Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

This study is for men with prostate cancer that has spread to a few small areas in the body, but only shows up on a very sensitive scan called a PSMA PET scan, not on regular X-rays or MRI scans. We are trying to find out if combining a special type of focused radiotherapy, called SBRT, with standard hormone therapy works better than just using hormone therapy on its own. SBRT aims to target and treat all the small cancer spots identified. We hope this combination might lead to better results for patients. This is an early-stage study (Phase 1/2) to see if this approach is safe and promising.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

27 Oct 2020

Estimated completion

01 Oct 2027

Prostate Cancer

What is this study about?

This research study is looking at a new way to treat prostate cancer, specifically for men whose cancer has spread to a few small, separate areas in the body. This is often called 'oligometastatic' cancer. What's special about this study is that we are focusing on cancer that can only be seen with a very sensitive scan called a PSMA PET scan, and *not* with more common scans like CT or bone scans.

The main goal is to see if adding a treatment called Stereotactic Body Radiotherapy (SBRT) to standard hormone therapy works better than hormone therapy alone. SBRT is a highly accurate type of radiation treatment that delivers strong doses of radiation to specific cancer spots while trying to avoid healthy tissue. We want to know if carefully targeting and treating all these small cancer spots with SBRT, alongside hormone therapy, can improve how well patients do compared to just using hormone therapy, which aims to slow the cancer down throughout the body.

By taking part, you would be helping doctors understand if this more targeted approach could become a new standard treatment option for men with this specific type of prostate cancer. Your participation is really valuable in helping us learn more and potentially improve care for future patients.

Key takeaways

Tests if focused radiation (SBRT) plus hormone therapy is better than hormone therapy alone.
For men with prostate cancer that has spread slightly, only visible on special PSMA PET scans.
SBRT is a powerful, precise radiation treatment.
Aims to improve outcomes for this specific type of prostate cancer.
Participation helps advance understanding of prostate cancer treatment.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer. Your cancer must be hormone-sensitive, meaning it responds to hormone treatment, and it should have spread to only a few small areas in your body.

Crucially, these small cancer spots must only be visible on a special scan called a PSMA PET scan – they shouldn't show up on a regular CT scan, MRI, or bone scan. You can have a maximum of three such spots, and these spots must be in places that can be safely treated with the special focused radiation (SBRT).

There are also some reasons why you might not be able to join. For example, if you have other serious health problems that would make hormone therapy or SBRT unsafe, or if you've already had hormone therapy specifically to treat cancer that has spread. You also can't have a history of other cancers in the last five years (unless it was a mild skin cancer or a very early-stage cancer).

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 over 18 years old?
Do you have hormone-sensitive prostate cancer that has spread to only a few places?
Were your cancer spots only seen on a PSMA PET scan, not on regular scans?
Do you have no more than three such cancer spots?
Have you been told your general health is good enough for radiation and hormone therapy?

Answer every question to see your result.

What does participation involve?

Information about what taking part in this study involves isn't fully detailed in the summary. However, typically in studies like this, you would likely have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. If you are in the group receiving SBRT, you would undergo a series of focused radiation treatments, usually over a few days or weeks. All participants would receive hormone therapy. You would be closely monitored throughout the study, and there would be follow-up appointments after your main treatments to track your progress over time. The total duration of participation and the frequency of visits would be explained in detail by the study team, but it's common for such studies to run for several years, with more frequent visits initially and then less often.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by exploring a new, targeted way to treat your prostate cancer that might lead to better control of the disease in the long term. However, as with any medical treatment, there are potential risks and side effects associated with both hormone therapy and SBRT, which the study team will explain in detail. It's important to remember that joining a clinical trial means you might not receive the new treatment, as some participants get the standard treatment to allow for comparison. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Odette Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is 'hormone-sensitive oligometastatic prostate cancer'?

It means your prostate cancer has spread to a few small areas, and it still responds to treatments that lower male hormones, like testosterone.

What is a PSMA PET scan?

It's a very advanced type of scan that can find prostate cancer cells that might be too small to see on regular scans.

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a highly precise type of radiation treatment that delivers strong doses of radiation directly to the cancer spots, limiting harm to surrounding healthy tissues.

Will I definitely get the new SBRT treatment?

This study is comparing SBRT plus hormone therapy to hormone therapy alone. You'll be assigned to one of these groups, so you might or might not receive the SBRT.

What if my cancer starts to grow again?

The study team will closely monitor your cancer, and if it progresses, they will discuss further treatment options with you, outside of the study’s specific protocol if necessary.