MRI-guided HIFU effective for medium-risk prostate cancer

Researchers report that MRI-guided high-intensity focused ultrasound (HIFU) is effective in patients with moderate-risk prostate cancer.

According to a multicenter, single-group, phase IIb study of a team of 101 treated patients, 96% had grade group 2 or higher on a systematic biopsy of 6-month MRI. There was no evidence of prostate cancer. Behfar Ehdaie, MD and his colleagues at the Memorial Sloan-Kettering Cancer Center in New York City, mentioned the prostate.

Similarly, the 24-month results showed no evidence of grade group 2 or higher disease in 88% of 89 patients, the researchers reported. Lancet Oncology..

They also have few side effects from HIFU focus therapy, and quality of life results are “very well compared” with results from studies of whole-glandular therapies such as radical prostatectomy and radiation therapy. I found.

“These results are in a controlled trial to determine whether topical therapy for selected patients and a tissue preservation approach are effective in delaying or eliminating the need for radical whole-glandular treatment in the long term. We support its use, “the team wrote.

The study was conducted at eight medical centers in the United States and included men over the age of 50 with unilateral, MRI-visible, primary, medium-risk, and untreated prostate adenocarcinoma (prostate-specific antigen). [PSA] ≤20 ng / mL, grade group 2 or 3; tumor classification ≤ T2) was confirmed with a systematic biopsy combination for MRI.

All patients underwent biopsy 6 and 24 months after the procedure, and oncological efficacy was defined as the absence of grade 2 or higher cancer at those time points.

Other results of the study are:

• 76% of men are 6 months old, 60% are 24 months old, and there is no evidence of grade group 2 or higher cancer anywhere in the prostate.

• At a 6-month biopsy, 19 of 101 men newly detected grade group 2 or higher cancer only outside the treatment area.

• PSA decreased 6 months after treatment (mean decrease -3.0 ng / mL, 95% CI -3.6 to -2.4) and slightly increased 24 months (-2.6 ng / mL, 95% CI-). 3.3 to -2.0).

Quality of life / adverse events

The erectile function score, measured by the international index of erectile function, was slightly worse at 24 months than baseline (-3.5, 95% CI -5.4 to -1.6). Average sexual satisfaction (-1.8, 95% CI -2.9 to -0.8), and overall satisfaction score (-0.8, 95% CI -1.3 to -0.3) also deteriorated slightly in 24 months.

“The difference in mean erectile function score was significant, but the slight difference is interpreted throughout the overall score range and is considered over a two-year period in which a slight decrease in erectile function score is expected without treatment. It should. It changes statistically, but it is not clinically significant. “

“These functional outcomes are compared very favorably with patient-reported outcomes after total glandular treatments such as radical prostatectomy and radiation therapy. These are effective but affect quality of life. Is associated with substantial and persistent side effects that give, “the researchers added.

Regarding lower urinary tract symptoms, “most patients reported moderate or mild lower urinary tract symptoms at baseline and throughout the study period,” reporting urinary incontinence requiring pad use at 24 months. There were no patients.

There were no serious treatment-related adverse events (AEs) observed during the study period. A single grade 3 urinary tract infection related to the device or procedure was reported and resolved within 3 days.

Typical grade 2 or lower AEs included hematuria in 24% of patients and urinary retention in 15%.

Ehdaie et al. Stated that the limitations of the study included that a 24-month biopsy was not a sufficient surrogate endpoint for metastasis or cancer-specific mortality. “But the purpose of this study was to evaluate whether MRI-guided focused ultrasound focus therapy could avoid whole-gland therapy based on post-treatment biopsy results. An annual study. “Period,” the researchers pointed out.

They also have a long-term clinical benefit of treating men with medium-risk prostate cancer rather than being followed up with AS because there is no randomized comparison group of men in active surveillance (AS). He said it was impossible to estimate.