TOPLINE:

A novel cooled laser focal therapy device demonstrates 84% treatment success for localized prostate cancer at 3 months, with only 12% reporting erectile dysfunction and minimal impact on urinary function.

METHODOLOGY:

• Patients with intermediate-risk prostate cancer typically undergo radical whole-organ therapies carrying high morbidity risks. Focal therapy represents an emerging field for prostate cancer treatment that targets cancer while sparing unaffected prostate tissue.
• Researchers recruited 100 men with localized prostate cancer, prostate-specific antigen (PSA) level < 15 ng/mL, stage < T2c, and International Society of Urological Pathology (ISUP) score 2-3 concordant with multiparametric MRI visible disease to receive cooled laser focal therapy with the ProFocal device (Medlogical Innovations, Sydney, Australia).
• Primary outcome measures included adequacy of tissue ablation assessed with multiparametric MRI within 72 hours and biopsy at 3 months post-treatment.
• Secondary outcomes evaluated functional measures through validated questionnaires including the International Prostate Symptom Score, Sexual Health Inventory for Men (SHIM), Expanded Prostate Cancer Index Composite (EPIC), and 12-Item Short-Form Health Survey.
• Treatment delivery utilized the transperineal route under general anesthesia as a day procedure, with real-time temperature monitoring at 60-100 °C.

TAKEAWAY:

• Patient demographics included a median age of 66 years (IQR, 60-72), a median PSA level of 5.9 ng/mL (IQR, 3.9-7.6), a median prostate volume of 39 mL (IQR, 30-51), and a median MRI lesion volume of 0.84 mL (IQR, 0.57-1.2).
• In all, 84% of patients had no ISUP Grade Group > 2 prostate cancer in their 3-month treatment zone biopsies.
• Functional outcomes revealed a 15% mean decline in SHIM and EPIC-sexual domain scores, with erectile dysfunction reported in 12% of men.
• Urinary function showed minimal impact with only a 4.5% decrease in EPIC-urinary domain scores, with no decline in other functional measures.

IN PRACTICE:

The trial “demonstrates the safety and efficacy of [prostate cancer] treatment with the [cooled laser focal therapy] device. Our study showed that [this device] provides similar oncological outcomes to existing literature on other [focal therapy] devices but with an improved safety profile with no fistulae and low rates of incontinence,” wrote the authors of the study.

SOURCE:

The study was led by Jonathan Kam, Nepean Hospital in Kingswood, Australia. It was published online in BJU International.

LIMITATIONS:

According to the authors of the study, the main limitations of the study included the absence of a control group and the short follow-up period of only 3 months, which may not fully reflect long-term outcomes.

DISCLOSURES:

Celi Varol disclosed being the founder and chief executive officer of Medlogical Innovations, which provided the ProFocal device for this clinical trial. Raymond Ko and Ahmed Saeed Goolam disclosed becoming stockholders of Medlogical Innovations after the trial completion.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.