RecruitingOBSERVATIONAL

The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.

The GENPET study is looking for a better way to find out if prostate cancer has spread in men who have certain inherited gene changes. These gene changes, like BRCA, can sometimes make prostate cancer more likely to spread. We're comparing common scans, like MRI and bone scans, with a newer type of scan called a PET-CT. The goal is to see if the PET-CT scan is more accurate in spotting if the cancer has travelled to other parts of the body, outside the pelvis, in these men. This could help doctors make more informed decisions about treatment.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

15 Oct 2015

Estimated completion

31 Dec 2032

Prostate Cancer BRCA Mutation Mismatch Repair Gene Mutation ATM Gene Mutation HOXB13 Germline Mutation CHEK2 Gene Mutation PALB2 Gene Mutation

What is this study about?

The GENPET study is designed to help improve how doctors check for prostate cancer spread, especially in men who carry certain inherited gene changes. Some men have changes in their DNA (genes) – such as BRCA or ATM – that fix damaged cells. When these genes don't work properly, it can increase the risk of prostate cancer, and sometimes make it more likely to spread to other areas of the body.

Currently, doctors use scans like MRI (Magnetic Resonance Imaging) and bone scans to see if prostate cancer has spread. This study is investigating if a different type of scan, called a PET-CT scan, could be more effective. A PET-CT scan combines two powerful imaging techniques to create detailed pictures inside your body. The study aims to see if this PET-CT scan is better at finding any cancer spread (metastases) outside the main prostate area compared to the standard scans.

The information gathered from this study could help doctors in the future choose the best scanning methods for men with prostate cancer who also have these specific gene changes. This means getting a clearer picture of whether the cancer has spread, which can then guide treatment decisions to give patients the best possible care.

Key takeaways

This study compares different scanning methods for prostate cancer.
It's for men with prostate cancer who also have specific inherited gene changes.
The goal is to see if PET-CT scans are better at finding if cancer has spread.
Participation involves having these scans as part of your medical care.
The findings could help doctors make better decisions about future prostate cancer care.

Who may be eligible?

This study is looking for men over 18 years old who have been diagnosed with prostate cancer and also have a confirmed inherited gene change in genes like BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, or ATM.

You might be suitable to take part if you are newly diagnosed with prostate cancer, or if your prostate cancer is starting to show signs of growing again after previous surgery or radiotherapy, and you are not currently having hormone therapy or chemotherapy. Also, if you are currently on 'active surveillance' (closely watching the cancer without immediate treatment) and your PSA blood levels are rising quickly, you could be eligible.

However, you cannot join if you have been diagnosed with another type of cancer in the last five years (unless it was a common skin cancer), or if your prostate cancer has already spread. You also can't take part if you've had cancer treatment in the past six months, are taking certain medications like steroids or experimental drugs, have long-term inflammatory conditions, or have any medical issues that prevent you from having an MRI scan (like a pacemaker).

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 over 18?
Do you have a confirmed inherited gene change like BRCA or ATM?
Do you have prostate cancer that needs new scans (e.g., newly diagnosed, or cancer returning)?
Have you NOT had other types of cancer in the last 5 years (except common skin cancer)?
Have you NOT had cancer treatment in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you join the study, you will likely have a PET-CT scan. This scan will be compared to your usual MRI and bone scans that are part of your standard care for prostate cancer. The study will mainly involve you having these scans as part of your normal treatment pathway. There isn't information provided about extra visits, specific medications from the study, or how long your participation would last beyond the imaging tests.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of a more detailed scan (PET-CT) to help understand your prostate cancer better, though its direct impact on your immediate treatment plan isn't specified. As with any medical procedure, there are potential risks associated with scans, such as exposure to a small amount of radiation from the PET-CT and bone scan, and potential reactions to the contrast dye used in some scans. You have the right 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.

Cancer Genetics Unit, Royal Marsden Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a gene mutation?

A gene mutation is a small change in your DNA instructions. Some can be inherited and might affect how your body deals with cell damage, potentially increasing cancer risk or affecting how it grows.

What is PET-CT?

PET-CT is a special scan that combines two types of imaging. It creates detailed pictures of your body, which can help doctors see if cancer has spread and where it might be.

Will I get any new medicine in this study?

No, this study is about comparing different types of scans, not testing new medications. You will continue to receive your usual medical care for prostate cancer.

Does this mean my prostate cancer is more serious?

Having a gene change doesn't automatically mean your cancer is more serious, but some changes can increase the chance of it spreading. This study aims to find the best way to check for that spread.

Can women take part in this study?

No, this study is specifically for men, as it focuses on prostate cancer.

How to find out more

Rosalind A Eeles, FRCP FRCR

rosalind.eeles@icr.ac.uk +44 208 722 4483 Official trial record

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