Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-05-10
2025-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort A - lymph node assessment in intermediate 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.
[99mTc]Tc-PSMA-T4
\[99mTc\]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.
Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
The patients will undergo \[99mTc\]TcPSMA-T4 multi-SPECT/CT as an additional modality to CE multiparametric MRI (according to PI-RADS 2.1 protocol), chest, abdomen CE computed tomography, and skeletal scintigraphy (technetium-99m-MDP bone scan).
[99mTc]Tc-PSMA-T4
\[99mTc\]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.
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).
[99mTc]Tc-PSMA-T4
\[99mTc\]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.
Interventions
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[99mTc]Tc-PSMA-T4
\[99mTc\]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.
Eligibility Criteria
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Inclusion Criteria
2. PS ECOG \< 2
3. Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.
4. Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B.
5. Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B.
6. Willingness to participate in this study and to provide written informed consent.
Cohort A:
1. Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer
2. Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients.
3. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.
4. No prior treatment for prostate cancer.
Cohort B:
1. High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer
2. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.
3. No prior treatment for prostate cancer.
Cohort C:
Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA) OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases (Roach et al.., 2006).
Exclusion Criteria
2. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.
3. Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN.
4. Renal impairment including eGFR \<30 ml / min.
5. Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis
6. Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.
7. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis osteomyelitis.
18 Years
MALE
No
Sponsors
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NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Garnuszek, Sponsor
Role: STUDY_DIRECTOR
NCBJ Polatom
Locations
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Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Poland, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego
Lodz, Poland, Poland
GAMMED Centrum Diagnostyczno-Lecznicze
Warsaw, Poland, Poland
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Poland, Poland
Countries
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Central Contacts
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Facility Contacts
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Bogdan Małkowski, Prof
Role: backup
Marta Maruszak-Parada, Dr
Role: backup
Zbigniew Adamczewski, Prof.
Role: backup
Jarosław Ćwikła, Prof.
Role: backup
Other Identifiers
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PSMA-T4_2021
Identifier Type: -
Identifier Source: org_study_id
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