Tracer library / [68Ga]Ga-PSMA-617
[68Ga]Ga-PSMA-617
Also written as 68Ga-PSMA-617; [68Ga]Ga-PSMA-617; [Ga-68]Ga-PSMA-617; PSMA-617
- Radionuclide
- Ga-68 t½ 67.71 min
- Modality
- PET
- Production route
- —
- Stage
- Clinical research
- Syntheses indexed
- 9
What it is
- Compound class
- PSMA-targeted urea-based small-molecule inhibitor (PSMA-617)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA) inhibitor PMID 38424422
- Clinical application
- PET/CT imaging for staging, restaging and detection of biochemical relapse in prostate cancer PMID 35056066
- Theranostic pair
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| GAIA Elysia-Raytest | vendor cassette | SPE | <20% with 20 µg; not explicitly stated with 40 µg | 97.4% ± 1.1% (TLC); 93.6% ± 0.9% (HPLC) | PSMA-617 MedChemExpress | 38424422 2024 Curr Radiopharm A GAIA® synthesis module and a GALLIAD® generator were used. - Initial experiments with the automated method described above involving only 20 µg of PSMA-617 were conducted, and were associated with low RCY (<20%). |
| Manual synthesis | custom manifold | SPE | >95 decay-corrected | >99% | PSMA-617 | 38512591 2024 EJNMMI Radiopharm Chem the possibility to perform an organic-solvent-free purification represents a major simplification. - SPE work-up afforded a significantly higher recovery of > 95% |
| — | custom manifold | none | — | ≥96% | PSMA-617 Jenguro Ltd., Moscow, Russia | 42653427 2026 Int J Mol Sci |
| Manual synthesis | — | — | >94% | >94% | PSMA-617 | 41510166 2026 Theranostics Radiolabeling with [177Lu]Lu3+ was completed by the addition of precursor peptides PS1 - PS11 - radiochemical yields of greater than 94% for the 68Ga-labeled and greater than 96% for the 177Lu-labeled compounds |
| Manual synthesis | — | — | — | — | PSMA-617 | 41407974 2026 Eur J Nucl Med Mol Imaging 1 mL of 68GaCl3 (187 MBq) was added to 90 µL NaOAc (1.5 M) and reacted with 10 µg AP-01 or PSMA-617 at 100 °C for 10 min to acquire 68Ga-AP-01 and 68Ga-PSMA-617, respectively |
| Manual synthesis | — | — | >90% | >95% | PSMA-617 | 39563828 2024 ACS Med Chem Lett [68Ga]Ga, Hepes buffer (0.25 M), pH = 4.0, 95 °C, 30 min. - radiochemical yield was over 90% |
| GAIA Elysia-Raytest | vendor cassette | SPE | — | 97.4% ± 1.1% mean RCP by TLC; mean RCP by HPLC = 93.6% ± 0.9% | PSMA-617 MedChemExpress | 38424422 2024 Curr Radiopharm For [68Ga]Ga-PSMA-617 preparation, the automated sequence described above was used unchanged. |
| Manual synthesis | — | none | >95% | >98% | PSMA-617 | 36015144 2022 Pharmaceuticals (Basel) The radiolabeling was performed by incubating PSMA-617 (20 nmol) with 1–1.2 GBq of 68GaCl3 (adjusted to pH 3.8 with 1 M ammonium acetate buffer, pH 4.5) at 95 °C for 12 min. - This tracer [9] is routinely prepared in our center with a radiochemical yield higher than 95%, as determined by UPLC (Figure S9). |
| Manual synthesis n/a | — | — | — | >99% | PSMA-617 | 42300211 2026 Org Biomol Chem Purified PSMA-617 was radiolabelled with 68Ga in >99% radiochemical purity, confirming chemical integrity. |
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.
- First-in-human evaluation of [18F]-AlF-NOTA-neurotensin for NTSR1-targeted imaging of prostate cancer: a head-to-head comparison with [68Ga]Ga-PSMA-617.2026 · Ann Med · Prospective
- Prospective head-to-head comparison of [68Ga]Ga-RM2 PET/CT and [68Ga]Ga-PSMA-617 PET/CT in newly diagnosed patients with intermediate-risk localized prostate cancer.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
- Dual-tracer PET/CT with [68Ga]Ga-PSMA-617 and [68Ga]Ga-RM26 improves early prediction of biochemical failure in prostate cancer: a prospective phase II trial.2026 · Eur J Nucl Med Mol Imaging · Prospective · Phase II
- The tumour sink effect on 68Ga-PSMA-PET/CT in metastatic castration-resistant prostate cancer and its implications for PSMA-RPT: a sub-analysis of the 3TMPO study.2025 · Cancer Imaging · Prospective
- [68Ga]Ga-PSMA-617 PET/MRI for imaging patients suspected of hepatocellular carcinoma.2025 · Eur J Nucl Med Mol Imaging · Prospective
- Intrapatient Intermetastatic Heterogeneity Determined by Triple-Tracer PET Imaging in mCRPC Patients and Correlation to Survival: The 3TMPO Cohort Study.2024 · J Nucl Med · Prospective
- A prospective comparative study of [68Ga]Ga-RM26 and [68Ga]Ga-PSMA-617 PET/CT imaging in suspicious prostate cancer.2023 · Eur J Nucl Med Mol Imaging · Prospective
- Comparison of 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study.2023 · J Nucl Med · Prospective · Phase II
- Head-to-Head Comparison of mpMRI, PSMA, GRPR PET/CT, and PET/CT Plus MRI for Local Staging of Primary Prostate Cancer and Their Prognostic Value.2026 · J Nucl Med · Retrospective
Show all 29 clinical studies
- 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
- The additive value of 68Ga-RM26 PET/CT to 68Ga-PSMA-617 PET/CT in assessing Post-treatment outcomes of ARSIs in mCRPC patients.2025 · Eur J Nucl Med Mol Imaging · Retrospective
- Physiological biodistribution on Ga68-PSMA PET/CT and the factors effecting biodistribution.2024 · Ann Nucl Med · Retrospective
- Differences in Distribution and Detection Rate of the [68Ga]Ga-PSMA Ligands PSMA-617, -I&T and -11-Inter-Individual Comparison in Patients with Biochemical Relapse of Prostate Cancer.2021 · Pharmaceuticals (Basel) · Retrospective
- Evaluation of [68Ga]Ga-PSMA PET/CT for therapy response assessment of [177Lu]Lu-PSMA radioligand therapy in metastasized castration refractory prostate cancer and correlation with survival.2021 · Nucl Med Commun · Retrospective
- The Establishment of New Thresholds for PLND-Validated Clinical Nomograms to Predict Non-Regional Lymph Node Metastases: Using 68Ga-PSMA PET/CT as References.2021 · Front Oncol · Retrospective
- Analysis of PSMA expression and outcome in patients with advanced Prostate Cancer receiving 177Lu-PSMA-617 Radioligand Therapy.2020 · Theranostics · Retrospective
- Preclinical and First-In-Human Evaluation of 68Ga-PSMA-33, a Novel PSMA Radiotracer with Low Background Signal.2026 · ACS Omega · Clinical study
- Integrating PET and Fluorescence Imaging with a Novel PSMA-ICG Conjugate for Prostate Cancer Management.2026 · Mol Pharm · 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
- Linker Manipulation with Beta3-Amino Acids Potentiates the Efficacy and Safety of PSMA Radiopharmaceuticals.2026 · Adv Healthc Mater · Clinical study
- PSMA PET/CT based multimodal deep learning model for accurate prediction of pelvic lymph-node metastases in prostate cancer patients identified as candidates for extended pelvic lymph node dissection by preoperative nomograms.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Preliminary evaluation of a novel PSMA-targeting radiopharmaceutical [68Ga]Ga/[177Lu]Lu-NYM032 for theranostic use in prostate cancer.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- A pilot study of 68 Ga-PSMA-617 PET/CT imaging and 177Lu-EB-PSMA-617 radioligand therapy in patients with adenoid cystic carcinoma.2022 · EJNMMI Res · Clinical study
- mCRPC Patients Receiving 225Ac-PSMA-617 Therapy in the Post-Androgen Deprivation Therapy Setting: Response to Treatment and Survival Analysis.2022 · J Nucl Med · Clinical study
- 68Ga-labeled ODAP-Urea-based PSMA agents in prostate cancer: first-in-human imaging of an optimized agent.2022 · Eur J Nucl Med Mol Imaging · Clinical study
- Predictors of Overall and Disease-Free Survival in Metastatic Castration-Resistant Prostate Cancer Patients Receiving 225Ac-PSMA-617 Radioligand Therapy.2020 · J Nucl Med · Clinical study
- 225Ac-PSMA-617 in chemotherapy-naive patients with advanced prostate cancer: a pilot study.2019 · Eur J Nucl Med Mol Imaging · Clinical study
- 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
Precursor
- Common precursor
- —
- Suppliers seen in the literature
- —
- Cited suppliers in indexed syntheses
- Jenguro Ltd., MedChemExpress
- Typical final purification
- —
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Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- not verified No Ph. Eur. check is recorded for this entry.
- USP monograph
- not verified No USP check is recorded for this entry.
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator-produced per synthesis data (PMID 27090254) -> Ge-68 breakthrough; receptor ligand with a saturable target -> molar activity (rule)
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-617.
Get in touchNotes
Stage 8: 2 corpus articles with Ga-68 PSMA-617 (PMID 40638023, 40441170) were collapsed onto the In-111 anchor. Added. Compound class inferred from precursor name (not stated outright) -- PMID 38424422: 'PSMA-617'. Stage set/updated at stage 23 from PMID 36215569: 'Comparison of 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study.'. | Stage 30 (2026-09-18): Stage was 'Phase II clinical trial'; normalised to 'Clinical research', original wording kept here.