RecruitingNAINTERVENTIONAL

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

Prostate cancer that has had surgery can sometimes come back. This study is testing a new way to give radiation therapy, called image-guided radiotherapy, for men whose prostate cancer has returned locally or regionally after a prostate removal operation. Researchers will use special scans, known as PSMA PET scans, to accurately find where the cancer is. This allows them to give a higher dose of radiation directly to the cancer and a lower dose to the surrounding healthy areas. The aim is to see if this method is safe and effective in treating the returning cancer while reducing side effects. Patients in the study will be followed up for up to five years after treatment to monitor their health.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

23 Aug 2022

Estimated completion

01 Aug 2030

Prostate Cancer

What is this study about?

This study is investigating a new and more precise way to deliver radiation therapy for men who have had prostate cancer that has returned after their initial surgery (radical prostatectomy). Sometimes, even after surgery, a small amount of cancer can remain or reappear in the local area or nearby lymph nodes. This is called biochemical failure or recurrence.

The main idea behind this study is to use very advanced imaging scans, specifically something called a PSMA PET scan, to get a crystal-clear picture of exactly where the cancer has returned. Once the cancer sites are precisely located, the radiation treatment can be tailored very carefully. This means the doctors can give a stronger dose of radiation directly to the areas where the cancer is, aiming to destroy it more effectively. At the same time, they can give a lower dose to the healthy tissues around the cancer, which helps to reduce potential side effects.

By targeting the radiation more accurately, the hope is to improve the chances of successfully treating the recurring cancer while also making the treatment easier to tolerate for patients. The study will carefully follow participants for up to five years to see how well this new approach works and to monitor their health over time. This research is important because it could lead to more effective and safer ways to treat prostate cancer that has come back.

Key takeaways

This study explores a new, precise radiation treatment for returning prostate cancer.
It uses special scans (PSMA PET) to guide radiation, targeting cancer more effectively.
The goal is to increase radiation to cancer while reducing it to healthy areas, potentially lowering side effects.
It's for men whose prostate cancer has come back locally or regionally after surgery.
Participants will have regular follow-ups for up to five years.
It's a Phase II study, meaning it's still in an early stage of testing.

Who may be eligible?

This study is looking for men over 18 who have had prostate cancer. You need to have already had surgery to remove your prostate, and now your prostate cancer has shown signs of coming back, but only in the local area or nearby lymph nodes. This return of cancer must be confirmed by a special scan called a PSMA PET scan, and you can't have too many affected lymph nodes (no more than five).

To be considered, you also need to be generally well and able to get around, as described by a score called ECOG 0-1, which means you can do most or all of your normal daily activities without much trouble.

However, you cannot join the study if your cancer has spread further in your body (like to distant parts or to specific lymph nodes called para-aortic lymph nodes). You also can't take part if you have a long-term inflammation in your pelvis, if you've already had radiation treatment in your pelvis before, or if there's a medical reason why radiation therapy isn't suitable for you.

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 years old?
Have you been diagnosed with prostate cancer that was treated with surgery (radical prostatectomy)?
Has your prostate cancer shown signs of coming back locally or nearby, as confirmed by a PSMA PET scan?
Do your scans show 5 or fewer affected lymph nodes?
Are you generally well and active (ECOG 0-1)?
Have you NOT had previous radiation treatment in your pelvis?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a specific type of radiation treatment tailored to your cancer based on your PSMA PET scans. The radiation will focus more intensely on the areas where the cancer has returned and less on healthy tissues. After your treatment, you will be followed up by your medical team, just as you would normally be after standard prostate cancer care. This will involve regular check-ups, blood tests, and scans over a period of up to five years to monitor your progress and overall health. The exact number and timing of visits will depend on your individual treatment plan and standard care guidelines.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more targeted and potentially effective radiation treatment for your prostate cancer, possibly with fewer side effects to surrounding healthy tissues. However, like all medical treatments, there are potential risks associated with radiation therapy, which your doctor will discuss with you in detail. These can include short-term side effects like fatigue or irritation, and rarely, more serious long-term effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a PSMA PET scan?

A PSMA PET scan is a special imaging test that helps doctors find prostate cancer cells more accurately by highlighting a particular protein found on their surface.

What does 'biochemical failure' mean?

Biochemical failure means that your blood test for PSA (prostate-specific antigen) has risen after surgery, suggesting that some prostate cancer might have returned.

What is 'image-guided radiotherapy'?

This is a very precise way of giving radiation treatment where doctors use detailed scans, like the PSMA PET, to target the radiation beam exactly where the cancer is, avoiding healthy organs.

Will I receive new medication in this study?

This study focuses on a specific type of radiation treatment. It doesn't involve new medications, but rather a new way of delivering existing radiation therapy.

How long will I be followed up after treatment?

You will be followed up for up to five years after your radiation treatment, which is part of routine care to monitor your health and the success of the treatment.

How to find out more

Andrew McPartlin, MD

andrew.mcpartlin@uhn.ca 416-946-4501 Official trial record

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