'Male Lumpectomy' for Prostate Cancer Is Safe and Effective

Small Study

Yael Waknine

April 19, 2012

April 19, 2012 — Selective ablation using high-intensity focused ultrasound is a safe and effective method of treating localized prostate cancer, a small study published online April 17 in the Lancet Oncology suggests.

The experimental treatment, dubbed male lumpectomy, is similar in principal to breast-conserving surgery as an alternative to mastectomy in breast cancer.

The researchers studied men treated at University College London Hospitals NHS Foundation Trust (UCLH) and University College London (UCL), United Kingdom. None of the 41 men suffered urinary incontinence, which typically affects 5% to 20% of patients undergoing radical whole-gland surgery or radiotherapy that inflicts damage on surrounding healthy tissue.

The majority of men (90%) reported satisfactory erections for intercourse at 1 year; erectile dysfunction affects 30% to 70% of those who undergo conventional treatment. Moreover, 95% of men were cancer-free at 1 year.

This trifecta (no urine leakage, good erections, and cancer control) was achieved by 89% of men treated with focal therapy at 1 year, compared with 50% of those treated with surgery or radiotherapy.

"Our results are very encouraging. We're optimistic that men diagnosed with prostate cancer may soon be able to undergo a day-case surgical procedure, which can be safely repeated once or twice, to treat their condition with very few side effects. That could mean a significant improvement in their quality of life," write the authors, led by Hashim U. Ahmed, MD, from the UCL.

"This study provides the proof-of-concept we need to develop a much larger trial to look at whether focal therapy is as effective as the current standard treatment in protecting the health of the men treated for prostate cancer in the medium and long term," the investigators add.

Excellent Outcomes

The researchers used magnetic resonance imaging (MRI) and mapping biopsies to pinpoint the exact location of the cancer lesion(s) — a feat that cannot be achieved using standard transrectal biopsy.

The men then underwent focal ablation with transrectal high-intensity focused ultrasound, which destroys cancerous tissue, using both physical and thermal means, in areas as small as a grain of rice.

Of the 41 men, 20 (49%) had unilateral 1-area ablation, 15 (37%) had bilateral 2-area ablation, and 6 (15%) had midline 1-area treatment. Thirty men (73%) stayed in the hospital for less than 24 hours.

With respect to adverse events, 9 men (22%; 95% confidence interval [CI], 11 to 38) developed urinary debris that lasted a mean of 14.5 days (interquartile range [IQR], 6.0 to 15.5 days), and 7 (17%, 95% CI, 7 to 32) developed a self-resolving urinary tract infection.

The median overall score on the 15-item International Index of Erectile Function did not change significantly from baseline (P = .060), nor did median scores for intercourse satisfaction (P = .454), sexual desire (P = .644), or overall satisfaction (P = .257). Of the 35 men with good baseline function, 31 (89%; 95% CI, 73 to 97) had erections capable of penetration at 1 year.

Urinary incontinence at 1 year, evaluated using the Expanded Prostate Cancer Index Composite, was also similar to baseline (P = .045). In addition, lower urinary tract symptoms, assessed using the International Prostate Symptom Score, improved (P = .026). All 40 men who were pad-free at baseline had recovered by 3 months, and maintained continence at 1 year.

At 6 months, no histologic evidence of cancer was identified in 30 of 39 biopsied men (77%; 95% CI, 61% to 89%). After retreatment in 4 men, 39 of 41 (95%; 95% CI, 83% to 99%) had no evidence of disease on MRI at 1 year.

"Focal therapy offers harm reduction. It is a strategy that attempts to redress the balance of harms and benefits by offering men who place high utility on genitourinary function an alternative to standard care. In fact, the concept is not new — tissue-preserving strategies have been used successfully in all other solid organ cancers, such as breast cancer by offering women a lumpectomy rather than mastectomy," said Mark Emberton, MD, program director at UCL and UCLH, in a British Medical Research Council (MRC) news release.

Gillies McKenna, MD, PhD, director of the MRC/Cancer Research UK Gray Institute for Radiation Oncology and Biology, praised the concept, noting that if the results are confirmed in a randomized controlled trial, focal therapy could soon become a "reasonable treatment choice" for prostate cancer, alongside other proven effective therapies."

Some issues must be resolved first, write Matvey Tsivian, MD, and colleagues from the Duke University Medical Center in Durham, North Carolina, in an accompanying comment.

"Focal therapy needs standardization, definition of consensual treatment schemes and nomenclature, as well as optimization of patient selection criteria," they note.

To address these and other issues, investigators are currently recruiting patients for a 3-year multicenter phase 2 trial.

The Wave of the Future?

According to Dr. Tsivian, focal therapy has the potential to become a mainstream personalized therapy for localized prostate cancer, but might also lead to an entirely new framework for the diagnosis of prostate cancer.

He wonders: "What if imaging could represent a substitute for random histological sampling of the prostate? What if, upon suspicion of prostate cancer, we could undertake an imaging study that would guide the biopsy (similar to most other malignancies)? Would random biopsies become obsolete? Would the same imaging modality be able to diagnose, characterize, and guide the treatment of prostate cancer?"

"The urological and oncological communities have to be alert to this rapidly changing field of prostate cancer management, and specifically, focal therapy," Dr. Tsivian concluded.

The research was funded by the MRC, the Pelican Cancer Foundation, and St. Peter's Trust. Dr. Emberton and Dr. Ahmed report receiving funding from USHIFU (the manufacturer and distributor of the Sonablate 500 high-intensity focused ultrasound device), GlaxoSmithKline, Advanced Medical Diagnostics, Focused Surgery, Misonix, Oncura, and GE Healthcare; and being paid consultants to Steba Biotechand.

Lancet Oncol. Published online April 17, 2012. Abstract, Comment

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