RecruitingOBSERVATIONAL

The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients with Biochemical Failure Status Post Salvage or Radical Radiation Therapy

This research study is investigating prostate cancer, specifically looking at how two gene changes, called TMPRSS2-ERG and PTEN, might help predict how a man's cancer will respond to hormone therapy. We're focusing on men whose prostate cancer has started to grow again after having surgery or radiotherapy, and who are now receiving their first hormone treatment. The main goal is to see if these gene changes can indicate whether the hormone treatment will be successful for longer, or if the cancer might progress more quickly. Understanding this could help doctors make more informed treatment decisions in the future for men with high-risk prostate cancer.

At a glance

Status

Recruiting

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrolment target

208

Start

01 Mar 2016

Estimated completion

01 Mar 2027

Prostate Cancer

What is this study about?

This research study is about trying to understand prostate cancer better, especially in men who have already had treatment like surgery or radiotherapy, but whose cancer has shown signs of growing again – often indicated by a rising PSA level. At this point, doctors usually recommend a type of hormone treatment to help control the cancer.

Researchers are particularly interested in two specific changes that can happen in the genes of prostate cancer cells, called TMPRSS2-ERG and PTEN. The aim is to see if having these particular gene changes can help predict how well a man's cancer will respond to the hormone treatment. For example, will the treatment keep the cancer under control for a long time, or will the cancer start to grow again more quickly?

By figuring out this connection, doctors might one day be able to use information about these specific gene changes to help decide the best treatment plan for individual men, making treatment more personalised and potentially more effective.

Key takeaways

Aims to understand how specific gene changes impact prostate cancer treatment.
Focuses on men whose cancer has returned after initial treatment.
Participants will receive standard hormone therapy.
Hopes to predict treatment response based on gene changes.
Results could lead to more personalised prostate cancer care in the future.

Who may be eligible?

This study is looking for men aged 18 or older who have prostate cancer.

To be considered for this study, your prostate cancer needs to meet certain criteria, such as being at a more advanced stage, having a PSA level above 20, and a Gleason score of 8 or higher. These are medical terms your doctor can explain, but they generally refer to features of prostate cancer that suggest it is more aggressive or extensive. You also need to be well enough to take part in a study, which doctors measure using something called a Karnofsky score.

All participants must also agree to take part by signing an informed consent form. The study is specifically for men, and there are no known exclusion criteria mentioned beyond the general health and cancer characteristics that would make you unsuitable.

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 aged 18 or older?
Do you have prostate cancer that your doctor has identified as T3a or higher?
Is your PSA level above 20?
Do you have a Gleason score of 8 or higher?
Are you well enough for daily activities, as assessed by a doctor (Karnofsky score 70 or higher)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive standard hormone treatment for your prostate cancer, as your doctor would normally prescribe. The study will mainly follow your health over time, observing how your body responds to the treatment. This will include regular checks of your PSA levels. Even if your PSA levels start to rise, you will continue with your hormone treatment, though your doctor might consider adding other treatments or radiotherapy if deemed necessary for any small growths that spread (oligometastasis). The main part of your involvement is allowing researchers to collect information from your treatment journey for up to three years to see how your specific gene changes relate to your response.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps the medical community understand prostate cancer better, which could lead to better treatments for future patients. While there isn't a direct personal benefit expected from receiving new or experimental treatment in this study (as you'll be on standard care), understanding your specific gene changes might, in the future, help guide your own treatment journey. As you will be on standard treatment, the risks are generally those associated with the usual treatments for prostate cancer. You are free to withdraw from the study at any time without affecting your medical care.

Locations (9)

CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi
Verified postcode
Chicoutimi, Canada· Recruiting
CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne
Verified postcode
Greenfield Park, Canada· Recruiting
CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval
Verified postcode
Laval, Canada· Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
Verified postcode
Montreal, Canada· Recruiting
Jewish General Hospital, McGill University
Verified postcode
Montreal, Canada· Recruiting
MUHC - Cedars Cancer Center
Verified postcode
Montreal, Canada· Recruiting
CHU - L'Hôtel-Dieu de Québec
Verified postcode
Québec, Canada· Recruiting
CIUSSS de l'Estrie - Hôpital Fleurimont
Verified postcode
Sherbrooke, Canada· Not yet recruiting
CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières
Verified postcode
Trois-Rivières, Canada· Recruiting

Common questions

What are gene changes and why are they important?

Gene changes are tiny alterations in the building blocks of our cells. In cancer, these changes can affect how the cancer grows and responds to treatment. Understanding them helps doctors find better ways to treat the disease.

What is 'biochemical failure'?

This means your PSA levels, a marker in your blood for prostate cancer, have started to rise again after you've had initial treatment like surgery or radiotherapy. It suggests the cancer might be growing again.

What is LHRH agonist treatment?

This is a common type of hormone therapy for prostate cancer. It works by reducing the amount of male hormones in your body, which prostate cancer cells need to grow.

Will my treatment change if I join this study?

No, you will receive the standard hormone treatment that your doctor recommends. The study is about observing how you respond to this standard treatment based on your gene changes.

How long will I be followed in this study?

Researchers will follow your progress and treatment for up to three years to see how your prostate cancer responds over time.

How to find out more

Ashley Feng, M.Sc.

yanqi.feng.ccomtl@ssss.gouv.qc.ca 514-340-8222 Official trial record

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