As CEO of Prostate Cancer Research, Oliver Kemp has spent the last five years supporting new therapies for advanced prostate cancer. For a long time, little was offered to patients whose tumors have metastasized and spread from the prostate to the bones and other organs, but 2022 has already seen a number of signs of this
about to change.
A recent phase III clinical trial conducted by an international consortium of scientists from nine countries demonstrated some of the progress made. It turned out that a powerful new hormone therapy called darolutamide, manufactured by pharmaceutical company Bayer, can significantly increase survival and reduce pain in men with advanced prostate cancer when used in combination with standard therapies.
These results are just the latest breakthroughs in recent months for patients in the final stages of the disease. In December, a large clinical trial called Stampede found that combining two existing prostate cancer drugs — abiraterone and ADT — could increase six-year survival from 69 percent to 82 percent. Kemp is also optimistic about a new drug called olaparib, the first drug specifically targeting a subset of patients with advanced prostate cancer.
Targeting those who have a mutation in the BRCA1 and BRCA2 genes, olaparib works by interfering with an enzyme that helps cancer cells repair themselves and inhibits tumors’ ability to grow and spread. Clinical studies have shown that it can double the average survival time of patients with BRCA mutations.
“In the UK we’re talking about probably 500 patients a year whose lives could be saved by olaparib,” says Kemp. “So it’s really significant.”
Interest is also growing in another new class of treatments called targeted radionuclide therapies. These drugs attach to tumors before releasing very small amounts of radiation that dissipate within hours, meaning there are far fewer side effects than traditional radiation therapy.
“That’s where, when we look at the results, we’re like, ‘Wow,'” says Kemp. “You could sit here a few weeks before dying, and that will prolong your life immensely. The pharmaceutical company Novartis is currently conducting a phase III clinical trial, which we are waiting for.”
There have also been advances for patients recently diagnosed with prostate cancer. A minimally invasive technique called the NanoKnife, which uses bursts of rapid electrical impulses guided by MRI scans to kill tumors, has been approved for use in the NHS. Experts hope that this will avoid many problems associated with conventional surgery.
“In many cases, patients who have been recommended surgery are later left with erectile dysfunction and incontinence,” says Kemp. “NanoKnife can have a significant impact on these outcomes as it is gentle on nerve endings and therefore makes a big difference in quality of life. It’s also less invasive so patients are less afraid of it and it takes pressure off the NHS as it can be done on an outpatient basis.”
With new treatments, however, the question arises as to how they can be financed. While NanoKnife received the green light from the National Institute for Health and Care Excellence (NICE) – which makes recommendations on which medicines should be funded by NHS England – the health authority balked at the annual cost of olaparib of £37,000 per patient.
Aamir Ahmed, who heads the Prostate Cancer Research Center at Kings College London, believes that more research needs to be directed towards medicines that have already been clinically proven to be safe for human use in other diseases and which are being reused for prostate cancer could.
“Improvements in cancer therapy have slowed over time while costs have increased exponentially,” he says. “The average cost of cancer drugs increased from $100 per month in 1965 to $10,000 per month in 2018. Recycled drugs can bridge large chunks of drug development and clinical trial phases, which could ease the financial burden
Another approach is to invest more in therapies, such as cancer vaccines, which offer the potential to halt the disease in its tracks and prevent it from spreading or metastasizing to other organs.
Swedish biotech RhoVac has spent the last few years developing a vaccine that stimulates T cells to attack and destroy cancer cells that have high levels of a protein called RhoC. This protein gives cancer cells the ability to migrate and invade other tissues, causing them to metastasize.
“There have been some attempts to develop vaccines against prostate cancer in the past, but they targeted very late-stage tumours,” says Anders Månsson, CEO of RhoVac. “It’s much better to vaccinate when the immune system has a reasonable chance of overcoming the obstacle when there are as few metastatic cancer cells as possible.”
So far the results have been very promising. RhoVac started a phase I/II clinical trial of the vaccine in 2018, and more than three years later, Månsson says almost all of the patients involved are still immune to the disease. A Phase IIb study is currently ongoing, with results expected to be published later in 2022.
If the latest study proves successful, Månsson believes it could represent a paradigm shift in how we treat patients in the early stages of the disease.
“Right now, localized prostate cancer is usually diagnosed and treated with surgery or radiation,” he says. “But there is no treatment that prevents metastasis.”
But for cancer vaccines to be most successful, better diagnostic and screening programs that can detect the disease earlier in its course are needed. According to the charity Prostate Cancer UK, 9,500 men in the UK are diagnosed with prostate cancer at an incurable stage each year.
Currently, the gold standard diagnostic tool is the PSA (prostate-specific antigen) test, which measures the level of circulating PSA, a protein secreted by both cancerous and non-cancerous tissues in the prostate. But while high PSA levels can indicate cancer, it’s not always the case, leading to false positives.
“Right now it’s the best we’ve got,” says Kemp. “It’s cheap and should be part of the process leading to further investigation. But the problem is the false positives, and many people are treated quite aggressively.
“Or you could have a very slow growing cancer and decide to have surgery just because you had a positive PSA test and you might not need that surgery right away. You can suffer from erectile dysfunction and incontinence for five to ten years of your life. So we hear from a lot of people who regret the treatment.”
However, the combination of increasing advances in imaging technology and artificial intelligence (AI) may point the way forward. Last month, scientists at the University of California, San Francisco presented data at a conference describing how AI models can use pathological imaging data to predict the long-term prognosis for prostate cancer patients, with greater accuracy than the PSA test.
In North Wales, in December, the Betsi Cadwaladr University Health Board became the first clinical center in the UK to use an AI pathologist to help men diagnose prostate cancer. The tool takes scans of biopsies from patients suspected of having prostate cancer and feeds them through an app called Galen, which can process slides from multiple patients in minutes. If anomalies are detected, an advisor is automatically alerted.
Kemp believes this is the way to go. “AI technology is much cheaper,” he says. “And it’s actually more accurate.
The human eye has flaws and if someone is tired at the end of the day you will have a worse result than if someone is looking at your scan at the beginning of the day. So we’re excited about this because we can encourage a different way of diagnosing rather than just relying on the traditional PSA test, which has its flaws.”
“I am living proof that research can have a real and lasting impact”
In September 2016, Brian Milne had just arrived in Florida for a family vacation when he began experiencing persistent back pain and difficulty urinating. He attended an outpatient clinic expecting to be treated for a urinary tract infection, but instead doctors ran a battery of tests and diagnosed him with metastatic prostate cancer.
He was told he had three to five years to live, a devastating blow for a 64-year-old who had always believed himself to be healthy.
“I was told the cancer had spread to the bones,” says Milne. “That meant I could be treated but never cured. A lot to digest for someone who hasn’t seen their GP in 40 years.”
But upon his return to the UK, Lee was given the opportunity to take part in Stampede, a groundbreaking clinical trial that has transformed the lives of many advanced prostate cancer patients over the past six years by showing how combination therapies can keep the disease in check and that prolong life.
In December 2021, a breakthrough finding showed that using two commonly prescribed hormone treatments at the same time can increase six-year survival from 69 percent to 82 percent.
Milne has been taking a combination of chemotherapy and hormone treatments as part of Stampede for more than five and a half years now.
“I thought of prostate chemotherapy as part of palliative care, but we all liked the sound of the average patient living longer and having a better quality of life,” he says. “Fast forward to February 2022 and the latest scans show I have no active bone metastases.”
He credits the treatment with a significant prolongation of his life. “I am proof that research can have a real and lasting impact on the lives of individuals and their families,” he says. “Being involved in the lives of my grandchildren has been particularly rewarding. I continue to take full advantage of the extra time that has been gifted to my family and I.”