PSMA-T4 for Prostate cancer

Inclusion criteria

• {"criterion_text":"- 18 years of age or older.\n- PS ECOG < 2\n- Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.\n- 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.\n- Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B\n- Willingness to participate in this study and to provide written informed consent.\n- Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. (Cohort A)\n- 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. (Cohort A)\n- CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. (Cohort A)\n- No prior treatment for prostate cancer. (Cohort A)\n- High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. (Cohort B)\n- CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. (Cohort B)\n- No prior treatment for prostate cancer. (Cohort B)\n- Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases. (Cohort C)"}

Exclusion criteria

• {"criterion_text":"- No histopathological confirmation of prostate cancer.\n- Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.\n- 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.\n- Renal impairment including eGFR <30 ml / min.\n- 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.\n- Prior early or locally advanced malignancy after definitive treatment with at least 5-year period without evidence of disease.\n- Malignancy with distant metastases.\n- Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.\n- 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."}

Primary endpoints

• {"endpoint_text":"- The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.","definition_or_measurement_approach":"Feasibility defined as at least 80% of subjects in each cohort meeting criteria of sensitivity and specificity (cohorts A and B only) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions pathologically or radiologically confirmed or suspicious in other recommended modalities."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- Safety: Frequency of adverse events (AEs). The procedure-related AEs will be recorded during the 24h of the follow-up period in each case, no later than 48h after drug administration.\n- Dosimetry\n- Feasibility","definition_or_measurement_approach":"Positive predictive value and negative predictive value calculated as defined in the endpoint text. Safety measured by frequency of AEs; procedure-related AEs recorded during 24h follow-up (no later than 48h post administration). Dosimetry and feasibility assessed as described in protocol."}

Poland

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

457

Number Of Sites

3

Number Of Participants

80

Primary sponsor

Full Name

Narodowe Centrum Badan Jadrowych

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Genelytica Sp. z o.o.","duties_or_roles":"Codes: 1,10,11,12,14,5,6,7,8","organisation_type":"Pharmaceutical company"}