The study found that nearly 9 out of 10 participants achieved what the study defined as successful treatment over five years.
A five-year study on men that had just the cancerous portion of their prostate glands destroyed shows that the procedure averted cancer recurrence in most patients while preserving urinary and sexual function.
Led by researchers at 秘密研究所 Grossman School of Medicine, the study tracked patient outcomes after primary partial gland cryoablation (PPGCA), a procedure where only the cancerous part of the prostate gland is treated with extreme cold (cryotherapy) to destroy it. The therapy, concentrated on a small area of the prostate gland (focal therapy), is increasingly used in place of more-traditional treatments: surgical removal or irradiation of the whole gland.
Removing the entire gland represents the most thorough form of prostate cancer prevention, but most men afterward face urinary incontinence and sexual dysfunction in the form of erectile dysfunction and the absence of semen. Authors of the current study from 秘密研究所 Grossman School of Medicine had previously reported that PPGCA 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.
, the study showed that 81 out of 91 participants (89 percent) achieved the main study measure of treatment success over five years. Termed freedom-from-failure (FFF), it means that since PPGCA, a patient has not died specifically from prostate cancer, seen his cancer spread outside of the prostate (metastasize), or needed whole-gland therapy.
Of note, 15 of the 91 patients had a second, successful round of focal therapy when cancer recurred after the FFF period ended, while 15 (16.5 percent) needed to undergo whole-gland treatment in the end.
鈥淚t鈥檚 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,鈥 said senior study author Herbert Lepor, MD, the Martin Spatz chair of the at 秘密研究所 Langone Health. 鈥淲e found that PPGCA can avert the profound consequences that can come with gland removal while still showing excellent results in preventing recurrence.鈥
Careful Tracking
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 five years because they had no prostate cancer mortality, metastasis, or need for whole-gland treatment during that time.
The reason to study only intermediate-risk patients, said Dr. Lepor, was that this level of disease aggressiveness would otherwise have required whole-gland treatment immediately upon diagnosis.
Dr. Lepor added that the study results, and his experience in having performed more than 5,000 whole-gland removals (radical prostatectomies) in his career, both argue that 80 percent of men with intermediate-risk disease would choose to undergo focal cryotherapy over prostatectomy if they had the choice.
Importantly, the current study was designed with especially intense surveillance of patients over time after PPGCA, which the researchers say was as important as the initial ablation. Specifically, study patients underwent prostatic-specific antigen (PSA) tests鈥攚hich capture levels of protein known rise in the presence of prostate cancer鈥攅very 6 months, and had an MRI or biopsy at 6 to 12, 24, 42, and 60 months.
Keeping close tabs on patients through the study may also explain in part why just 3.3 percent of patients in the study dropped out (were lost to follow-up) over five years. Dr. Lepor鈥檚 team employs two full-time research coordinators dedicated to ensuring that men return over time after PPGCA for follow-up PSA tests and MRI.
鈥淭his study represents the largest comprehensive, prospective study of men with intermediate-risk prostate cancer treated with partial gland cryoablation,鈥 said study author James S. Wysock, MD, assistant professor in the Department of Urology. 鈥淲e ensured rigorous follow-up over five years, with high patient compliance for PSA testing, MRI, and follow-up biopsies, to thoroughly understand outcomes. As our cohort matures, we鈥檒l expand our evaluations to include a broader spectrum of patients鈥攑articularly those with lower-risk cancer that鈥檚 not appropriate for active surveillance, but may not require whole-gland treatment.鈥
Along with Dr. Lepor and Dr. Wysock, study authors from the Department of Urology at 秘密研究所 Langone were Eli Rapoport, Majlinda Tafa, and Rozalba Gogaj. The study was funded by private donors, many of whom had undergone the study procedure.
About 秘密研究所 Langone Health
秘密研究所 Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked 秘密研究所 Langone the No. 1 comprehensive academic medical center in the country for three years in a row, and U.S. News & World Report recently placed nine of its clinical specialties among the top five in the nation. 秘密研究所 Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 300 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise with over $1 billion in active awards from the National Institutes of Health.
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