FDA approves new indication for Illuccix in metastatic prostate cancer

The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom 177Lu-PSMA-617 is indicated.

Story: https://www.urologytimes.com/view/fda-approves-new-indication-for-illuccix-in-metastatic-prostate-cancer

The FDA has approved a supplemental New Drug Application (sNDA) for Illuccix, a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (PSMA-11) injection. The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617; Pluvicto) PSMA-directed therapy is indicated.1

“As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There’s no doubt that appropriate selection of patients for PSMA targeted radioligand therapy is dependent on appropriate imaging. Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management,” Oliver Sartor, MD, Medical Director at Tulane Cancer Center, stated in a press release.1

The FDA previously approved Illuccix for use following radiolabeling with gallium-68 as a radioactive diagnostic agent for PSMA-PET imaging in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy; or with suspected recurrence based on elevated serum PSA level.2

VISION trial

Illuccix’s new indication means the PSMA-PET imaging product can now be used to determine if a patient is eligible to receive 177Lu-PSMA-617, which, before prescribing requires that the patient receive imaging with an approved gallium-based PSMA-PET agent showing that their tumor has the required level of PSMA expression.

The pivotal VISION trial, which supported the approval of 177Lu-PSMA-617, used Illuccix to help identify patients who met the study criteria for treatment with the PSMA targeted radioligand therapy.

Results from the VISION trial showed that adding 177Lu-PSMA-617 to standard of care (SOC) led to a nearly 40% reduction in the risk of death versus SOC alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.3At a median follow-up of 20.9 months, the addition of LuPSMA improved the median overall survival by 4 months over SOC alone (HR, 0.62). Adding the targeted radioligand therapy also led to a 5.3-month improvement in median radiographic progression-free survival, translating to a 60% reduction in the risk of progression or death (HR, 0.40).

“We welcome the FDA’s decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease,” Kevin Richardson, CEO for Telix Americas, part of Telix Pharmaceuticals, the manufacturer of Illuccix, stated in the press release.1

Dr. Robert Tarzwell, MD, FRCPC

The US Food and Drug Administration formally approved the use of gallium-PSMA-11 PET/CT scans for determining eligibility for lutetium-177-PSMA therapy in metastatic castration resistant prostate cancer (mCRPC). INITIO currently offers both the gallium scan in prostate cancer and lutetium based mCRPC therapy. Discuss with your oncologist if this may be appropriate therapy for you.

Vancouver Clinic Earns Therapeutic License to Administer New Drug to Treat Prostate Cancer

“We are thrilled to offer this novel treatment in Canada to help prolong lives”

source: https://www.newswire.ca/news-releases/vancouver-clinic-earns-therapeutic-license-to-administer-new-drug-to-treat-prostate-cancer-870580852.html

VANCOUVER, BC, March 7, 2023 /CNW/ – INITIO Medical Group is the first private nuclear medicine facility in Canada to be awarded a therapeutic license to administer Lutetium-177-PSMA (prostate specific membrane antigen) for the treatment of advanced prostate cancer, specifically “metastatic castration resistant prostate cancer” also known as “mCRPC”.

Lu-177-PSMA, an example of a new kind of cancer treatment called “RLT” (radioligand therapy), is a game-changer for those suffering from the advanced form of the most common cancer in Canadian men, and their third-leading cause of death from cancer.

What makes Lu-177-PSMA and the coming wave of RLT compounds such cutting-edge treatments is that they target and destroy cancer cells precisely, while minimizing exposure to healthy tissue, often with fewer side effects than chemotherapy, traditional radiation and other treatments.

“This therapeutic license allows us to offer this ground-breaking treatment to patients who may not have had access to it otherwise,” says Dr. Kalevi Kairemo, President-Elect World Association of Radiopharmaceutical and Molecular Therapy (WARMTH)  and Senior Scientific Advisor for INITIO Medical Group.

INITIO received the license from the Canadian Nuclear Safety Commission last week and will begin offering patient treatments after March 15. INITIO will be the first private clinic in Canada to offer Lu-177-PSMA treatment, following the approval of the compound by Health Canada in September, 2022.

The compound is administered intravenously over about a minute, and it binds to cancer cells and destroys them with ultra short range “beta particles”. These particles travel a maximum of 2 mm once emitted by the lutetium nucleus, ensuring they selectively target cancer cells and spare healthy tissue. Any compound which does not bind to cancer tissue is primarily cleared from the body by the kidneys.

“Lutetium-177 has demonstrated the ability to meaningfully prolong life in the international VISION trial, involving patients with advanced cancer, many of whom otherwise would have very few therapeutic options. We’re excited to offer this treatment in Canada,” says Dr. Rob Tarzwell, Medical Director for INITIO Medical Group, and a Clinical Assistant Professor on the Faculty of Medicine at the University of British Columbia.

“The approval of this license was made possible by the tireless efforts of our team, who worked closely with regulatory agencies and other stakeholders to ensure that we meet all the necessary requirements and standards,” says Dr. Philip Cohen, INITIO Director and Division Head, Nuclear Medicine, Lions Gate Hospital in North Vancouver, adding there are plans to apply for licenses at other facilities across Canada.

At present, although Lu-177-PSMA is Health Canada approved and an effective prostate cancer treatment, it is not publicly funded.


INITIO is Western Canada’s only private PET/CT scan facility. With over 20 years experience, we offer Rapid  PET/CT and CT scans and nuclear medicine treatments with no wait list. INITIO has diagnostic scanning for cancer, cognitive impairment, and cardiac sarcoidosis, and now, offers prostate cancer therapy. With this latest addition, INITIO Medical Group reaffirms its commitment to providing the most advanced and effective treatments to its patients. We are proud to be able to offer Lu-177 PSMA therapy and look forward to the positive impact it will have on the lives of those affected by prostate cancer.


For further information: For more information and media interview requests: (604) 678-9274, info@initiomedical.ca, www.Initiomedical.ca

PET Scans: A High-Tech Look Inside Your Body

PET CT scans are often used to diagnose and monitor a variety of conditions, including cancer, heart disease, and brain disorders.

Before having a PET scan, your doctor may ask you to avoid certain foods or medications and possibly even fast for a few hours. This is to ensure the accuracy of the scan. You may also be asked to rest before the scan as physical activity can affect the results. It’s important to carefully follow your doctor’s instructions to get the most accurate scan possible.

PET scans are generally considered a safe and effective way to diagnose and monitor medical conditions, as the amount of radiation you are exposed to is low and the benefits of the scan typically outweigh any potential risks. However, it is important to speak with your doctor if you have any concerns before undergoing a PET scan, particularly if you are pregnant or breastfeeding, or if you have allergies or kidney problems. Your doctor can help you understand the potential risks and benefits of the scan and assist you in determining if it is the right choice for you.

PSMA PET Scan for Prostate Cancer

PSMA PET scans, a specialized type of imaging test, are becoming all the rage in Canada for detecting prostate cancer? While they may not be available everywhere just yet, they’re definitely worth considering if you’re interested in staying on top of your prostate health. To learn more about whether a PSMA PET scan might be a good fit for you, just chat with your doctor or a prostate cancer specialist. They’ll have all the scoop on availability and the potential benefits of these cutting-edge scans.

And that’s not all – there are all sorts of other exciting PET scans out there too! For example, dotatate PET scans use a special chemical called dotatate that’s injected into the body and absorbed by certain cells. The PET scan machine can then pick up on the dotatate and create beautiful images of the tissues and organs where it’s present. These scans are often used to search for cancer in the pancreas, thyroid, and other parts of the body.

And that’s just the tip of the iceberg – there are all sorts of specialized PET scans that can be used to look for specific types of problems or diseases. For instance, there are PET scans that can be used to search for Alzheimer’s disease and other forms of dementia, as well as scans that can be used to diagnose and monitor brain injuries and disorders. And if you’re feeling under the weather, there are even PET scans that can be used to look for infections, inflammation, and other types of diseases.

PET scans may seem intimidating, but they’re just one of the many tricks up a doctor’s sleeve when it comes to diagnosing and treating medical conditions. Think of them as just one piece of the puzzle. Doctors also use things like blood tests, x-rays, and biopsies to get a full picture of a patient’s health. And they don’t stop there – they take into account a patient’s medical history and other factors to determine the best course of action. So while PET scans may be part of the process, trust that your doctor has all the tools and information they need to get you back to feeling your best.

Are you curious about PET scans and how they can benefit your health?

Great news! PET scans are just one of the many tools that doctors and healthcare professionals use to diagnose and treat medical conditions. In fact, they’re often used in combination with other tests and procedures like blood tests, x-rays, and biopsies to get a complete picture of a patient’s health. So don’t hesitate, talk to your doctor about how PET scans can be a valuable part of your healthcare journey. And remember, knowledge is power when it comes to your health. Stay informed and be an active participant in your own healthcare to ensure the best possible care. Trust us, your doctor has all the tools and information they need to help you feel your best.

PET scans are a truly remarkable tool for doctors and healthcare professionals. Not only can they reveal the inner workings and structure of the body, but they can also provide valuable insights into diseases like cancer. By showing how the disease is affecting the body and how it’s likely to progress, PET scans can help doctors make informed decisions about the best course of action. And when it comes to monitoring the effectiveness of treatment, PET scans are a crucial asset.

But here’s the best part – PET scans are generally non-invasive and painless. No need for surgery or other procedures, just lay back and relax on a comfortable table while the scan is being performed. The only preparation required is usually to avoid certain foods and medications beforehand and to fast for a few hours. It’s a small price to pay for such an invaluable tool in the quest for optimal health.

PET scans are medical tests that can give doctors valuable information about your health, but it’s important to be aware of some of their limitations. One thing to consider is cost – if your insurance or healthcare plan doesn’t cover the cost of the PET scan, you might have to pay for it yourself or look for financial assistance. Another limitation is availability – not all hospitals or medical centers offer PET scans, so you might have to travel to have the test done.

It’s also important to be aware of the accuracy of PET scans.

While they can be very useful, they can sometimes produce false positive or false negative results. This means they may show a problem that isn’t actually there, or they may not show a problem that is present. To help make sure you get accurate results, it’s important to follow your healthcare team to instructions carefully and tell them about any allergies or medical conditions you have that might affect the accuracy of the scan.

Despite these limitations, PET scans can still be very helpful for both you and your doctor. If you have any questions or concerns about PET scans, or if you’re thinking about having one, it’s always a good idea to talk to your doctor. They can give you more information and help you make a decision about whether a PET scan is the right choice for you.

PET Scan vs. CT Scan: What’s the Difference?

PET Scans

PET scans are a form of medical imaging test that creates precise images of the body’s organs and tissues by using a small amount of radioactive material, known as a radiotracer. A specific camera is used to detect radioactivity and provide photographs of the body once the radiotracer is injected into the subject’s body.

Contrarily, CT scans use X-rays to provide precise images of the body’s tissues and organs. The patient lies on a huge equipment called a CT scanner that has a hole in the middle while the scan is being done. A detailed 3D representation of the body is produced as the equipment spins around the subject while simultaneously taking a number of X-ray photographs.

Advantage of PET Scans

One key advantage of PET scans is their ability to provide functional information about the body’s tissues and organs. While CT scans can show the structure of these tissues and organs, PET scans can show how well they are functioning. This is because the radiotracer used in PET scans accumulates in areas of the body with increased metabolic activity, such as cancer cells or certain areas of the brain associated with diseases or disorders. This allows PET scans to detect problems at an early stage, when they may not yet be visible on CT scans.

For instance, PET scans can be used to find cancer early. In contrast to healthy cells, cancer cells typically have a greater metabolic rate, and the radiotracer used in PET scans builds up in body regions with higher metabolic activity. This means that PET scans are a crucial tool in the diagnosis and treatment of cancer since they frequently detect cancer before it is detectable on CT scans or other imaging procedures. PET scans can also assist in detecting cancer recurrence and monitoring the efficacy of cancer treatment.

Other illnesses, such heart disease and brain abnormalities, are also detected and diagnosed by PET scans. For instance, PET scans can be used to identify abnormalities in the brain brought on by diseases like Parkinson’s and Alzheimer’s. They can also be used to find heart issues, like damage to the heart muscle following a heart attack. PET scans can be used to diagnose heart illness by measuring blood flow to the heart and locating regions of the organ that aren’t receiving enough oxygen. This can aid medical professionals in choosing the patient’s best course of therapy.

PET scans provide certain additional benefits over CT scans in addition to their diagnostic capabilities. For instance, compared to CT scans, PET scans do not subject the patient to as much radiation. Despite the fact that both PET and CT scans expose patients to some radiation, PET scans normally use less radiation than CT scans do. For patients, such as youngsters and pregnant women, who may be at risk of radiation-related side effects, PET scans are a safer option.

Furthermore, PET scans are frequently faster and more comfortable for the patient than CT scans. While CT scans necessitate the patient to remain still for a longer period of time, PET scans typically take a few minutes to complete. Additionally, PET scans do not require the patient to hold their breath, unlike CT scans, which some people find uncomfortable.

PET Scans do have some restrictions.

Due to the need for some specialized tools and qualified workers, PET scans are not as commonly accessible as CT scans. This means that patients may need to go to another place in order to receive a PET scan because not all hospitals and medical facilities have PET scanners. Due to the use of a radiotracer, which must be created and delivered by qualified persons, PET scans can also be expensive. Some people who might not have insurance coverage for the treatment or who might have high deductibles or copays may find this to be a hurdle.

Another drawback of PET scans is that they are less capable than CT scans of generating accurate images of specific bodily structures, such as bones and blood vessels. X-rays, which can penetrate bone and produce precise images of the bone’s structure, are used in CT scans. Contrarily, because bone cannot be penetrated by PET scans, they might not be as useful for identifying abnormalities with the bones as CT scans are.

A possible disadvantage of PET scans is that they aren’t as competent as CT scans in producing reliable images of specific body structures such as bones and blood arteries. CT scans utilize X-rays, which can penetrate bone as well as provide exact images of the bone’s structure. PET scans may not be as effective as CT scans at detecting problems in the bones because they cannot penetrate bone.

Despite these drawbacks, PET scans are superior to CT scans in many ways, including their capacity to reveal functional information about the body’s tissues and organs, their capacity to detect cancer early on, and their usefulness in identifying and diagnosing other conditions like heart disease and brain disorders. The fact that they are quicker, more comfortable, and radioactively safer is also advantageous to patients.

PET Scan vs. CT Scan

In conclusion, both PET scans and CT scans are useful methods for diagnosing medical conditions. PET scans are particularly helpful for identifying and diagnosing cancer as well as other conditions like heart disease and brain disorders because they have the unique advantage of being able to provide functional information about the body’s tissues and organs. PET scans are an important tool in the field of medical imaging, despite having some drawbacks and perhaps not being as widely or inexpensively available as CT scans.

PET Scan vs. MRI: What’s the Difference?

PET Scans

The nuclear medicine imaging test known as a PET scan creates finely detailed three-dimensional images of the body’s functional processes, such as metabolism and blood flow. Cancer, heart disease, and neurological disorders are just a few of the conditions that are frequently diagnosed and monitored using PET scans.

Benefit of PET Scans

The ability to provide functional data about the body’s tissues and organs is one benefit of PET scans. PET scans produce images based on how the body’s cells are functioning rather than the density of tissues like conventional X-ray or CT scans do. This can be especially helpful in the detection and treatment of cancer since PET scans enable medical professionals to determine whether a tumour is malignant and whether it is actively growing or spreading.

High sensitivity is another benefit of PET scans. The ability of PET scans to identify extremely minute abnormalities in the body’s tissues and organs makes them valuable for the early diagnosis of cancer and other diseases. Furthermore, false-positive results from PET scans are extremely uncommon and have a high accuracy rate.

In comparison to other imaging modalities, PET scans also have a relatively quick examination time, with most scans taking less than an hour. For patients who might have trouble staying still for extended periods of time or who might become anxious during medical procedures, this can be especially crucial.

PET Scans do have some restrictions

One drawback of PET scans is their cost, which is typically higher than that of CT or MRI scans or other imaging modalities. A small amount of radioactive tracer must also be injected into the patient’s bloodstream prior to a PET scan, which may raise concerns for some people.


Using strong magnets and radio waves, the medical imaging technique known as MRI (Magnetic Resonance Imaging) creates precise images of the body’s tissues and organs. Cancer, heart disease, and neurological disorders are just a few of the many medical conditions that MRI is frequently used to diagnose and assess.

Advantages of MRI

Detailed images of the body’s soft tissues, such as muscles, tendons, and ligaments, which may not be as visible on other imaging modalities like CT or X-ray, can be produced by MRI, which is one of its advantages. MRI is helpful for the diagnosis and treatment of neurological conditions because it can produce precise images of the brain and spine.

The ability of MRI to image the body in multiple planes (slices) gives medical professionals the opportunity to view the body from various perspectives and get a more comprehensive understanding of the patient’s condition. Due to the lack of ionising radiation, MRI is typically more comfortable for patients than other diagnostic imaging modalities.

MRI does have some restrictions

The price of MRI exams, which are typically more expensive than other imaging modalities like CT or PET, is one drawback. Additionally, MRI uses a sizable, enclosed machine that some patients, particularly those who have claustrophobia, may find intimidating. MRI exams typically last 30 to 60 minutes, which is longer than other imaging modalities.

It is crucial to remember that both MRI and PET are useful diagnostic and therapeutic tools for treating medical conditions, and a healthcare provider should choose which modality to employ based on the unique requirements of the patient.

PET Scan vs. MRI: What’s the Difference?

In conclusion, both PET scans and MRI are beneficial medical imaging techniques, but they each have particular benefits and drawbacks. While MRI is particularly useful for creating detailed images of the body’s soft tissues and has the ability to image the body in multiple planes, PET scans are particularly useful for providing functional information about the body’s tissues and organs and are highly sensitive and accurate. The decision regarding which modality to employ in a given circumstance is based on a number of variables, including the patient’s unique medical condition and the objectives of the imaging examination. The most thorough and precise diagnosis and treatment plan may every once in a while, be produced by combining PET and MRI.