A Phase 2/3,PSMA-T4, Prostate Cancer
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. PS ECOG < 2 Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6. Confirmatory prostate biopsy, pelvic MRI and bone scan within 1 month before screening Willingness to participate in this study and to obtain written informed consent. Additional inclusion criteria for each cohort: Cohort A: Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer 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 B: 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 C: 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. Exclusion Criteria: No histopathological confirmation of prostate cancer. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. Infection with hepatitis B virus (including carriers) during screening, i.e. hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV) antibody. Infected with acquired immunodeficiency (HIV). 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 2xULN. Renal impairment including GFR <30 ml / min. Within 6 months before inclusion into the study: myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.); Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. Cerebrovascular accident, transient ischemic attack, acute stroke etc. Subjects with pulmonary embolism or deep vein thrombosis have been reported within the last 6 months. An active infection that the investigator considers precluding the patient from being included in the study, such as urinary tract infections, respiratory tract infections, and diabetes infection within the diabetic foot with osteomyelitis.
Sites / Locations
- GAMMED Centrum Diagnostyczno-LeczniczeRecruiting
- Centrum Onkologii im. prof. F. ŁukaszczykaRecruiting
- 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Cohort A - lymph node assessment in intermediate risk group
Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)
The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients
The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan).
The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and 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).