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PSMA-T4 is a chemically synthesised substance supplied as a kit for radiopharmaceutical preparation.[1] The kit is used to prepare a radioactive tracer, [99mTc]Tc-PSMA-T4, by labelling PSMA-T4 with technetium-99m, a radioactive isotope commonly used in nuclear medicine imaging.[3] PSMA-T4 is an investigational substance with no marketing authorisation in the product records.[1] The product is supplied by the National Centre for Nuclear Research (Narodowe Centrum Badań Jądrowych) in Poland.[1]
PSMA-T4 binds to the prostate-specific membrane antigen (PSMA), a protein found in high amounts on the surface of prostate cancer cells.[4] When labelled with technetium-99m, the tracer emits gamma rays that can be detected by a SPECT/CT scanner. This allows doctors to see where PSMA-positive cancer cells are located in the body.[3] PSMA imaging has high sensitivity and specificity for detecting prostate cancer lesions, including metastases.[4] The same PSMA target is also used for targeted radioligand therapy in advanced prostate cancer, where particle-emitting radioligands are delivered to PSMA-positive cells.[4]
PSMA-T4 is supplied as a kit for radiopharmaceutical preparation and is given by intravenous injection.[1] In the clinical trials, the prepared tracer [99mTc]Tc-PSMA-T4 was administered at a dose of 740 megabecquerels (MBq).[1][2] After injection, patients undergo SPECT/CT imaging to visualise PSMA-positive lesions.[3]
Two phase 4 clinical trials have investigated PSMA-T4 in cancer imaging. The first trial, completed in 80 patients with prostate cancer, assessed the feasibility and safety of [99mTc]Tc-PSMA-T4 for diagnosis and treatment planning.[1] The primary outcome measured whether the imaging method could detect lesions confirmed by pathology or radiology, with a feasibility threshold of at least 80% sensitivity and specificity in two of the three patient cohorts.[1]
The second trial, authorised but not yet completed, is studying PSMA-T4 in 100 patients with triple-negative breast cancer undergoing radical therapy.[2] This trial aims to assess the prognostic value of [99mTc]Tc-PSMA-T4 SPECT/CT imaging by comparing imaging results with post-operative histopathological examination and immunohistochemical analysis of PSMA expression.[2]
A pilot study published in 2021 reported initial clinical experience with [99mTc]Tc-PSMA-T4 in patients with prostate cancer.[3] The study authors noted that PSMA-based imaging using PET/CT has revolutionised prostate cancer imaging, with main indications including staging of high-risk patients and evaluation of biochemical failure after treatment.[4]
The available sources do not report specific side effects of PSMA-T4. The completed phase 4 trial evaluated the safety of [99mTc]Tc-PSMA-T4, but the registry record does not list adverse event results.[1] As with all radiopharmaceuticals, the injected radioactivity is a consideration, but no specific safety findings are reported in the provided sources.
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