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 (60 for cohorts A, B and 20 for cohort C). Cohort A - lymph node assessment in intermediate risk group before the initiation of treatment. The patients will undergo \[99mTc\]Tc-PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol), and chest, and abdominal CE computed tomography and technetium-99m-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 \[99mTc\]Tc-PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol), and chest, and abdominal CE computed tomography and technetium-99m-MDP bone scan in unfavorable risk prostate cancer patients. Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery) The patients will undergo \[99mTc\]Tc-PSMA-T4 multi-SPECT/CT as an additional modality to 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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
\[99mTc\]Tc-PSMA-T4 for intravenous administration. The investigational medicinal product is to be prepared directly in a clinic by radiolabeling the radiopharmaceutical kit containing PSMA-T4 as a drug substance with sodium pertechnetate (99mTc) injection. The \[99mTc\]Tc-PSMA-T4 radiopharmaceutical should be used for targeted radionuclide SPECT imaging in patients with tumors and metastases of prostate cancer. The investigational medicinal product \[99mTc\]Tc-PSMA-T4 is dedicated for intravenous administration in radioactivity dose (555 - 740 MBq in cohorts A, B, C.
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Poland, Poland
RECRUITINGCentralny Szpital Kliniczny Uniwersytetu Medycznego
Lodz, Poland, Poland
RECRUITINGGAMMED Centrum Diagnostyczno-Lecznicze
Warsaw, Poland, Poland
RECRUITINGPrimary Endpoints
Clinical feasibility in each cohort: the diagnostic method will be deemed a feasible approach if at least 80% of participants in each cohort fulfil the criteria of sensitivity (true positive) and specificity (true negative) of PSMA-T4 WB-SPECT/CT - detection all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation by international guidelines for prostate cancer diagnosis and treatment ("golden standards" separate for each cohort). Feasibility = (number of patients with true positive and/or true negative without false positive and/or false negative results of PSMA-T4 WB-SPECT/CT x 100%) / all patients. The patients will undergo PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and\[ 99m Tc\]Tc-MDP bone scan in unfavorable risk prostate cancer patients.
Time frame: 17 weeks
Secondary Outcome Measures
Sensitivity(number of true positives x 100%)/(number of true positives + number of false negatives) Specificity:(number of true negatives x 100%)/(number of true negatives + number of false positives) Positive and negative predictive value: Positive predictive value defined as number of true positives x 100%/number of true positives + number of false positives. Negative predictive value defined as number of true negatives x 100%/number of true negatives + number of false negatives. The patients will undergo PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and\[ 99m Tc\]Tc-MDP bone scan in unfavorable risk prostate cancer patients.
Time frame: 17 weeks
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4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Poland, Poland
COMPLETED