A Phase 2/3,PSMA-T4, Prostate Cancer

NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: [99mTc]Tc-PSMA-T4

Study type: Interventional

Funder types: Industry

Identifiers

NCT05847166

PSMA-T4_2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Cohort A - lymph node assessment in intermediate risk group

Active Comparator group

Description:

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

Treatment:

Radiation: [99mTc]Tc-PSMA-T4

Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group

Active Comparator group

Description:

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).

Treatment:

Radiation: [99mTc]Tc-PSMA-T4

Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)

Active Comparator group

Description:

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).

Treatment:

Radiation: [99mTc]Tc-PSMA-T4