MedTrace Logo

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

NCT05847166 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

RADIATION

[99mTc]Tc-PSMA-T4

\[99mTc\]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.

Sponsors & Collaborators

  • NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

    lead INDUSTRY

Principal Investigators

  • Piotr Garnuszek, Sponsor · NCBJ Polatom

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05847166 on ClinicalTrials.gov