Tracer library / [177Lu]Lu-PSMA-617
[177Lu]Lu-PSMA-617
Also written as 177Lu-PSMA-617; [177Lu]Lu-PSMA-617; [177Lu]Lu-PSMA617; [Lu-177]Lu-PSMA-617; Lu-177 PSMA-617; lutetium (177Lu) vipivotide tetraxetan; PSMA-617
- Radionuclide
- Lu-177 t½ 9585 min
- Modality
- Therapy
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 35
What it is
- Compound class
- PSMA-617 (DOTA-conjugated urea-based PSMA-targeting small molecule ligand)
- Target / mechanism
- Targets prostate-specific membrane antigen (PSMA); binding results in internalisation and delivery of β-radiation into PSMA-expressing cancer cells PMID 37284895; PMID 36288537
- Clinical application
- PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer PMID 38725500; PMID 36288537
- Theranostic pair
- [68Ga]Ga-PSMA-11
Regulatory status
- FDA
- Yes — 2022; Pluvicto (lutetium Lu 177 vipivotide tetraxetan); sponsor NOVARTIS; NDA 215833 Drugs@FDA / openFDA drug registry, NDA 215833, original approval 2022-03-23, marketing status 'Prescription' — https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215833%22 (queried 2026-09-18)
- EMA (centralised)
- Yes — 2022; Pluvicto (lutetium (177Lu) vipivotide tetraxetan); Novartis Europharm Limited; EMEA/H/C/005483 EMA medicines register (JSON export 2026-09-18), EPAR Pluvicto: status 'Authorised', marketing authorisation date 2022-12-09 — https://www.ema.europa.eu/en/medicines/human/EPAR/pluvicto
- Other approvals
- —
- Brand names
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | none | 91 ± 4 decay-corrected | 96.6 ± 0.7 | PSMA-617 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. |
| — Elysia-Raytest | vendor cassette | none | >96% not corrected | >95% | PSMA-617 (vipovitide tetraxetan) MedChemExpress | 42287471 2026 EJNMMI Radiopharm Chem Radiopharmaceutical [177Lu]Lu-PSMA-617 was synthetized by the Gaia&Luna module (Elysia Raytest, Germany). - The radiopharmaceutical was obtained with > 95% radiochemical purity and > 96% radiochemical yield. |
| — | — | — | — | >95% | PSMA-617 MedChemExpress | 36145382 2022 Pharmaceuticals (Basel) |
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | SPE | 90.1 ± 0.8% | >99% TLC, >98% HPLC | PSMA-617 Gamma Servizi s.r.l., Pavia, Italy | 29097938 2017 Contrast Media Mol Imaging The ML Eazy system was also tested to prepare 90Y- and 177Lu-PSMA-617 - 90.1 ± 0.8% (n = 5), for yttrium-90 and lutetium-177, respectively, were achieved |
| Manual synthesis | — | SPE | 72 ± 6% not corrected | >95% | PSMA-617 MedChemExpress | 42654126 2026 Pharmaceutics PSMA-617 (10 mM in DMSO), sodium acetate (0.4 M, pH 5.5), 20% ascorbic acid solution, and approximately 185-370 MBq of 177Lu-LuCl3 ... were combined in a reaction vial, and incubated at 95 °C for 60 min. - The non-decay-corrected radiochemical yield was 72 ± 6% |
| — Elysia-Raytest | vendor cassette | none | >96% not corrected | >95% | PSMA-617 (vipovitide tetraxetan) MedChemExpress | 42287471 2026 EJNMMI Radiopharm Chem Radiopharmaceutical [177Lu]Lu-PSMA-617 was synthetized by the Gaia&Luna module (Elysia Raytest, Germany). - The radiopharmaceutical was obtained with > 95% radiochemical purity and > 96% radiochemical yield. |
| Kit-based preparation | — | — | — | 95.6 | — | 42287471 2026 EJNMMI Radiopharm Chem reference product (Pluvicto®) |
| Manual synthesis | — | SPE | >95% | >98% | PSMA-617 Novartis | 42159963 2026 EJNMMI Radiopharm Chem In a 1.5 mL protein Eppendorf tube (LoBind®), approximately 37.0 MBq of 177LuCl3 in 0.25 M NaOAc buffer (pH 5.5, 100 µL) or 18.5 MBq of 212PbCl2 in 0.2 M NaOAc buffer (pH 5.5, 100 µL) was mixed with PSMA-617 (1.0 nmol, 1.0 µL). - isolated radiochemical yield of > 95% for [177Lu]Lu-PSMA-617 |
| Manual synthesis | — | — | — | — | PSMA-617 | 41407974 2026 Eur J Nucl Med Mol Imaging 37–187 MBq of 177LuCl3 was mixed with 10 µL of 0.5 M NaOAc (pH = 5.5) and incubated with AP-01 or PSMA-617 (10–20 µg) at 90 °C for 20 min, respectively |
| Kit-based preparation Novartis | — | — | — | — | PSMA-617 Novartis | 40897948 2025 Mol Imaging Biol [177Lu]Lu-PSMA-1-DOTA was labeled by 3D Imaging, LCC with clinical grade [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) used as positive control for RLT. |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | — | 99 ± 5% not corrected | 95.8 ± 1.6% 0h HPLC | PSMA-617 ABX | 40696084 2025 EJNMMI Radiopharm Chem This process was automated using an iPHASE MultiSyn radiochemistry module with sterile kits affording sterile and apyrogenic 177Lu-labeled radiopharmaceuticals in non-decay corrected yields > 95%. - yielding 99 ± 5%. |
| Manual synthesis | — | — | — | >95% | PSMA-617 ligand MedKoo Biosciences | 40397137 2025 Eur J Nucl Med Mol Imaging The PSMA-617 ligand (MedKoo Biosciences) was prepared as described by Stenberg et al. |
| Manual synthesis | — | — | — | — | PSMA-617 precursor MedChemExpress | 40049746 2025 J Nucl Med All radiopharmaceuticals were radiolabeled, formulated, and quality-controlled using optimized versions of previously described methods (15). |
| Manual synthesis | — | SPE | 99.5 ± 0.5% | >97% | PSMA-617 Jenguro Ltd., Moscow, Russia | 39771514 2024 Pharmaceutics The synthesis was carried out in Eppendorf Safe-Lock tubes (1.5, 2.0, or 5 mL) at temperatures of 24.5 (RT), 50, 75, 82, and 95 °C with Eppendorf ThermoMixer® C (Hamburg, Germany). - a nearly quantitative reaction yield (99.5 ± 0.5%) may be observed after 10 min of incubation even at ambient temperature (RT, 24.5 °C) |
| Manual synthesis CEM Corporation | — | — | 98.1 ± 1.2% | ≥97.5% | PSMA-617 Jenguro Ltd., Moscow, Russia | 39771514 2024 Pharmaceutics For microwave heating, the reaction was performed with a CEM Discover 908005 Microwave Synthesis System in Biotage® Microwave Reaction Vials (Uppsala, Sweden). - radiochemical yields of ~98% were achieved in 1 (98.1 ± 1.2%) and 5 (98.2 ± 1.1%) min at sodium acetate concentrations of 0.1 and 1.0 mol/L, respectively |
| Manual synthesis | — | — | >90% | >95% | PSMA-617 | 39563828 2024 ACS Med Chem Lett [177Lu]LuCl3, Na–Ac buffer (400 nM), pH = 5.0, 98 °C, 25 min. - radiochemical yield was over 90% |
| Manual synthesis | — | none | 94.29 ± 0.01% | 94.29 ± 0.01% | PSMA-617 | 39083135 2024 EJNMMI Radiopharm Chem 177Lu-PSMA-617 was prepared by successively adding 177LuCl3 solution (5 µL, 40.7 MBq), PSMA-617 (0.22 mmol/L, 30 µL, 6.7 nmol; prepared in 0.5 M HAc-NaAc buffer, pH 5.2), and gentisic acid (65.00 mmol/L, 40 µL, 2600 nmol) in a reaction flask. - 177Lu-PSMA-61795 ℃5.015 min94.29 ± 0.01%94.29 ± 0.01% |
| Manual synthesis | — | — | — | — | PSMA-617 | 38725500 2024 Chem Sci The corresponding DOTA conjugates were labeled with 177Lu (compound 18 and Pluvicto™) |
| Manual synthesis | — | SPE | 90% | >95% | PSMA-617 | 38700450 2024 Adv Healthc Mater PSMA-617 in water (25 μg per 25 μL) was added to 925 MBq of 177Lu in 250 μL 0.18 M ascorbic acid solution and the solution was shaken at 95 °C for 40 min - The isolated radiochemical yield after cartridge purification was 90%, with greater than 95% purity and molar activity was 41.68 MBq/nmol. |
| Manual synthesis | — | — | — | — | PSMA-617 precursor ABX | 37797974 2023 J Nucl Med Radiolabeling was performed as previously described |
| Manual synthesis | — | HPLC+SPE | — | — | PSMA-617 | 37649602 2023 Theranostics [177Lu]LuCl3 (~500 MBq in ~15 μL) was added to a solution of the DOTA-conjugated precursor (25 μg) in NaOAc buffer (0.5 mL, 0.1 M, pH 4.5). The mixture was incubated at 90 °C for 15 min |
| Manual synthesis | — | — | — | — | PSMA-617 ABX | 37284895 2023 Naunyn Schmiedebergs Arch Pharmacol PSMA-617 (60 µg) mixed with 740 µl of gentensic solution (3 mg/ml dissolved in 0.4 M sodium acetate, pH = 4.6) was added to 163 µl of the 177LuCl3 solution. The buffered solution was heated for 20 min at 92 °C and diluted with saline to reach a final activity of 1 GBq/ml. |
| — | — | HPLC | — | — | PSMA-617 | 36168623 2022 Theranostics |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | — | — | PSMA-617 ABX | 36166155 2022 EJNMMI Radiopharm Chem [177Lu]Lu-PSMA-I&T and [177Lu]Lu-PSMA-617 was produced with a Scintomics GRP module |
| Manual synthesis | — | — | — | — | PSMA-617 | 35807385 2022 Molecules For the radiolabeling of [177Lu]Lu-PSMA-I&T, a manual synthesis was used. |
| Manual synthesis | — | none | — | ≥ 98% | PSMA-617 | 35635566 2022 Eur J Nucl Med Mol Imaging The radiolabeling of the PSMA ligands with lutetium-177 (no-carrier-added; in 0.04 M HCl; ITM Medical Isotopes GmbH, Germany) was performed under standard labeling conditions at pH 4.5 as previously reported |
| Manual synthesis | — | — | — | >95% | PSMA-617 precursor | 35086894 2022 J Nucl Med 177Lu labeling of PSMA ligands according to standard manual procedures resulted in a radiochemical purity of more than 95% |
| Manual synthesis | — | — | >98 | >98 | PSMA-617 ABX | 34932154 2022 Eur J Nucl Med Mol Imaging For the biodistribution study, 18 µg PSMA ligand (15 nmol PSMA-617, 12 nmol PSMA-I&T) was added to 0.5 M MES buffer, pH 5.5, and 33 MBq [177Lu]LuCl3 - Radiolabeling of PSMA-617 and PSMA-I&T with [177Lu]LuCl3 resulted in radiochemical yield of > 98% |
| Manual synthesis | — | none | — | ≥ 95% | PSMA-617 | 34402925 2022 Eur J Nucl Med Mol Imaging The radiolabeling of Ibu-DAB-PSMA and PSMA-617 was performed under standard labeling conditions at pH 4.5 using lutetium-177 |
| Manual synthesis | — | — | — | — | PSMA-617 ABX | 33579037 2021 Biomolecules Radiolabeling was conducted as previously described by Kratochwil et al. [34]. 1 GBq of non-carrier added Lutetium-177 (ITG GmbH, Garching, Germany), 30–40 MBq/µL, was mixed with 100 µL sterile 0.4 M sodium acetate solution, pH 5.5, and 1.25 µL 20% w/w ascorbic acid solution; thereafter, 2 µL of a 10 mM solution of PSMA-617 (ABX, Radeberg, Germany) was added. |
| Manual synthesis | — | — | >95% | >90% | PSMA-617 Advanced Biochemical Compounds, ABX, Germany | 33094433 2021 Eur J Nucl Med Mol Imaging Labeling of PSMA-617, PSMA-I&T, and JVZ-007 was performed as previously described - For all labelings, the radiochemical yield was > 95% and the radiochemical purity was > 90%. |
| Manual synthesis | — | — | 99% | — | — | 31891883 2020 Nucl Med Biol labeling yield of [177Lu]Lu-PSMA-617 was measured as a function of reaction time by sampling 2 μL crude product (925 kBq/μL) at different time points and spotting on a TLC plate - high labeling efficiency (99%) can be achieved in just 10 min |
| Manual synthesis | — | HPLC | >98% | >99% | — | 31399803 2019 Eur J Nucl Med Mol Imaging All compounds were synthesized using solution-phase chemistry based on our well-established methods - All ligands were radiolabeled with 177Lu in high radiochemical yield (> 98%) and purity (> 99%) using both conventional and microwave-assisted methods. |
| — | — | — | 98% | — | PSMA-617 | 40425733 2026 Nat Protoc |
| Manual synthesis n/a | — | — | — | — | — | 35895995 2022 Mol Pharm RIMS-1 was generated using a convergent synthesis employing solid phase peptide and solution chemistries |
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.
- PROQURE-I: a phase I study adding concurrent [177Lu]Lu-PSMA-617 to EBRT and ADT in curative intent treatment of N1 prostate cancer.2026 · Eur J Nucl Med Mol Imaging · Multicentre · Phase I
- PSMA PET/CT-Derived Indicators and Outcomes After [177Lu]Lu-PSMA-617: A Multicenter Retrospective Analysis from the U.S. Expanded-Access Program.2026 · J Nucl Med · Retrospective, multicentre
- 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
- Comparison of two alternative sequences with cabazitaxel and 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer: A retrospective multicenter study (LuCaS).2025 · Eur J Cancer · Retrospective, multicentre
- The real-world outcomes of Lutetium-177 PSMA-617 radioligand therapy in metastatic castration-resistant prostate cancer: Turkish Oncology Group multicenter study.2024 · Int J Cancer · Retrospective, multicentre
- Real-world Outcomes and Predictive Biomarkers for 177Lutetium Prostate-specific Membrane Antigen Ligand Treatment in Metastatic Castration-resistant Prostate Cancer: A European Association of Urology Young Academic Urologists Prostate Cancer Working Group Multi-institutional Observational Study.2024 · Eur Urol Oncol · Retrospective, multicentre
- Safety of PSMA-Targeted Molecular Radioligand Therapy with 177Lu-PSMA-617: Results from the Prospective Multicenter Phase 2 Trial RESIST-PC (NCT03042312).2021 · J Nucl Med · Prospective, multicentre · Phase II
- ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901).2021 · BJU Int · Multicentre · Phase II
- Prospective phase 2 trial of PSMA-targeted molecular RadiothErapy with 177Lu-PSMA-617 for metastatic castration-reSISTant Prostate Cancer (RESIST-PC): efficacy results of the UCLA cohort.2021 · J Nucl Med · Prospective, multicentre · Phase II
- [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
Show all 82 clinical studies
- 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
- Plasma extracellular vesicle proteomics nominates candidate biomarkers of 177Lu-PSMA-617 outcomes in metastatic prostate cancer patients.2026 · Cell Rep Med · Prospective
- High-purity CTC RNA sequencing identifies prostate cancer lineage phenotypes prognostic for clinical outcomes.2025 · Cancer Discov · 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-heterogeneity in metastatic castration-resistant prostate cancer: Circulating tumor cells, metastatic tumor burden, and response to targeted radioligand therapy.2023 · Prostate · 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
- Efficacy and Safety of 177Lu-PSMA-617 Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer Patients.2020 · Clin Nucl Med · Prospective
- The predictive role of [177Lu]Lu-PSMA-617 SPECT/CT semiquantitative parameters from the 1st RLT cycle in advanced mCRPC: a preliminary bicentric lesion-based analysis.2026 · Eur J Nucl Med Mol Imaging · Retrospective
- Cost-Effectiveness Analysis of 177Lu-PSMA-617 Versus Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer from a U.S. Health Care Perspective.2026 · J Nucl Med · Retrospective
- Prognostic Value of Cycle 1 SPECT SUVmean in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with 177Lu-PSMA-617.2026 · J Nucl Med · Retrospective
- Prompt PSA changes as a prognostic marker for response to PSMA-radioligand therapy.2026 · Eur J Nucl Med Mol Imaging · Retrospective
- Linking Baseline PSMA PET-Derived Parameters to Toxicity, Adverse Events, Pain, and Quality of Life in Patients Treated with [177Lu]Lu-PSMA-617: A Single-Center Retrospective Study.2026 · J Nucl Med · Retrospective
- 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
- Efficacy and safety of Lutetium-177 (177Lu)-PSMA-617 in metastatic Castration-Resistant prostate cancer patients with superscan pattern: A retrospective cohort study.2026 · Ann Nucl Med · Retrospective
- Bone matters: Ga-68 PSMA PET/CT volumetrics predict PSA-PFS and OS in bone-dominant mCRPC patients treated with [¹⁷⁷Lu]Lu-PSMA-617.2026 · Eur J Nucl Med Mol Imaging · Retrospective
- Effect of bone marrow disease on hematologic toxicity and response to [177Lu]Lu-PSMA-617 therapy: insights from PSMA-PET/CT imaging.2026 · Eur J Nucl Med Mol Imaging · 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
- Bellmunt risk score enables survival prediction in men with metastatic castration resistant prostate cancer (mCRPC) undergoing PSMA-targeted radioligand therapy (LUMEN).2026 · Eur J Nucl Med Mol Imaging · 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
- Enhancing outcomes in mCRPC: the impact of androgen receptor inhibitor sequencing before 177Lu-PSMA-617 therapy.2025 · Oncologist · Retrospective
- Efficacy, Safety, Blood Kinetics, and 213Bi Distribution Studies of [225Ac]Ac-SibuDAB in Prostate Cancer Patients.2025 · J Nucl Med · Retrospective
- PSMA Radioligand Therapy in Advanced Age: Insights From an 85y+ mCRPC Patient Cohort.2025 · Clin Nucl Med · Retrospective
- Effect of body composition parameters, including sarcopenia, myosteatosis, and adipose tissue, on overall survival of patients with mCRPC receiving 177 Lu-PSMA PRRT.2025 · Nucl Med Commun · Retrospective
- Visceral metastases, platelet dynamics, and PSA decline: from biomarkers to better outcomes in [177Lu]Lu‑PSMA‑617 therapy in metastatic castration-resistant prostate cancer.2025 · Theranostics · Retrospective
- Outcome and Renal Safety of PSMA-Targeted Radioligand Therapy in mCRPC Patients With Preexisting Impaired Renal Function.2025 · Clin Nucl Med · 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
- Dual FDG/PSMA PET imaging to predict lesion-based progression of mCRPC during PSMA-RLT.2024 · Sci Rep · Retrospective
- Assessing Response to PSMA Radiopharmaceutical Therapies with Single SPECT Imaging at 24 Hours After Injection.2024 · J Nucl Med · 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
- Analysis of PSMA expression and outcome in patients with advanced Prostate Cancer receiving 177Lu-PSMA-617 Radioligand Therapy.2020 · Theranostics · Retrospective
- Clinical Variables Associated with PSA Response to Lutetium-177-PSMA ([177Lu]-PSMA-617) Radionuclide Treatment in Men with Metastatic Castration-Resistant Prostate Cancer.2020 · Cancers (Basel) · Retrospective
- Neuroendocrine Differentiation and Response to PSMA-Targeted Radioligand Therapy in Advanced Metastatic Castration-Resistant Prostate Cancer: A Single-Center Retrospective Study.2020 · J Nucl Med · Retrospective
- Clinical and economic outcomes of cabazitaxel versus Lu-PSMA in mCRPC: a US perspective.2026 · J Med Econ · Clinical study
- [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
- Leveraging [18F]F-Piflufolastat PET for PBPK Prediction of Tissue Distribution and Therapy Optimization in Prostate Cancer.2026 · Clin Transl Sci · Clinical study
- Predictive value of early PSMA upregulation for the response to enzalutamide ± 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer: substudy of the randomized, phase 2 ENZA-p trial.2026 · Nat Cancer · Clinical study · Phase II
- Assessing PSMA Receptor Availability Using 68Ga-PSMA-11 PET/CT Following 177Lu-PSMA-617 Therapy Administration.2026 · Clin Nucl Med · Clinical study
- 177 Lutetium-PSMA Therapy in a Patient With Concurrent Prostate Cancer and Renal Cell Carcinoma.2026 · Clin Nucl Med · Clinical study
- Excellent Response of Glioblastoma Multiforme to [ 177 Lu] Lu-PSMA Therapy.2026 · Clin Nucl Med · Clinical study
- PSMA-based Theranostics in Advanced Non-small Cell Lung Cancer: A Hit or a Miss?2026 · Clin Nucl Med · Clinical study
- Postmarketing safety of [177Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system.2026 · Expert Opin Drug Saf · Clinical study
- Prognostic Value of Initial Imaging and PSA Change with [177Lu]Lu-PSMA-617 Radiopharmaceutical Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: A ProsTIC Registry Analysis.2025 · J Nucl Med · Clinical study
- Adverse events associated with Lutetium-177-PSMA-617 (Pluvicto®) in advanced prostate cancer: a disproportionality analysis based on the fda's adverse event reporting system (FAERS).2025 · BMC Cancer · 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
- Final overall survival and safety analyses of the phase III PSMAfore trial of [177Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer.2025 · Ann Oncol · Clinical study · Phase III
- 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
- Expanding the scope of PSMA-RLT: evaluating treatment in challenging mCRPC patients with poor performance status (ECOG 3).2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Cost-utility analysis of 177Lu-PSMA-617 radioligand therapy in second-line and third-line treatment for metastatic castration-resistant prostate cancer (mCRPC) in Germany.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Clinical Trial Protocol for LuCAB: A Phase I-II Trial Evaluating Cabazitaxel in Combination with [177Lu]Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer.2025 · J Nucl Med · Clinical study · Phase I/II
- Safety of PSMA radioligand therapy in mCRPC patients with preexisting moderate to severe thrombocytopenia.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial.2024 · Lancet · Clinical study · Phase III
- Analysing the tumor transcriptome of prostate cancer to predict efficacy of Lu-PSMA therapy.2023 · J Immunother Cancer · Clinical study
- Cost-Effectiveness Analysis of 177Lu-PSMA-617 Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer.2023 · J Natl Compr Canc Netw · 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
- Long-term outcome of 177Lu-PSMA-617 radioligand therapy in heavily pre-treated metastatic castration-resistant prostate cancer patients.2021 · PLoS One · Clinical study
- Clinical Trial Protocol for LuTectomy: A Single-arm Study of the Dosimetry, Safety, and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy.2021 · Eur Urol Focus · Clinical study · Phase I/II
- Molecular analysis of circulating tumor cells of metastatic castration-resistant Prostate Cancer Patients receiving 177Lu-PSMA-617 Radioligand Therapy.2020 · Theranostics · 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
- Response Prediction of 177Lu-PSMA-617 Radioligand Therapy Using Prostate-Specific Antigen, Chromogranin A, and Lactate Dehydrogenase.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
- DNA damage in human whole blood caused by radiopharmaceuticals evaluated by the comet assay.2019 · Mutagenesis · Clinical study
- FAPI Uptake in Avascular Necrosis of the Talus.2026 · Clin Nucl Med · Case report
- PSMA Expression Heterogeneity in Metastatic Prostate Carcinoma: A Case of Discordant Liver Metastases on 68 Ga PSMA PET/CT Showing Uptake on Post-Lu-177 PSMA Therapy Scan.2026 · Clin Nucl Med · Case report
- 177 Lu-PSMA-617 Therapy in a Case of Metastatic Castration-Resistant Prostate Cancer.2024 · Clin Nucl Med · Case report
- Case Report: Long-term complete response to PSMA-targeted radioligand therapy and abiraterone in a metastatic prostate cancer patient.2023 · Front Oncol · 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
- —
- Suppliers seen in the literature
- —
- Cited suppliers in indexed syntheses
- ABX, Advanced Biochemical Compounds, Gamma Servizi s.r.l., Jenguro Ltd., MedChemExpress, MedKoo Biosciences, Novartis
- Typical final purification
- —
Need this precursor?We can point you to suppliers for [177Lu]Lu-PSMA-617, or handle the enquiry for you.
Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- no monograph none (general monograph 0125 applies)
- USP monograph
- not verified the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. No monograph — base set per Ph. Eur. 0125 + rule-based. Lu-177m content + metal impurities + molar activity + osmolality per rules (therapeutic radiometal, saturable target). HPLC essential for radiolysis products (draft note retained).
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
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Stage 8: PSMA-617 radioligand therapy agent. 7 corpus articles with Lu-177 were collapsed onto the In-111 anchor [111In]In-PSMA-617 by the isotope-blind key (PMID 42287471, 41249585, 41026359, 40908334, 39293462, 38512591, 34964165). Added as its own row. Theranostic hub: also paired (one-way) from f18-psma1007, f18-dcfpyl, in111-psma617 -- ga68-psma11 (Locametz/gozetotide) is the FDA-approved companion diagnostic for Lu-177-PSMA-617 (Pluvicto); the other three are additional PSMA-targeting diagnostics used with the same therapeutic in practice, not tracked back here to avoid a many-valued field. [stage 19] Compound class inferred from precursor name (not stated outright) -- PMID 27090254: 'The ligand PSMA-617 was purchased from ABX.'. Stage set/updated at stage 23 from PMID 38725500: 'Pluvicto™ is a PSMA-targeted radioligand therapeutic (RLT) recently approved by the FDA for the treatment of metastatic castration-resistant prostate cancer (2022 FDA marketing authorization).'. | Stage 33 (2026-09-19): merged lu177-lupsma617 ('[177Lu]Lu-LuPSMA-617') into this row -- the same substance ([177Lu]Lu-PSMA-617, Pluvicto) with a duplicated metal prefix in the name; decision confirmed by the user 2026-09-19. Alternative names, the indication onc-bone, the extra source PMID 36288537 and the 8 parsed runs were carried over.