Evaluating a new imaging method for prostate cancer diagnosis and treatment planning

A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects With Prostate Cancer

This study is testing a new imaging method to see if it can help doctors better diagnose and plan treatment for men with prostate cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom (industry)
• Locations: 4 sites (Bydgoszcz, Poland and 3 other locations)
• Trial ID: NCT05847166 on ClinicalTrials.gov

What this trial studies

This study aims to assess the feasibility and safety of using [99mTc]Tc-PSMA-T4 in diagnosing and planning treatment for prostate cancer. It is an open-label, multicohort study enrolling approximately 80 subjects with prostate cancer, divided into three cohorts based on risk levels and treatment history. Patients will undergo multi-SPECT/CT imaging with [99mTc]Tc-PSMA-T4 alongside other imaging modalities to enhance diagnostic accuracy. The study will evaluate the effectiveness of this imaging technique in various clinical scenarios, including lymph node assessment and recurrent disease.

Who should consider this trial

Good fit: Ideal candidates include adult males aged 18 and older with a prior diagnosis of prostate cancer and specific risk profiles as defined by the study cohorts.

Not a fit: Patients with prostate cancer who do not meet the inclusion criteria, such as those with a Gleason score of 6 or lower, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer diagnosis and treatment planning, leading to better patient outcomes.

How similar studies have performed: Other studies have explored similar imaging techniques, but the specific use of [99mTc]Tc-PSMA-T4 in this context is relatively novel.

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 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.

Where this trial is running

Bydgoszcz, Poland and 3 other locations

• Centrum Onkologii im. prof. F. Łukaszczyka — Bydgoszcz, Poland, Poland (RECRUITING)
• Centralny Szpital Kliniczny Uniwersytetu Medycznego — Lodz, Poland, Poland (RECRUITING)
• GAMMED Centrum Diagnostyczno-Lecznicze — Warsaw, Poland, Poland (RECRUITING)
• 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ — Wroclaw, Poland, Poland (COMPLETED)

Study contacts

• Study coordinator: Piotr Garnuszek, Sponsor

Conditions: Prostate Cancer