What do you tell patients that opt for High-intensity focused ultrasound (HIFU) for favorable intermediate risk prostate cancer over AS (Active Surveillance), RP (Radical Prostatectomy), EBRT (External Beam Radiation Therapy), or brachy?
Urology and radoncs differ in their approach to this. Recent (inflammatory) social media discussions have shown this.
There are limited prospective data on focal therapies versus whole-gland approaches, but the retrospective data should give us all pause.
What we do know:
- HIFU has significant toxicity, and it appears that it is worse than EBRT. If you look at the outcomes data from a SEER database analysis (thanks, Dr. James Yu and colleagues). GU toxicity, erectile dysfunction, and incontinence are all worse with focal therapy. GI toxicity appears to be less with focal therapy. The problem is not that it has toxicity - it is that the marketing says that it is less toxic and the data does not support this.
- The cure rates are below what we ...
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I often call focal therapy the 'aggressive surveillance' regimen. Perhaps in some hands, in some patients, it is less toxic than RT or RP. Perhaps it has lower subsequent treatment rates than 'any treatment' rates seen with AS.
There certainly are patients for whom I recommend AS, and they still want treatment. Seeing a friend or family member die of metastatic disease can be hard to shake. I can name multiple patients who are more likely to have RT tox: very large glands, high IPSS, IBD, etc. Some of these are more likely to have RP tox too (e.g., a 250 cc gland is going to have a rough time...). However, in, say, an 80 yo who declines AS/WW with IBD and LUTS refractory to flomax and finasteride, I hope focal helps him sleep better at nigh...
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There are currently no published trials that specifically address this question, which is a very good one.
My general discussion is that ablation therapies (not specifically HIFU) will have less negative impact on quality of life factors such as preserving erectile function, avoiding urinary incontinence, and avoiding bowel function disruption than treatments like surgery or radiation therapies. When compared to active surveillance, there are data that ablation prolongs the time to progression of disease and reduces AS-related anxiety, but may have some negative impact on quality of life that needs to be balanced with benefits. For the favorable intermediate-risk population, there is not really a right answer, so I try to empower the patient...
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The data on focal therapy is becoming more mature, helping guide conversations with patients. It is consistently shown that the risk of progression after focal therapy rises as grade increases. In one series:
- Grade group 2 (n≈870): failure-free survival 86.5% at 24 months, 60.5% at 60 months
- Grade group 3 (15.6% of cohort): FFS 77.8% at 24 months, 37.4% at 60 months
A more recent publication, which did not break down by Gleason score, found around a third of FIR and half of UIR needed further focal treatment by 10 yrs. The cumulative incidence of all further therapy (including transitioning to RT or RP) was not described. The number of treated lesions and location of disease also appear predictive, with anterior and base lesions at higher r...
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HIFU still requires surveillance biopsy periodically. Salvage therapy after HIFU also has high toxicity. AS or radical prostatectomy has the lowest toxicity among these options.
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I tell patients that most often prostate cancer is multifocal and sometimes multicentric, with most of the danger coming from the index lesion (Mouraviev and Polascik, PMID 21935343). "Unifocal tumors were found in 22% of all cases versus 78% identified with multifocal disease, with a mean of 2.24 cancer foci. The mean index tumor volume was 2.42 cc, and the mean total accessory tumor volume was 0.61 cc." Thus, partial gland treatment is not without risk of failure. While the gland is small, its pathology is complex and often has microscopic areas that impart a worse prognosis.
In addition, I say it is an operator-dependent procedure that relies on the surgeon's skill and appropriate selection of patients; the stellar statistics they hear fr...
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