There will be “routine application” and “wider acceptance” of minimally invasive focal therapies for the early stages Prostate cancer in the next 5 years in the United States, predict a trio of clinicians in a new trial published online July 28 to JAMA surgery.
They argue that focal therapy (FT) offers a “middle ground” between two extremes: treating the entire gland with prostatectomy or radiation therapy, and do not treat immediately with active surveillance or watchful waiting.
Focal therapy usually treats the primary lesion in the prostate, while leaving the rest of the gland intact. Most commonly performed by cryoablation or High Intensity Focused Ultrasound (HIFU), it can also be performed with a variety of technologies, including ultrasound transurethral ablation and focal laser ablation.
The move to focal therapy will coincide with the maturing of long-term data from studies using various technologies, predict the authors, led by Amir Lebastchi, MD, a urologist at the University of Southern California.
“Standard adoption of focal therapy ultimately depends on the availability of strong Level I evidence, which in turn will stimulate medical companies and beneficiaries,” the authors also write.
But recipients are already making changes, even without that data, they add.
For example, the American Medical Association announced in January a new code for High Intensity Focal Ultrasound (HIFU): this approach now has a Code of Current Procedural Terminology (CPT) from the Centers for Medicare & Medicaid Services. United States.
Medscape Medical News contacted Matthew Cooperberg, MD, MPH, urologist at the University of California, San Francisco (UCSF), for comment on the optimism of the trial; he has questioned focal therapy in the past due to a lack of strong evidence to support it.
I expect its use to actually increase over the next 5 years.
“While ‘routine’ is a bit of a loose term, now that HIFU has a CPT code, I expect its use to actually increase over the next 5 years,” Cooperberg wrote in an email. “The question is whether its use will increase appropriately. “
The challenge of focal therapy, regardless of the energy modality, remains the selection of the patient and the precise definition of the ablation area, he added.
Notably, UCSF launched a new HIFU program – and Cooperberg referred selected patients. “I am both excited and cautious about the future, and we need to monitor our results very closely in various practice settings,” he said.
While waiting for CHRONOS, select wisely
According to Derek Lomas, MD, PharmD, a urologist at the Mayo Clinic in Rochester, Minnesota, in an explanatory article. “This approach is widely accepted in other types of cancer. For example, we commonly treat kidney cancers by removing or eliminating only the tumor while leaving the rest of the kidney intact.”
However, some focal therapies also include approaches known as hemiablations, in which an entire half of the prostate is destroyed, and approaches that leave only a very small part of the gland.
Each of the modalities used for focal therapy has “unique indications, risks and benefits and uses a different energy source for ablation,” Lebastchi and colleagues write in their essay.
They claim that focal therapy can provide oncologic efficacy similar to radical prostatectomy or radiation therapy “while dramatically reducing or even eliminating functional morbidities, such as incontinence and blistering. erectile dysfunction. “
Overall, they say focal therapy offers an opportunity for improved care as there is “a growing body of emerging evidence demonstrating a favorable adverse reaction profile with oncologic control similar to whole gland treatment options. “.
What is this proof?
In the trial, Lebastchi and colleagues point to a number of single-arm studies with encouraging results in terms of efficacy and safety. They also highlight a phase 3 randomized trial in which they were involved: this compared focal therapy (partial ablation of the glands with targeted vascular photodynamic therapy) with active surveillance in the early stages of the disease, and a consistently showed better post-treatment biopsy (disease / freedom from disease) and results of conversion to prostatectomy with focal therapy for up to 4 years (J Urol. 2018; 200: 786-793).
However, this study did not have an active treatment comparator. For this gold standard, there is now an anticipation of the results of the CHRONOS in the UK, in particular Part A of the trial, which compares radical therapy to focal therapy (HIFU or cryotherapy), with 5-year progression-free survival as the primary endpoint. This trial is expected to end in 2027.
Until then, the lack of prospective randomized clinical trials and long-term follow-up “hampers acceptance [of focal therapy] in the urological community, ”commented the authors of the trial.
During this time, careful selection of patients is very important, they say.
The latest relevant guidelines indicate that suitable candidates are men with a solitary and well-defined index lesion; patients with bilateral multifocal lesions; or very advanced tumors which are not suitable for the focal approach.
A group of international multidisciplinary experts recently met to develop guidelines for clinicians offering focal therapies, and then published a consensus statement advise practitioners and researchers.
Cooperberg of UCSF sees a lot of room for improvement among focal therapy practitioners and researchers. “From a results perspective, monitoring protocols and definitions of success remain inconsistent. I think we are making progress in all of these areas, but we are not there yet, ”he said.
To date, some patients have been poorly managed, Cooperberg added. “We are certainly seeing many patients who have been insufficiently counseled on the pros and cons of HIFU, with sometimes disastrous results.”
Some of these unfortunate results may have been due to the initial approval of HIFU by the United States Food and Drug Administration in 2015, which was intended to be used for the ablation of prostate tissue in general and not the cancer in particular. This approval created confusion, commented an expert at the time: “The FDA does not say whether it is a mild or a malignant disease; it’s a bit vague, like saying you can drive that car but we’re not going to tell you how to drive it, ”said Manoj Monga, MD, of the Cleveland Clinic.
Lebastchi did not disclose any relevant financial relationship; co-author Inderbir Gill, MD, is an unpaid consultant for Steba Biotech and co-author Andre Luis Abreu, MD, is a consultant for Koelis and was a training supervisor for Steba Biotech. Cooperberg is a consultant for Alessa Therapeutics.
JAMA Surg. Published online July 28, 2021. Surgical innovation