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).

Inclusion Criteria:

1. 18 years of age or older.
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.

Additional inclusion criteria for each cohort:

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:

1. No histopathological confirmation of prostate cancer.
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.

Clinical Study Report (CSR)

2024

After contact and approval of the Sponsor