AuthorisedPhase II and Phase III (Integrated)Interventional

An open-label phase 2/3 study to analyse the feasibility and evaluate the safety of intravenous administration of 99mTc-PSMA-T4 in patients with prostate cancer

This research study is looking at a new technique that uses a special substance called 99mTc-PSMA-T4, given through a drip into your vein, to help diagnose and plan treatment for prostate cancer. Researchers are trying to find out if this method is safe and effective. They want to see if it can accurately find cancer spots within the body when used with a type of scan called SPECT/CT. The study is particularly interested in whether this new approach can detect all the areas of cancer that have already been confirmed by other tests. This will help doctors understand if this new tool can be a reliable way to get a clear picture of a patient's prostate cancer.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Narodowe Centrum Badan Jadrowych

Enrolment target

Start

29 Jan 2025

Feasibility analysis and safety evaluation of [99mTc]Tc-PSMA-T4 in prostate cancer diagnosis and treatment planning.

What is this study about?

Imagine you have prostate cancer, and doctors need to know exactly where the cancer is and how much there is to plan the best treatment. This research study is testing a new way to do just that, using a special substance called 99mTc-PSMA-T4. It's like a tiny, clever detective that's given to you through a drip in your arm.

This detective substance then travels through your body and attaches itself to prostate cancer cells, making them light up on a special type of scan called a SPECT/CT scan. By doing this, doctors can get a much clearer picture of where the cancer is located. The main goal of this study is to see if this new method is both safe for patients and good at finding all the cancer spots that other tests have already seen.

Think of it as trying a new type of map to find hidden treasure. We know there's treasure (the cancer), and we want to see if this new map (the 99mTc-PSMA-T4 and SPECT/CT scan) is accurate and reliable for everyone. By taking part, you could help doctors learn if this new diagnostic tool can improve how prostate cancer is found and treated in the future.

Key takeaways

This study is testing a new way to find prostate cancer.
It uses a special substance and a SPECT/CT scan.
The main goals are to check safety and how accurately it detects cancer.
Participation involves an injection and scans, with short-term monitoring.
It's for men diagnosed with prostate cancer, aged 18 and over.

Who may be eligible?

This study is for men who have prostate cancer. To be considered, you must be at least 18 years old.

The research team will review your specific medical history and current health to determine if this study is suitable for you. They will check if your current health condition and any other treatments you're receiving fit with the study's requirements.

It's important to discuss with your doctor if this study might be a good option for you, and to understand all the details before making a decision.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Do you have prostate cancer?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll receive is the investigational substance, 99mTc-PSMA-T4, given through an injection into a vein (like a drip). After you receive the injection, you will undergo SPECT/CT scans. Researchers will be closely monitoring you for about 24 hours after the injection to check for any side effects. They'll also follow up for up to 48 hours to make sure you're doing well. The total duration of your active participation in this study will be quite short, mainly focused around the day of the injection and scans.

Potential risks and benefits

Potential benefits of participating in this study include gaining more detailed information about your prostate cancer through this new scanning method, which might help inform your treatment plan. However, there's no guarantee of direct personal benefit from taking part. Potential risks include side effects from the injected substance, though researchers will closely monitor you. You will be monitored for 24-48 hours after the injection for any reactions. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is 99mTc-PSMA-T4?

It's a special substance given through a drip that helps make prostate cancer cells visible on a scan.

What is a SPECT/CT scan?

It's a type of scan that uses the special substance to create detailed images of where cancer cells might be in your body.

Will this study cure my cancer?

This study is for diagnosis and treatment planning, not a cure. It helps doctors get a better picture of your cancer.

How long will I be involved in the study?

Your main involvement, including the injection and scans, will typically be within a 24 to 48-hour period.

Are there any side effects?

Researchers will be carefully watching for any side effects for up to 48 hours after the injection to ensure your safety.