We discussed in a recent blog how focal therapy is emerging from the pandemic in terms of what's driving awareness and demand among prospective patients. What we didn't comment on is how the provision of focal therapy is advancing as new approaches and technologies are investigated, developed and adopted along the diagnostic and treatment pathway.
Focal therapy is all about accuracy – accuracy in hitting the target to treat prostate cancer and accuracy in avoiding healthy tissue and incurring unwanted side effects. Four things enable focal therapy to do this:
- A diagnosis of localised prostate cancer - making early screening & detection paramount
- the availability of precise imaging of the prostate followed by accurate contouring and reporting
- safe & accurate biopsy methods- sampling and histology
- a powerful & controlled energy source applied to ablate and destroy targeted cancerous tissue
Each of these areas is advancing through innovation and new technology, which, over time, we believe will make focal therapy more available, effective and accessible. Below we offer some highlights and indicate the directions of travel for you to monitor going forward.
Screening
GP-based PSA testing continues to be variable despite active campaigns to build public awareness about this. We continue to hear patients tell us about their requests for PSA testing being challenged and even denied. We will continue to support these campaigns and, in the meantime, can point to two advancements in screening for prostate cancer. At-home PSA testing with a finger-prick test is available privately here.
A recent Which? review commented:
“This test says it can detect abnormal levels of prostate-specific antigen (PSA) in the blood, but this is an unreliable marker of prostate health, and the test doesn't address the complications with this type of testing, nor the consequences of taking a PSA test. Our experts were concerned that the cut-off level for ‘normal' PSA used in this test is higher than NHS guidelines for men between 50 and 69, so there's a danger that men who would be urgently referred on the NHS would be told by this test that they have a ‘normal' result. It also says that men are recommended to get their PSA checked every year, which is not true. The NHS says there's currently no national screening programme for prostate cancer in the UK because the PSA test is not always accurate.”
So it's not the test itself that is being challenged, but its compliance with current NHS guidelines. We will continue campaigning for access to GP-based PSA tests and, in the meantime, draw your attention to advances in imaging for prostate cancer screening.
This year saw the publication of an initial cohort study for Prostagram, which demonstrated that a short, non-contrast MRI might have favourable performance characteristics as a community-based screening test, potentially leading to a world where men undergo Prostagram screening for prostate cancer as regularly and routinely as women undergo mammogram screening for breast cancer.
Results from the study showed that Prostagram picked up twice as many prostate cancers compared to the standard PSA test. The investigating team said:
“The Prostagram study opens up a new chapter in the screening, diagnostic and treatment pathway for prostate cancer. Precision screening will improve the detection process, increasing diagnosis of clinically significant disease and reducing unnecessary detection of insignificant disease. It's likely that focal therapy will emerge as a preferred alternative to surgery and radiotherapy for many men with localised prostate cancer. The other exciting consequence of an image-based screening programme could be the acceleration of AI-supported reporting systems for both MRI and pathology. This will provide the framework and free time for radiologists and pathologists to provide image-based reports to help guide treatment planning.”
Diagnostic Imaging and reporting
mpMRI for the prostate is constantly advancing through clinical research and clinical practice. As Prof Hashim Ahmed of Imperial College, a world leader in this research, commented recently,
“mpMRI misses very few cancers and is of questionable clinical significance when it does.”
Recent studies confirm this and give clinicians more confidence in the adoption of mpMRI and its enhancement with contrast agents.
Further attempts to standardise mpMRI practice across health centres based on these performance levels will ensure that more men will have access to the highest-quality imaging in the future.
Advancements in imaging at both screening and diagnostic levels are leading to more research and innovation in artificial intelligence and machine learning, which will support the inevitable increase in scale across the population. Technologies under development at Lucida Medical, Qantib, and Siemens Healthineers look promising.
Biopsies and Histology
As imaging advances through new technology, so does the accuracy of biopsies under the MRI/US fusion method, which accurately links biopsy samples to targeted regions of interest.
As discussed in a recent blog, histology is also improving through new approaches and technology, leading to improvements in consistency and accuracy.
New focal ablation technologies emerging
Three new approaches to focal therapy are emerging:
Avenda
This US-based company has developed technology that uses a laser to ablate cancerous tissue in the prostate. According to its founder, Shyam Natarajan:
“Avenda Health was founded, with support from a National Cancer Institute grant, to usher in the future of prostate cancer treatment. The company's technology and device system, which are being developed to treat only the tumour in the prostate – a similar approach to a lumpectomy for breast cancer – uses imaging, artificial intelligence (AI) and laser ablation. Using a large database of cancer imaging and pathology, in conjunction with a patient's own clinical information, a cancer probability map and treatment plan is created to calculate precisely where treatment should be applied, preserving the nerves around the prostate and the urethra”.
The technology has recently been given clearance from the FDA, the American regulator, which has designated it a ‘breakthrough device for the ablation of prostate tissue in patients with localized, favourable intermediate-risk prostate cancer. Its founder says that:
“Unlike other similar options in development, this approach will offer patients a personalized treatment plan through the use of the AI-based software and allow treatment to be performed in-office using local anaesthesia. This minimally invasive and local treatment will not impact the possibility for additional future treatment options, if needed, for particular patients."
TULSA
The word 'TULSA' stands for Transurethral Ultrasound Ablation. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperatures to ablate targeted prostate tissue. The procedure is performed in a Magnetic Resonance Imaging (MRI) suite and uses the TULSA PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of whole-gland or partial prostate tissue.
Irreversible Electroporation (IRE)
Irreversible electroporation (IRE) is a newly developed non-thermal tissue ablation technique in which short-duration electrical fields are used to form permanent nanoscale defects in the cell membrane, which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.
Early results by its German developers show promising outcomes based on limited data.
- Following IRE treatment of prostate cancer, no residual cancer was found in 23 of 28 (82%) of study participants at 6 months after targeted prostate biopsy.
- Prostate-specific antigen levels decreased from 8.65 ng/mL to 2.35 ng/mL at 12 months (P < .001) following IRE of the prostate.
- IRE of the prostate was associated with a leak-free and pad-free continence rate of 96.3% and stable urogenital function at 12 months.
All of the technology developments discussed here are very exciting and are driving focal therapy forward so that more men can benefit from it. What we haven't talked about here is the timeframes for development and barriers to adoption, which are all very critical to when, where, which, and how patients benefit from these emerging technologies. We are fortunate that TFTC clinicians are involved in the investigation of several of these developments through research and clinical trials, so we are keeping on top of advances and will continue to update our patient community. Watch this space.
Have you experience with new technologies in prostate cancer management? Do these advances give you confidence for the future? We'd love to hear from you.
