RecruitingNot ApplicableNCT05847166

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

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

Sponsor

NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

Enrollment

80 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called PSMA-T4 for prostate cancer. It uses radioactive molecules that seek out prostate cancer cells (via PSMA, a protein found on prostate cancer) and destroy them from the inside — a targeted form of radiation therapy. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of prostate cancer with a Gleason score above 6 (an indicator of cancer aggressiveness) - You have had a confirmatory biopsy within the past 12 weeks - You are in good overall health **You may NOT be eligible if...** - You have received prior radiation therapy to the prostate area - You have serious heart, kidney, or liver conditions - You are currently taking medications that could interfere with the study treatment - You have another active cancer - Your cancer does not express the PSMA protein (as confirmed by imaging) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.