Study results announced for one-step radiopharmaceutical kit for prostate cancer imaging

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Radiopharmaceuticals company Theragnostics Ltd has announced the results of a phase I study evaluating the safety and biodistribution of 68Ga-THP-PSMA PET/CT in patients with prostate cancer

Fourteen patients with biopsy proven adenocarcinoma of the prostate took part in the study and were split into two groups. Group A included treatment naïve patients scheduled for surgery (prostatectomy). Group B observed patients with metastatic prostate cancer (represented by demonstration of at least one unequivocal PSMA-avid focus), and compared 68Ga-THP-PSMA PET/CT with standard of care, 68Ga-HBED-PSMA-11 PET/CT.

Results demonstrated that 68Ga-THP-PSMA can be safely administered, with no adverse events recorded in any patients. Uptake seen in the prostate on 68Ga-THP-PSMA PET/CT correlated with histopathologic PSMA expression seen on pathology finding following prostatectomy, highlighting the ability to non-invasively image prostate cancer directly. 

The results were published in The Journal of Nuclear Medicine.   

68Ga-PSMA positron emission tomography/computed tomography (PET/CT) is a noninvasive diagnostic technique to image prostate cancer with increased prostate-specific membrane antigen expression. PSMA is a transmembrane protein primarily present in all prostatic tissues. Increased PSMA expression is seen in a variety of malignancies, most notably in prostate cancer.

Adenocarcinomas of the prostate demonstrate PSMA expression in the majority of primary and metastatic lesions.2 68Ga-HBED-PSMA-11 PET/CT has demonstrated clinical utility in both staging of newly diagnosed patients and restaging. More accurate staging of high risk patients may enable better selection of the most appropriate management strategy and avoid futile locoregional surgery or radiotherapy in patients with metastatic disease. 68Ga-THP-PSMA PET/CT is a new radiopharmaceutical with a simplified design for an easy-to-use one-step-kit.

Associate Professor Michael Hofman, lead investigator of the study, said: “This is an important advance in order to make this new scan widely available to men with prostate cancer.”

Professor Prokar Dasgupta, Professor and Chair of Urology at King’s College London, Guy’s Hospital, King’s Health Partners comments, “PSMA PET scanning is fast becoming the imaging modality of choice in high-risk prostate cancer as well as in patients with recurrent disease. Accurate staging, particularly in patients with metastatic disease is absolutely vital.”