RecruitingNAINTERVENTIONAL

Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

This study, called PREOP-PSMA, is investigating a special type of scan called PSMA PET/CT for men with prostate cancer. In the UK, prostate cancer is a common illness in men. Before surgery, doctors need to know if the cancer has spread to nearby lymph nodes, which are small glands that are part of your immune system. Currently, standard scans aren't always great at showing this. The PSMA PET/CT scan uses a special dye that sticks to prostate cancer cells, making them show up more clearly. Researchers hope this scan will give doctors a much better picture of where the cancer is, helping them plan the best individual treatment, often surgery, and ultimately improve men's outcomes and reduce the chance of the cancer coming back.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Brest

Enrolment target

159

Start

20 May 2021

Estimated completion

20 May 2027

Prostate Cancer

What is this study about?

This study, known as PREOP-PSMA, is focusing on prostate cancer, a common cancer affecting men. When a man is diagnosed with prostate cancer, doctors need to understand how much the cancer has grown and if it has spread beyond the prostate gland. This is very important for planning the right treatment, which for some men might be surgery to remove the prostate. Doctors pay close attention to whether cancer cells have reached nearby lymph nodes.

Currently, doctors use standard scans, like MRI scans, to look for signs of spread. However, these scans aren't always perfect at spotting cancer in the lymph nodes. This can make it harder to be completely sure about the extent of the cancer before surgery. This study is exploring a newer, more advanced type of scan called PSMA PET/CT. This scan uses a special substance that attaches itself to prostate cancer cells, making them light up on the scan. The idea is that this could give doctors a much clearer and more accurate picture of whether the cancer has spread to the lymph nodes.

By getting a clearer picture, doctors can make more informed decisions about treatment. For example, if they know the cancer has spread to certain lymph nodes, they might adjust the surgery or recommend other treatments alongside it. The goal is to provide each man with the best possible personalised care, and ultimately reduce the chance of the cancer returning after treatment.

Key takeaways

The study is about a new scan (PSMA PET/CT) for prostate cancer.
It aims to improve how doctors check for cancer spread to lymph nodes before surgery.
This could help doctors plan more precise, personalised treatments.
The scan uses a special tracer that highlights cancer cells.
It's for men with intermediate or high-risk prostate cancer having surgery.
Findings could lead to better outcomes for prostate cancer patients.

Who may be eligible?

To join this study, you would need to be a man with prostate cancer that has been confirmed by a biopsy. Your doctors would have classified your cancer as 'intermediate-risk' or 'high-risk,' meaning it has certain features that suggest it might be more aggressive or likely to spread. A key requirement is that your medical team has decided that the best treatment for you is surgery to remove your prostate gland.

You would not be able to join the study if you have 'low-risk' prostate cancer, or if your intermediate-risk cancer has a very low chance of spreading to lymph nodes. Also, if your doctors have chosen a different main treatment for you, other than surgery, you wouldn't be suitable. Other reasons not to join include if you're too unwell to participate, if you have a very short life expectancy for other reasons, or if you can't or don't want to be in the 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.

Have you been diagnosed with prostate cancer confirmed by biopsy?
Has your doctor told you your prostate cancer is 'intermediate-risk' or 'high-risk'?
Have your doctors decided that surgery to remove your prostate is the main treatment plan for you?
Are you generally well enough to participate in a study?
Are you over 18 years old?

Answer every question to see your result.

What does participation involve?

The information provided doesn't go into specific details about what taking part would involve in terms of visits, assessments, or follow-up duration. However, generally, if you were to participate in a study like this, you would likely have the PSMA PET/CT scan, probably in addition to your standard scans. You would also continue with your planned prostate cancer surgery. Researchers would then compare the results of the PSMA PET/CT scan with what is found during your surgery to see how accurate the new scan is. This study does not mention any new medications you would take. The overall duration isn't specified, but it would involve undergoing the scan before your surgery and potentially follow-up to see your treatment outcome.

Potential risks and benefits

Potential benefits of taking part could include gaining access to an advanced scan that might give your doctors a more detailed understanding of your cancer than standard tests alone. This extra information could help ensure your treatment plan is as accurate and effective as possible. Potential risks would be similar to those of any medical scan, such as exposure to a small amount of radiation from the PET/CT scan and potential reactions to the special dye used (though these are rare). As with any clinical study, you would always have the right to withdraw at any time without it affecting your medical care.

Locations (1)

CHRU de Brest
Verified postcode
Brest, France· Recruiting

Common questions

What is PSMA PET/CT?

It's a special type of scan that uses a small amount of a radioactive tracer that sticks to prostate cancer cells, making them visible on the scan. It helps doctors see if cancer has spread.

Why is this scan important for prostate cancer?

It can help doctors see more clearly if prostate cancer has spread to nearby lymph nodes before surgery. This information is key for planning the best treatment.

Will I still have my surgery if I join this study?

Yes, a core requirement to join is that your medical team has already decided that surgery to remove your prostate is the best treatment option for you.

Is this scan available everywhere?

PSMA PET/CT is a newer imaging technique. While it's becoming more common, its availability can vary, and it might not be a standard scan offered in all clinics or hospitals.

What if my existing scans are clear?

This study aims to see if the PSMA PET/CT scan provides additional, more accurate information, even when standard scans might not show clear signs of spread to lymph nodes.

How to find out more

Philippe ROBIN

philippe.robin@chu-brest.fr +33298223327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.