2023 · J Nucl Med · Retrospective
- Hematologic toxicity profile and efficacy of [225Ac]Ac-PSMA-617 α-radioligand therapy of patients with extensive skeletal metastases of castration-resistant prostate cancer.2022 · Eur J Nucl Med Mol Imaging · Retrospective
- Response Assessment and Prediction of Progression-Free Survival by 68Ga-PSMA-11 PET/CT Based on Tumor-to-Liver Ratio (TLR) in Patients with mCRPC Undergoing 177Lu-PSMA-617 Radioligand Therapy.2021 · Biomolecules · Retrospective
- Molecular imaging and biochemical response assessment after a single cycle of [225Ac]Ac-PSMA-617/[177Lu]Lu-PSMA-617 tandem therapy in mCRPC patients who have progressed on [177Lu]Lu-PSMA-617 monotherapy.2021 · Theranostics · Retrospective
- Concept proposal for a six-tier integrated dual tracer PET-CT (68Ga-PSMA and FDG) image scoring system ('Pro-PET' score) and examining its potential implications in metastatic castration-resistant prostate carcinoma theranostics and prognosis.2021 · Nucl Med Commun · Retrospective
- The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval.2021 · Mol Imaging Biol · Retrospective
- [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial.2026 · Lancet · Clinical study · Phase III
- Phase I/IIa clinical trial of 68Ga-PSMA-11 synthesized by a newly developed automated module using cyclotron-generated 68Ga.2026 · Ann Nucl Med · Clinical study · Phase I/II
- Assessing PSMA Receptor Availability Using 68Ga-PSMA-11 PET/CT Following 177Lu-PSMA-617 Therapy Administration.2026 · Clin Nucl Med · Clinical study
- First-in-human evaluation of four novel PSMA-targeted PET radiotracers with non-canonical amino acid linkage: A comparative study.2026 · Pharmacol Res · Clinical study
- Quantitative dual-tracer PET/CT biomarkers correlate concordant lesion uptake with PSMA-RLT outcomes in mCRPC: a dual-center study.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Inter-tumor Heterogeneity of 68 Ga-PSMA-11 Uptake in Metastatic Undifferentiated Sarcoma.2026 · Clin Nucl Med · Clinical study
- Deep Learning for Automated Measures of SUV and Molecular Tumor Volume in [68Ga]PSMA-11 or [18F]DCFPyL, [18F]FDG, and [177Lu]Lu-PSMA-617 Imaging with Global Threshold Regional Consensus Network.2025 · J Nucl Med · Clinical study
- Tumor sink effect in PSMA-targeted theranostics: intra-patient evaluation of a cohort receiving 225Ac/177Lu-PSMA tandem radioligand therapy.2025 · Q J Nucl Med Mol Imaging · Clinical study
- Health-related quality of life, pain, and symptomatic skeletal events with [177Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial.2025 · Lancet Oncol · Clinical study · Phase III
- Staging of prostate Cancer with ultra-fast PSMA-PET scans enhanced by AI.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Intra-arterial administration of PSMA-targeted radiopharmaceuticals for brain tumors: is the era of interventional theranostics next?2024 · Expert Rev Anticancer Ther · Clinical study
- Tubarial salivary glands show a low relative contribution to functional salivary gland tissue mass.2024 · Ann Nucl Med · Clinical study
- Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [161Tb]Tb-PSMA-I&T.2024 · J Nucl Med · Clinical study · Phase I/II
- Comparison of novel PSMA-targeting [177Lu]Lu-P17-087 with its albumin binding derivative [177Lu]Lu-P17-088 in metastatic castration-resistant prostate cancer patients: a first-in-human study.2024 · Eur J Nucl Med Mol Imaging · Clinical study
- Automated segmentation of lesions and organs at risk on [68Ga]Ga-PSMA-11 PET/CT images using self-supervised learning with Swin UNETR.2024 · Cancer Imaging · Clinical study
- Synthesis, Preclinical Evaluation, and First-in-Human PET Study of [68Ga]-Labeled Biphenyl-Containing PSMA Tracers.2023 · J Med Chem · Clinical study
- Eligibility for 177Lu-PSMA Therapy Depends on the Choice of Companion Diagnostic Tracer: A Comparison of 68Ga-PSMA-11 and 99mTc-MIP-1404 in Metastatic Castration-Resistant Prostate Cancer.2023 · J Nucl Med · Clinical study
- [89Zr]Zr-PSMA-617 PET/CT in biochemical recurrence of prostate cancer: first clinical experience from a pilot study including biodistribution and dose estimates.2022 · Eur J Nucl Med Mol Imaging · Clinical study
- Analysis of Pros and Cons in Using [68Ga]Ga-PSMA-11 and [18F]PSMA-1007: Production, Costs, and PET/CT Applications in Patients with Prostate Cancer.2022 · Molecules · Clinical study
- Combined 177 Lu-PSMA-617 PRLT and abiraterone acetate versus 177 Lu-PSMA-617 PRLT monotherapy in metastatic castration-resistant prostate cancer: An observational study comparing the response and durability.2021 · Prostate · Clinical study
- Total tumor volume reduction and low PSMA expression in patients receiving Lu-PSMA therapy.2021 · Theranostics · Clinical study
- PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer.2021 · J Nucl Med · Clinical study
- PSMA PET/CT Identifies Intrapatient Variation in Salivary Gland Toxicity From Iodine-131 Therapy.2020 · Mol Imaging · Clinical study
- Semiautomatically Quantified Tumor Volume Using 68Ga-PSMA-11 PET as a Biomarker for Survival in Patients with Advanced Prostate Cancer.2020 · J Nucl Med · Clinical study
- 68Ga-Prostate-Specific Membrane Antigen Uptake in Cerebral Tuberculosis.2020 · Clin Nucl Med · Clinical study
- Evaluation of an Automated Module Synthesis and a Sterile Cold Kit-Based Preparation of 68Ga-PSMA-11 in Patients with Prostate Cancer.2020 · J Nucl Med · Clinical study
- Therapeutic efficacy, prognostic variables and clinical outcome of 177Lu-PSMA-617 PRLT in progressive mCRPC following multiple lines of treatment: prognostic implications of high FDG uptake on dual tracer PET-CT vis-à-vis Gleason score in such cohort.2019 · Br J Radiol · Clinical study
- 68Ga-RM2 PET in PSMA- positive and -negative prostate cancer patients.2019 · Nuklearmedizin · Clinical study
- Preclinical investigations and first-in-human application of 152Tb-PSMA-617 for PET/CT imaging of prostate cancer.2019 · EJNMMI Res · Clinical study
- DNA damage in human whole blood caused by radiopharmaceuticals evaluated by the comet assay.2019 · Mutagenesis · Clinical study
- Cold Kit for Prostate-Specific Membrane Antigen (PSMA) PET Imaging: Phase 1 Study of 68Ga-Tris(Hydroxypyridinone)-PSMA PET/CT in Patients with Prostate Cancer.2018 · J Nucl Med · Clinical study · Phase I
- Comparison of PSMA-HBED and PSMA-I&T as diagnostic agents in prostate carcinoma.2017 · Eur J Nucl Med Mol Imaging · Clinical study
- Pilot Comparison of ⁶⁸Ga-RM2 PET and ⁶⁸Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer.2016 · J Nucl Med · Clinical study
- 177 Lu-PSMA-617 Therapy in a Case of Metastatic Castration-Resistant Prostate Cancer.2024 · Clin Nucl Med · Case report
- Increased PSMA Expression in 177 Lu-PSMA-617 Scan in Metastatic Castrate-Resistant Prostate Cancer Patient Treated With PSMA Radioligand Therapy and Enzalutamide : A Potential Game-Changer.2023 · Clin Nucl Med · Case report
Precursor
- Common precursor
- PSMA-11 (HBED-CC conjugate) PMID 32080309 / DOI 10.1038/s41598-020-60099-y
- Suppliers seen in the literature
- PSMA-11 (Glu-NH-CO-NH-Lys(Ahx)-HBED-CC) precursor from ABX (Radeberg, Germany); also supplied as sterile cold kits (ANMI SA, Liege, Belgium; and the licensed Locametz / Illuccix kits)
- Cited suppliers in indexed syntheses
- ABX, Advanced Biochemical Compounds, Iason GmbH, Novartis, POLATOM, Telix Pharmaceuticals
- Typical final purification
- SPE
Need this precursor?We can point you to suppliers for [68Ga]Ga-PSMA-11, or handle the enquiry for you.
Get in touchQuality control Pharmacopoeial monograph
- Ph. Eur. monograph
- 3044 Gallium (68Ga) PSMA-11 injection
- USP monograph
- not verified the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. Base set per Ph. Eur. 0125 + monograph 3044. Ge-68 breakthrough + metal impurities: generator-produced Ga-68 only. RECOMMEND ADD: molar activity / peptide content — PSMA-11 is a saturable-target receptor ligand and monograph 3044 controls peptide content.
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [68Ga]Ga-PSMA-11.
Get in touchNotes
Produced both from generator and from liquid- and solid-target cyclotron Ga-68.