Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study

Abstract

SummaryBackgroundRadical whole-gland therapy can lead to significant genitourinary and rectal side-effects for men with localised prostate cancer. We report on whether selective focal ablation of unifocal and multifocal cancer lesions can reduce this treatment burden.MethodsMen aged 45–80 years were eligible for this prospective development study if they had low-risk to high-risk localised prostate cancer (prostate specific antigen [PSA] ≤15 ng/mL, Gleason score ≤4 + 3, stage ≤T2), with no previous androgen deprivation or treatment for prostate cancer, and who could safely undergo multiparametric MRI and have a general anaesthetic. Patients received focal therapy using high-intensity focused ultrasound, delivered to all known cancer lesions, with a margin of normal tissue, identified on multiparametric MRI, template prostate-mapping biopsies, or both. Primary endpoints were adverse events (serious and otherwise) and urinary symptoms and erectile function assessed using patient questionnaires. Analyses were done on a per-protocol basis. This study is registered with ClinicalTrials.gov, number NCT00561314.Findings42 men were recruited between June 27, 2007, and June 30, 2010; one man died from an unrelated cause (pneumonia) 3 months after treatment and was excluded from analyses. After treatment, one man was admitted to hospital for acute urinary retention, and another had stricture interventions requiring hospital admission. Nine men (22%, 95% CI 11–38) had self-resolving, mild to moderate, intermittent dysuria (median duration 5·0 days [IQR 2·5–18·5]). Urinary debris occurred in 14 men (34%, 95% CI 20–51), with a median duration of 14·5 days (IQR 6·0–16·5). Urinary tract infection was noted in seven men (17%, 95% CI 7–32). Median overall International Index of Erectile Function-15 (IIEF-15) scores were similar at baseline and at 12 months (p=0·060), as were median IIEF-15 scores for intercourse satisfaction (p=0·454), sexual desire (p=0·644), and overall satisfaction (p=0·257). Significant deteriorations between baseline and 12 months were noted for IIEF-15 erectile (p=0·042) and orgasmic function (p=0·003). Of 35 men with good baseline function, 31 (89%, 95% CI 73–97) had erections sufficient for penetration 12 months after focal therapy. Median UCLA Expanded Prostate Cancer Index Composite (EPIC) urinary incontinence scores were similar at baseline as and 12 months (p=0·045). There was an improvement in lower urinary tract symptoms, assessed by International Prostate Symptom Score (IPSS), between baseline and 12 months (p=0·026), but the IPSS-quality of life score showed no difference between baseline and 12 months (p=0·655). All 38 men with no baseline urinary incontinence were leak-free and pad-free by 9 months. All 40 men pad-free at baseline were pad-free by 3 months and maintained pad-free continence at 12 months. No significant difference was reported in median Trial Outcomes Index scores between baseline and 12 months (p=0·113) but significant improvement was shown in median Functional Assessment of Canc...

The role of magnetic resonance imaging in the diagnosis and management of prostate cancer

“…Medium to long-term outcomes of modern techniques are not yet available [130,131], but short-term outcomes appear favourable for selected men in recent studies [132], especially those where mpMRI was used together with template mapping biopsy [133]. The key to a successful outcome with focal therapy lies in the accurate localisation and risk stratification of all foci of clinically significant cancer.…”

Morphological analysis of the effects of intraoperative transrectal compression of the prostate during high‐intensity focused ultrasound for localized prostate cancer

“…[9][10][11][12][13] In previous studies, complications reported included the rate of bladder outlet obstruction, urinary incontinence and erectile dysfunction, and their incidence was 0-5.0%, 0-10% and 5.0-6.0%, respectively.…”

For localized prostate cancer, does technology equal progress?

“…Proton-beam prostate treatment fortunately remains uncommon, but new facilities are proliferating rapidly, and because once a facility is constructed there is a major incentive to recoup a prodigious investment, local prostate cancer practice patterns tend to shift to reflect more use of proton-beam treatment. 7 The other recent paper, from Ahmed et al, 8 reported MRI-guided focal treatment with high-intensity focused ultrasound www.nature.com/nrclinonc NEWS & VIEWS (HIFU). HIFU has been the subject of multiple series, mostly in Europe.…”

“…Ahmed et al 8 reported on 42 men with low-risk to intermediate-risk prostate cancer treated with HIFU targeting areas of cancer based on biopsy and imaging. The protocol allowed up to 60% ablation of the prostate, and required transperineal template prostate biopsies under anaes thesia before and after therapy.…”

“…What is novel about this study 8 is not HIFU per se, but rather its use in a relatively well-constructed, prospective study of focal therapy. Indeed, for focal prostate cancer treatment, the ablative technology is almost irrelevant.…”