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A New Non-Invasive Approach to Painless Prostate Cancer Screening

A New Non-Invasive Approach to Painless Prostate Cancer Screening

Prostate cancer, caused by the abnormal and uncontrolled growth of the prostate gland, is a global concern. According to the U.S. Centers for Disease Control and Prevention, one in six men have a chance of developing prostate cancer. Nearly 2,000 men in Hong Kong develop this cancer each year. Prostate cancer is a slow-growing cancer and usually has no obvious symptoms in the early stages of the disease. If treated early, the side effects of treatment can be reduced.

However, the most effective diagnostic method is invasive, which brings a considerable degree of pain, and may lead to false-positive or false-negative results. Professor Wong Ka-Leung, Professor and Head of the Department of Chemistry at Hong Kong Baptist University, has developed a new non-invasive method with an accuracy of over 90%, thereby accurately and conveniently assessing the risk of cancer from the urine of patients.

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Blind spots of existing inspection methods

The most effective way to diagnose prostate cancer is via a biopsy i.e. when a doctor uses a biopsy gun to remove tissue from the prostate by inserting a needle into the prostate from the perineum. Do you know how long the process can take?

1-3 minutes 5-15 minutes 20-30 minutes

Correct answer: 20-30 minutes。
During the process, more than ten extraction steps are performed and the patient will suffer considerable pain, with potential blood in the urine and even a bacterial infection.

To find out whether the patient needs to undertake the biopsy procedure, the doctor will usually perform a preliminary diagnosis called a “rectal exam” or a “serum prostate-specific antigen (PSA) test” beforehand. A PSA test is a blood test that is more common than a rectal exam. For Asians, a PSA level above four is considered high-risk and a “biopsy” is recommended for diagnosis. However, a “PSA level above 4” is not necessarily a result of prostate cancer; it can also result from prostate enlargement, infection or medication. Therefore, a PSA test may give false-positive or false-negative results.

According to the Center for Health Protection, only one out of four patients who undergo a PSA test followed by a biopsy actually has prostate cancer! In other words, many men who undergo the test have to suffer pain and distress for no apparent reason.

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The new effective, painless way

In order to reduce unnecessary biopsies and find a more reliable and non-invasive way to diagnose prostate cancer, Professor Wong Ka-Leung of the Department of Chemistry, HKBU, together with the Department of Surgery, Division of Urology, The Chinese University of Hong Kong (CU Medicine), have worked together since 2014 to develop a new biomarker to complement the PSA test that spots the lower level of spermidine (a biological alkaloid molecule) in prostate cancer patients. The results show that spermidine levels (a biologic molecule) are lower in prostate cancer patients providing a clue to a more accurate diagnosis.

The team recruited 905 patients at Prince of Wales Hospital and North District Hospital to participate in the study between 2015 and 2019. Patients with PSA levels above 4 underwent a biopsy procedure and 30ml-samples of urine were collected to assess spermidine levels and the net method’s accuracy.

Among the 600 patients with PSA levels between 4 and 20, 185 (30.8%) were diagnosed with prostate cancer after biopsy. Among the 600 patients with urine samples, 49% of those with spermine levels in the lowest quartile had prostate cancer, nearly three times as many as those with spermine levels in the highest quartile, indicating that those with lower levels may be at higher risk for cancer.

The team then used risk factors such as rectal exam results, PSA levels and prostate volume to develop a “spermine risk score”. Patients with a score above 6.2 were considered high risk and recommended for biopsy. Based on the data, about 37% of patients who were originally defined as having a biopsy were cancer-free and should be exempted from the biopsy. The study confirmed that urine spermidine and the “spermidine risk score” was effective in identifying men at high risk for prostate cancer and helped reduce unnecessary biopsies.

Development of chemical reagents to facilitate testing

The team not only has found a more accurate method but also developed a more convenient test tool which makes the screening of PCa more common and convenient.

The team invented the “Prostate Cancer Non-invasive Urine Test Kit”. It detects biomarkers of cancer cells in urine at one-tenth the cost of a PSA blood test.

The research team also found that the concentration of urinary polyamines in human urine is closely related to the risk of prostate cancer. Therefore, they developed a chemosensor that can detect urinary polyamines in the fluid. Then, the team used it to develop a highly sensitive compound that can accurately detect the concentration of urinary polyamines in a urine sample. The user simply mixes a urine sample with a chemical test at home. Within a short time, he will know the probability of developing prostate cancer and decide whether to seek further medical attention.

The advantage of this test method is that the colour can be used to determine the results with the naked eye quickly. The process is non-invasive and demonstrates a high level of accuracy while also being cost-effective. Users only need to use urine for cancer detection through this invention, which significantly enhances convenience and makes cancer screening more popular.

The team also collaborated with Prince of Wales Hospital to collect weekly urine samples for early clinical diagnosis of prostate cancer using a patented technology of more than 80% accuracy, which is two to three times more accurate than the most commonly used PSA test. Currently, the team is working on further research to further increase the accuracy of the test to 90% or higher.

Meanwhile, the team is exploring and studying different biomarkers hoping to apply this technology to the detection of other cancers.

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Recognition

“Spermine Risk Score” has been launched in Hong Kong this May, which is called “PURE Index”. It aims to evaluate the risk of prostate cancer of men with elevated PSA level, the public can visit the urologists for more details.

The team not only plans to cooperate with medical institutions in China and apply for NMPA Accreditation, hoping the testing service can be used in the domestic medical system, they will also register in PMDA in Japan.


“Prostate Cancer Non-invasive Urine Test Kit” has been recognised by many international organisations since its launch. At the same time, the team is trying to make it more popular so as to benefit more people.

Commercialisation

The “Prostate Cancer Non-invasive Urine Test Kit” will be commercialised and launched in Hong Kong in 2022 so that every household can have the opportunity to be tested at any time.

International accreditation

Special Gold Award of Jury Commendation at the 47th International Exhibition of Inventions in Geneva and International Special Award for Best Invention from the National Research Council of Thailand.

Research results published in the scientific journal “Prostate Cancer and Prostate Diseases.”

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“It has always been my dream to support my research with the profits of my own company. If this is successful, I hope this model can inspire other researchers.”

Professor Wong Ka-Leung is a dedicated researcher and has been publishing research papers since he was a university student. His hobbies are watching soccer and reading newspapers. With numerous awards and frequent exchanges with overseas scholars, he has found that scientific research in Hong Kong is often constrained by external factors, especially funding, and that sustained and long-term funding is crucial for innovative research. Therefore, he has set up a company to carry out basic research, which also provides internship opportunities for researchers from HKBU, offering a solid foundation for their future career development. He encourages future research talents:

“Not only to focus on theories in textbooks but also to get more exposure to different things and to believe that even if we have little power today, we can change the world in the future.”