Prostate Cancer Clinical Trial
Official title:
A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects With Prostate Cancer
The objectives of this study are to evaluate the feasibility and safety of [99mTc]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer.
This is a Phase 2/3, open-label study, with multicohort design that will enroll up to approximately 80 subjects with prostate cancer (40 for cohort A, 20 for cohorts B and C). Cohort A - lymph node assessment in intermediate risk group The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients. Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan). Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery) The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease). ;
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