A 5-year study on men that had primary partial-gland cryoablation shows that the procedure averted cancer recurrence in most patients while preserving urinary and sexual function.
Led by researchers at New York University Grossman School of Medicine, the study tracked the patient outcomes after primary partial-gland cryoablation, a procedure during which only the malignant part of the prostate gland is treated with cryotherapy to destroy it. Focal therapy such as this is increasingly used in place of the traditional whole-gland prostate cancer treatments such as prostatectomy or irradiation of the entire gland.
Prostatectomy offers the most thorough form of prostate cancer prevention, but most men will experience urinary incontinence and sexual dysfunction in the form of erectile dysfunction, and the absence of semen. Authors of the current study had previously reported that primary partial-gland cryoablation avoids incontinence and minimizes sexual dysfunction. Despite the potential of focal therapy, no study had yet tracked the effectiveness of the combination of partial-gland ablation with intense follow-up to watch for, and immediately address, any recurrence.
About the Study
Published recently in the journal Urology, the study showed that 91 participants (89%) achieved the main study measure of treatment success, freedom-from-failure.
“It’s worth considering that the need to take out the whole gland was judged to be treatment failure in our study even though nearly all of these men, before the advent of partial-gland removal, would have had the whole-gland procedure,” said senior study author Herbert Lepor, MD, the Martin Spatz Chair of the Department of Urology at NYU Langone Health. “We found that [primary partial-gland cryoablation] can avert the profound consequences that can come with gland removal while still showing excellent results in preventing recurrence.”
Herbert Lepor, MD
Advances in magnetic resonance imaging (MRI) enabled the team to reliably identify the sites, and aggressiveness, of cancer, which in turn determined the best candidates for focal therapy. Between May 2017 and March 2024, 313 men with MRI-determined, intermediate-risk prostate cancer were found to meet the study inclusion criteria. Of those, 91 could be evaluated for freedom-from-failure over the entire 5 years.
Results
At 5 years, rates of freedom-from-recurrence of in-field, out-of-field, and overall clinically significant prostate cancer were 86%, 85%, and 70%. The proportion with freedom-from-failure at 5 years was 89% (95% confidence interval [CI] = 83%–95%). None died from prostate cancer, 1 (1%) developed metastasis, 15 (16.5%) underwent whole-gland salvage treatment, and 15 (16.5%) underwent salvage focal therapy.
Only intermediate-risk patients were studied because this level of disease aggressiveness would otherwise have required whole-gland treatment immediately upon diagnosis, said Dr. Lepor noted.
He added that the study results, and his experience in having performed more than 5,000 radical prostatectomies in his career, both argue that 80% of men with intermediate-risk disease will chose to undergo focal cryotherapy over prostatectomy if they have the choice.
Intense Surveillance
Importantly, the current study was designed with especially intense surveillance of patients over time after focal therapy, which the researchers say was as important as the initial ablation. Study patients underwent prostatic-specific antigen (PSA) tests, every 6 months, and had an MRI or biopsy at 6 to 12, 24, 42, and 60 months.
James Wysock, MD
“This study represents the largest comprehensive, prospective study of men with intermediate-risk prostate cancer treated with partial-gland cryoablation,” said James Wysock, MD, another author of the study and Assistant Professor in the Department of Urology at NYU Langone. “We ensured rigorous follow-up over 5 years, with high patient compliance for PSA testing, MRI, and follow-up biopsies, to thoroughly understand outcomes. As our cohort matures, we’ll expand our evaluations to include a broader spectrum of patients—particularly those with lower-risk cancer that’s not appropriate for active surveillance, but may not require whole-gland treatment.”
Disclosure: The study was funded by private donors, many of whom had undergone the study procedure. For full disclosure of all study authors, visit www.goldjournal.net.
REFERENCE
1. Lepor H, Rapoport E, Tafa M, et al: Five-year oncologic outcomes following primary partial gland cryo-ablation prospective cohort study of men with intermediate-risk prostate cancer. Urology 196:189-195, 2025.
