Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection

This study is for men with prostate cancer who are having surgery to remove their prostate. Doctors are trying out a new technique during the operation to help them find very small cancer cells that might have spread to lymph nodes (tiny glands that are part of your immune system). They use special dyes that light up on a scan, which helps the surgeon see these tiny cancer cells more clearly, even if they're too small to see usually. The main goal is to see if this new method helps surgeons remove more of these hidden cancer cells, potentially offering a more complete treatment for prostate cancer. This is a Phase II study, meaning it's an earlier stage trial to see if the new method is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

100

Start

11 Nov 2024

Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data

What is this study about?

This research study is about finding better ways to treat prostate cancer, specifically when it might have started to spread. When men have prostate cancer surgery, doctors often remove some nearby lymph nodes – these are small, bean-shaped glands that are part of your body's immune system. Cancer cells can sometimes spread to these lymph nodes.

The challenge is that sometimes these cancer cells in the lymph nodes are very tiny and hard for the surgeon to see, even with advanced techniques. This study is testing if using a special fluid, called a 'tracer', given before or during surgery, can help highlight these tiny cancer cells. This tracer is designed to 'stick' to prostate cancer cells and show up on a special scanning device, much like a tiny light.

The aim is that by using this tracer, surgeons will be able to see and remove more of these hidden cancer cells during the operation. This could lead to a more thorough removal of the cancer, which might improve the long-term outlook for men with prostate cancer. This is a "Phase II" study, which means it's an earlier stage trial designed to see how well these new methods work and if they are safe.

Key takeaways

Aims to improve prostate cancer surgery.
Uses special scans and tracers to find hidden cancer cells.
For men having prostate removal surgery.
Hopes to offer more complete cancer removal.
It's a research study in its early stages (Phase II).

Who may be eligible?

This study is looking for men who have been diagnosed with prostate cancer and are planning to have surgery to remove their prostate. Specifically, it's for those whose doctors believe there's a chance (more than 5%) that the cancer may have spread to their lymph nodes, based on tests done before surgery.

To join, you need to be an adult male, meaning 18 years old or older. There is no upper age limit for taking part. Doctors will check all your medical information carefully to make sure this study is right for you and safe.

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 diagnosed with prostate cancer?
Are you planning to have surgery to remove your prostate?
Has your doctor told you there's a chance the cancer might have spread to lymph nodes?
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, you will likely have some extra steps related to your planned prostate cancer surgery. This includes potentially receiving a special tracer fluid, either as an injection before your surgery or directly during the operation. You might also have additional scans or tests compared to standard care, either before or after your surgery.

These procedures are designed to help doctors see the cancer cells better. After your surgery, the lymph nodes that are removed will be checked very closely by expert doctors. The results, particularly how many cancer cells were found, would typically be available about 10 days after your operation. The total duration of your active participation will revolve around your surgery and immediate follow-up appointments.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new technique helps your surgeon remove more of your cancer, which could improve your treatment. However, as with any medical procedure, there are potential risks associated with the special tracers used, such as allergic reactions, or risks linked to additional scans. All potential risks will be thoroughly explained to you by the study team. Remember, you can choose to withdraw from the study at any time without affecting your standard 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
Italy

Common questions

What are lymph nodes?

Lymph nodes are small glands that are part of your body's immune system, helping to fight off infections. Cancer cells can sometimes spread to them.

What does 'imaging guided surgery' mean?

It means using special scans or tracers during or just before surgery to help the surgeon see things in your body, like cancer cells, more clearly.

Will this change my main prostate cancer surgery?

No, you will still have your planned prostate removal surgery. This study adds a special step to help the surgeon during that operation.

What is a 'tracer' that they are using?

It's a special substance that can be seen on scans. In this study, it's designed to attach to prostate cancer cells, making them 'light up' for the surgeon.

Is this a new type of treatment?

It's a new technique to improve how surgeons find and remove cancer during an existing surgery, rather than a completely new drug treatment.