She went to her family doctor, followed by x-rays, and a bronchoscopy to look inside her airways. By January 2022, Karen was formally diagnosed with grade 2 neuroendocrine cancer.

While neuroendocrine tumours can occur anywhere in the body, in Karen’s case, hers were in her lymph nodes and gastrointestinal tract.

“I hadn’t had any symptoms, I didn’t even know,” says Karen, who was 48 years old at the time; a sports mom with two teenagers in the house. “I was shocked, I didn’t experience anything, and still haven’t (besides that chest cold discomfort feeling). It never crossed my mind that I may have cancer.”

A clinical trial testing radioligand therapy (RLT)

Upon speaking to her radiation oncologist, Dr. Sten Myrehaug, Karen signed up for a clinical trial to receive radioligand therapy (RLT) as the first course of treatment.

Although neuroendocrine cancer is uncommon, its incidence is rising rapidly and few treatments exist for these patients as this kind of cancer is resistant to most therapies; making it challenging to treat.

RLT involves injecting radioactive isotopes through an IV – in this case, with the drug Lutathera – in order to target specific cancer cell receptors, and deliver more targeted and precise radiation to kill cancer cells while preserving healthy tissue.

While RLT has been used in the treatment of some other cancers in later stages of a patient’s care path, this study evaluated for the first time the use of RLT earlier as a first-line (or “up front”) treatment for patients newly diagnosed with grade 2 or 3 advanced gastrointestinal neuroendocrine tumours.

Karen started off on the “standard arm” of the trial with two intramuscular injections – one in each hip – of high-dose long-acting release (LAR) octreotide.  This is used to in order to stop or slow down the progression of tumours.

When one of her tumours started to grow in size, she was then switched to the treatment arm of the trial that offered infusions of the radioactive medication Lutathera.

Treatment took up to 30 minutes, with an IV in each arm, with the rest of the day with anti-nausea medications.

“Besides the nausea, I didn’t have any other side effects, except having to be isolated from my family for a week. I locked myself in my bedroom with my own bathroom. I had my own dishes, everything had to be washed separately, I equipped myself with my laptop and some trash magazines for the week.”

The nausea got better after each treatment and she continued working full time in healthcare administration right through without any symptoms. She finally took six months off last year to “concentrate on me” and has been back to work since October.

Asked if anything has changed for her, Karen says: “I try to walk more than I did in the past, to keep up with healthy living, getting better. Other than that, nothing has changed.”

The results: a game changer in the practice of cancer treatment

Since the multi-site trial closed, the researchers assessed the data and the results were recently published in the journal The Lancet: the RLT that Karen and other participants received showed a reduction of the risk of advanced neuroendocrine tumour progression by 72 per cent.

Karen’s response upon hearing these results? “I couldn’t be happier.”

“The results confirm the clinical benefit of earlier use of RLT for newly-diagnosed patients with these types of aggressive and life-threatening tumours,” says Dr. Simron Singh, global principal investigator of the trial, and medical oncologist and cofounder of the Susan Leslie Clinic for Neuroendocrine Tumours at Sunnybrook’s Odette Cancer Centre.

“Cancer care has traditionally been treated by surgery, drugs or radiation; RLT is a game changer in the practice of cancer treatment. While it’s technically radiation, it is given via a chemotherapy route through the blood until it reaches the precise location of the tumour. This is the next step in personalized targeted cancer therapy for patients, focused on more effectively killing cancer cells, while limiting the damage to surrounding healthy tissues.”

This past March, once she knew it was safe to do so, Karen decided to get a tattoo of boxing gloves with a zebra pattern. The zebra is the awareness symbol for uncommon or rare diseases including neuroendocrine cancers.

“This was about me fighting my cancer. It symbolized for me my strength and just knowing I’m going to beat this and fight through this. It gives me strength.”

Photo credit: Kevin Van Paassen/Sunnybrook

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A clinical trial is a research study that involves people. After showing promise in a lab, a clinical trial is the next step. Clinical trials look at the effect of a medical action on people’s health and often compare one treatment to another. The studies often look at how well new treatments work and how safe they are to administer.

When it comes to prostate cancer — the most commonly diagnosed cancer in men — there are tons of trials with a wide range of focuses.

“There’s a trial available for every point of the prostate cancer experience – from detection to diagnosis to treatment and beyond. There’s a whole team here dedicated to this,” said Dr. Stanley Liu, a radiation oncologist at Sunnybrook. “These trials are looking for better ways to find prostate cancer, better ways to figure out whose cancer will be aggressive, and better ways to treat it at any stage.”

How can we see the cancer?

Many researchers are looking at how prostate cancer is detected and diagnosed. This type of trial might look at the use of imaging and what type of imaging can best see the cancer. Participants could be randomized to get one type of image or another.

Whose cancer will be aggressive?

Some men with low-grade prostate cancer may never go on to have an advanced form of the disease. But how can doctors determine who’s cancer will be aggressive?

“At Sunnybrook, we are involved in several trials that are looking at ways to determine who’s prostate cancer will be more aggressive – for example, looking at cells in urine to see if there’s signatures in there that indicate the cancer is more aggressive,” Dr. Liu said. This type of trial might involve blood tests, urine test or other samples being collected and examined.

How can we best treat prostate cancer? 

How you are diagnosed with prostate cancer and treated is based on many years of research, evidence and trials. Researchers constantly revisit that evidence to come and with better, safer ways to find and treat the disease.

A Sunnybrook-trial led to the widespread use of “active surveillance” for prostate cancer, where men with early stage disease are closely monitored rather than treated aggressively. The 15-year results were recently published by Drs. Andrew Loblaw and Laurence Klotz from Sunnybrook, and they demonstrated that this is a safe and effective approach to manage early stage prostate cancer. This key trial helped make active surveillance a standard-of-care in North America.

At Sunnybrook and around the world, researchers such as Dr. Loblaw have been looking at newer forms of radiation that target the tumours more precisely. One example of this is stereotactic body radiation therapy (SBRT),  where high levels of targeted radiation are given over a short period of time. This type of treatment is already used for other cancers. At Sunnybrook, we are involved in several SBRT trials, looking at if a shorter course of higher dose radiation (e.g., 5 days versus 20 days) can improve prostate cancer cure while minimizing effects on a patient’s quality of life. This would involve radiation treatments as well as surveys or interviews to help determine how your quality of life is after treatments.

How can we treat prostate cancer that comes back or is advanced?

These types of trials might add an additional chemotherapy drug or a targeted agent to the current standard of care (radiation, surgery or chemotherapy) to see if there are better patient outcomes.

How do I know if a trial is right for me?

At an academic health sciences centre, there are many options for trials. There is infrastructure in place to allow involvement with lots of trials. Some of Sunnybrook’s doctors are the lead investigators or the site leads on an international trial. Talk to your doctor for more information about what trials you might be eligible for.

Do I have to join a trial?

Being a part of trial is a personal decision. It can be overwhelming to learn about them all, but ultimately it’s up to you as the patient.

“Your care team can offer you information about whether you are eligible for a trial so that you can make an informed decision on whether you want to join a trial,” Dr. Liu said.

If you are not in a trial, you will receive the standard treatment. By participating in a clinical trial, you may be among the first to receive a new treatment that is otherwise not available. But, the new treatment has not yet been proven to be better than the current standard. It’s important you discuss this with your care team.

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While most research begins in the lab, there are many more steps before the research gets to people.

A clinical trial is a research study that involves people. After showing promise in a lab, a clinical trial is the next step. Clinical trials look at the effect of a medical action on people’s health and often compare one treatment to another. The studies often look at how well new treatments work and how safe they are to administer.

Sasha Manohar, clinical research associate, and Maurice Zakhem, data manager, both in the Odette Cancer Centre Clinical Research Program, gave us a little crash-course in clinical trials. If you have questions about clinical trials, talk to your doctor.

How is a clinical trial different from other research?

Clinical trials, unlike other research, always involve humans. The studies are thoroughly reviewed by trained staff who decide whether or not the research is safe and ethical to perform on humans. These studies are performed with patient safety and confidentiality as a priority and you are always given a choice whether or not to participate.

Who is involved in a clinical trial?

A whole team is involved in running a clinical trial at a hospital. All clinical trials are supervised by a doctor at your hospital who either treats you or is part of a team that is involved in your care. This doctor is considered a principal investigator (PI) and their colleagues are called co-investigators. Clinical Research Associates (CRAs) or Clinical Research Nurses also help guide you through your participation in the study. Depending on the type of clinical trial, you may also have contact with hospital staff from medical imaging, phlebotomy (the blood lab), and other departments.

Who can be in trials?

Each clinical trial has requirements about who can participate. These are called eligibility criteria. Think of it like that phrase “That’s comparing apples to oranges!”. Clinical trials need to compare apples with apples (Sorry to compare people to fruit!) The researchers need make sure all participants on the trial are similar in key ways so they can be confident the results of the trial come from the treatment being studied and not from other factors. So, if the trial is looking at a new chemotherapy drug on breast cancer, the researchers may want to be sure the participants have the same type and stage of cancer, have all had the same amount of radiation and are in a particular age range.

These eligibility criteria commonly include the type or stage of cancer, previous treatment for the cancer and the patient’s overall health.

How do you get into a trial?

To become a part of a clinical trial, speak with your doctor. Your doctor is the first link to participating in a clinical trial. Your doctor can see if you meet any of the eligibility criteria for clinical trials at the Odette Cancer Centre, or at other cancer centres nearby. If your doctor thinks you might be suitable, he or she will give you an informed consent form that tells you more about the study. You’ll also meet with one of our clinical research associates to discuss the trial further, ask any questions you have and decide whether to participate or not.

How long do trials take?

The length of time you participate in a clinical trial can have a huge range, from a few months to a few years to even longer. It all depends on what questions the trial is trying to answer. It’s common for clinical trials to follow patients for a long time after they have finished treatment to look for long-term outcomes such as side effects, the cancer worsening or returning. Ask your doctor how long you have to participate if you are thinking of taking part in a clinical trial. You can also ask the research staff when you may know the results of the trial.

Do they always work as a better treatment?

By participating in a clinical trial, you may be among the first to receive a new treatment that is otherwise not available. But remember – there are both risks and benefits to taking part in a clinical trial. While you may be among the first to benefit from a new treatment, there is also the risk that the new treatment isn’t better than the current standard of care. As with all cancer treatments, a new treatment may not benefit all participants. It is important to discuss possible risks and benefits with your doctor as well as those close to you.

More resources:

Cancer Clinical Trials at Sunnybrook
Canadian Cancer Society
National Cancer Institute
It Starts With Me – Network of Networks
Clinicaltrials.gov

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