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

NCT05847166 | Recruiting

• 1 other identifier: PSMA-T4_2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints

  Clinical feasibility in each cohort: the diagnostic method will be deemed a feasible approach if at least 80% of participants in each cohort fulfil the criteria of sensitivity (true positive) and specificity (true negative) of PSMA-T4 WB-SPECT/CT - detection all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation by international guidelines for prostate cancer diagnosis and treatment ("golden standards" separate for each cohort). Feasibility = (number of patients with true positive and/or true negative without false positive and/or false negative results of PSMA-T4 WB-SPECT/CT x 100%) / all patients. The patients will undergo PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and\[ 99m Tc\]Tc-MDP bone scan in unfavorable risk prostate cancer patients.

  17 weeks

Secondary Outcomes (1)

• Secondary Outcome Measures

  17 weeks

Study Arms (3)

Cohort A - lymph node assessment in intermediate risk group

ACTIVE COMPARATOR

The patients will undergo \[99mTc\]Tc-PSMA-T4 multi-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol), and chest, and abdominal CE computed tomography and technetium-99m-MDP bone scan in unfavorable risk prostate cancer patients.

Radiation: [99mTc]Tc-PSMA-T4

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

ACTIVE COMPARATOR

The patients will undergo \[99mTc\]TcPSMA-T4 multi-SPECT/CT as an additional modality to CE multiparametric MRI (according to PI-RADS 2.1 protocol), chest, abdomen CE computed tomography, and skeletal scintigraphy (technetium-99m-MDP bone scan).

Radiation: [99mTc]Tc-PSMA-T4

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

ACTIVE COMPARATOR

The patients will undergo \[99mTc\]Tc-PSMA-T4 multi-SPECT/CT as an additional modality to 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).

Radiation: [99mTc]Tc-PSMA-T4

Interventions

[99mTc]Tc-PSMA-T4 RADIATION

\[99mTc\]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.

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B.
• Willingness to participate in this study and to provide written informed consent.
• 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.
• CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.
• No prior treatment for prostate cancer.
• 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
• CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.
• No prior treatment for prostate cancer.

You may not qualify if:

• No histopathological confirmation of prostate cancer.
• Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.
• 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.
• Renal impairment including eGFR \<30 ml / min.
• Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.
• 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.

Sponsors & Collaborators

• NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom: lead

Study Sites (4)

Centrum Onkologii im. prof. F. Łukaszczyka

Bydgoszcz, Poland, 85-796, Poland

RECRUITING

Centralny Szpital Kliniczny Uniwersytetu Medycznego

Lodz, Poland, 92-216, Poland

RECRUITING

GAMMED Centrum Diagnostyczno-Lecznicze

Warsaw, Poland, 02-351, Poland

RECRUITING

4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, Poland, 53-114, Poland

COMPLETED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Piotr Garnuszek, Sponsor

  NCBJ Polatom

  STUDY DIRECTOR

Central Study Contacts

Piotr Garnuszek, Sponsor

CONTACT

+48 22 273 1700; Piotr.Garnuszek@polatom.pl

Katarzyna Socko, CRO

CONTACT

k.socko@genelytica.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: May 6, 2023
• Study Start: May 10, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2024
• Access Criteria: After contact and approval of the Sponsor

Locations

PL (4)