Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Prospective Study of Added Value of Florastamin (18F) PET/CT in Localisation of Clinically Significant Prostate Cancer in Patients with PI- Report of Multi-Parametric MRI, Elevated Serum PSA Levels and/or PSA Density and with Clinical Suspicion of Prostate Cancer

This study is investigating a new imaging scan called Prostavue to help find prostate cancer. It's for men who, based on blood tests (PSA levels) or other scans (like MRI), might have prostate cancer. The main goal is to see how effectively Prostavue locates significant prostate cancer. Researchers will also check if Prostavue changes how doctors think about a diagnosis or what treatment they recommend. The study will also look at any side effects from the Prostavue scan. This is a Phase III study, meaning it's one of the final steps to see if Prostavue is a useful and safe tool for doctors.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Curium Austria GmbH

Enrolment target

Start

12 Aug 2024

Prostate cancer

What is this study about?

This study is about making it easier and more accurate to find prostate cancer, especially in its early stages. Prostate cancer is a common cancer in men, and finding it at the right time is important for good treatment. Currently, doctors use things like blood tests (to check PSA levels) and MRI scans to get an idea if someone might have prostate cancer.

This new study is looking at a special type of scan called Prostavue (18F) PET/CT. It's designed to help doctors get a clearer picture of where the cancer might be in the prostate. This could be really helpful for men who have blood test results or MRI scans that suggest they might have prostate cancer, but doctors need more precise information.

The main aim is to see how accurate Prostavue is at pinpointing where the prostate cancer is. The study also wants to find out if using Prostavue helps doctors make better decisions about diagnosis and treatment. For example, will it help them decide if a biopsy is needed, or what type of treatment would be most effective? They will also be checking for any side effects from the Prostavue scan.

Key takeaways

This study is testing a new scan called Prostavue for prostate cancer.
It aims to find prostate cancer more accurately in men with suspicious test results.
The study will see if Prostavue helps doctors decide on the best treatment.
It's for men aged 18 and over who may have prostate cancer.
You will have a special scan and be monitored for any effects.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for men who are 18 years old or older. There is no upper age limit, meaning men of all adult ages can potentially take part.

To be considered for this study, you would likely have had previous tests that suggest you might have prostate cancer. This could include having higher than usual levels of a substance called PSA in your blood, or having results from an MRI scan that raise concerns.

Essentially, if your doctor suspects you might have prostate cancer based on your current health information, you might be a good fit for this study.

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 male?
Are you 18 years old or older?
Have you had unusual PSA blood test results?
Have you had an MRI scan that raised concerns about prostate cancer?
Does your doctor currently suspect you might have prostate cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo a special type of scan called Prostavue PET/CT. This scan involves a small amount of a special substance called Florastamin (18F) being put into your body. This substance helps the scan highlight any areas of prostate cancer.

Researchers will observe you for up to 24 hours after the scan to check for any immediate side effects. The study will likely involve follow-up appointments to see how your diagnosis and treatment decisions are affected by the Prostavue scan results. The total duration of your participation will depend on the study's specific plan, but it's designed to see the short and long-term impact of this new imaging technique.

Potential risks and benefits

Participating in this study might offer the benefit of potentially getting a more accurate diagnosis of prostate cancer, which could lead to a more tailored treatment plan. However, like any medical test, there are potential risks, such as very rare side effects from the imaging agent used in the Prostavue scan. The research team will carefully monitor you for any such effects. You are free to withdraw from 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
Austria

Common questions

What is prostate cancer?

Prostate cancer is a type of cancer that develops in the prostate, a small gland in men that helps make semen. It's common, especially in older men.

What is a 'PET/CT' scan?

PET/CT stands for Positron Emission Tomography / Computed Tomography. It's a powerful imaging scan that combines two different types of scans to get very detailed pictures inside your body, helping doctors find problems like cancer.

What is PSA?

PSA stands for Prostate-Specific Antigen. It's a protein produced by the prostate gland. High levels in the blood can sometimes, but not always, suggest prostate cancer or other prostate issues.

Will this scan replace my current diagnosis methods?

This study is investigating if Prostavue can help improve current diagnosis methods. It's not designed to replace existing tests but to see if it can add valuable information to help doctors make better decisions.

Are there any side effects from the Prostavue scan?

The study will be carefully monitoring for any side effects from the special substance used in the Prostavue scan, particularly in the first 24 hours. The research team will explain all known potential risks before you decide to participate.