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Trial Title:
A Phase 2/3,PSMA-T4, Prostate Cancer
NCT ID:
NCT05847166
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The expected duration of participation for each subject is approximately 17 weeks. This
includes up to 1 week for screening, 4 weeks for diagnostic procedures, and 12 weeks for
safety evaluation.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
[99mTc]Tc-PSMA-T4
Description:
[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.
Arm group label:
Cohort A - lymph node assessment in intermediate risk group
Arm group label:
Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
Arm group label:
Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)
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 (40 for cohort A, 20 for cohorts B and C).
Cohort A - lymph node assessment in intermediate risk group 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. Cohort B - general assessment (bone and lymph nodes) in high and very
high-risk group 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). Cohort C -
recurrent disease after definitive treatment (radiotherapy or surgery) 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).
Criteria for eligibility:
Criteria:
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, pelvic MRI and bone scan within 1 month before
screening
5. Willingness to participate in this study and to obtain 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.
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:
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. Infection with hepatitis B virus (including carriers) during screening, i.e.
hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV)
antibody.
4. Infected with acquired immunodeficiency (HIV).
5. 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.
6. Renal impairment including GFR <30 ml / min.
7. Within 6 months before inclusion into the study: myocardial infarction or other
cardiac events requiring hospitalization (unstable angina, etc.);
8. Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia),
second or higher degree atrio-ventricular (AV) heart block.
9. Cerebrovascular accident, transient ischemic attack, acute stroke etc.
10. Subjects with pulmonary embolism or deep vein thrombosis have been reported within
the last 6 months.
11. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GAMMED Centrum Diagnostyczno-Lecznicze
Address:
City:
Warszawa
Zip:
02-351
Country:
Poland
Status:
Recruiting
Contact:
Last name:
GENELYTICA
Phone:
513466270
Email:
k.socko@genelytica.com
Investigator:
Last name:
Jarosław Ćwikła, Prof.
Email:
Principal Investigator
Facility:
Name:
Centrum Onkologii im. prof. F. Łukaszczyka
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
GENELYTICA
Phone:
513466270
Email:
k.socko@genelytica.com
Investigator:
Last name:
Bogdan Małkowski, Prof
Email:
Principal Investigator
Investigator:
Last name:
Marta Maruszak-Parada, Dr
Email:
Sub-Investigator
Facility:
Name:
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Address:
City:
Wrocław
Zip:
53-114
Country:
Poland
Status:
Recruiting
Contact:
Last name:
GENELYTICA
Phone:
513466270
Email:
k.socko@genelytica.com
Investigator:
Last name:
Andrzej Kołodziejczyk, Dr
Email:
Principal Investigator
Start date:
May 10, 2023
Completion date:
December 28, 2024
Lead sponsor:
Agency:
NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom
Agency class:
Industry
Source:
NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05847166
