Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05847166
Brief Summary:
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.
Detailed Description:
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:
NCT05847166
Study Brief:
Protocol Section:
NCT05847166