SUMMARY: Prostate cancer is the most common cancer in American men with the exclusion of skin cancer, and 1 in 8 men will be diagnosed with prostate cancer during their lifetime. It is estimated by the American Cancer Society that in the United States, about 313,780 new cases of prostate cancer will be diagnosed in 2025 and 35,770 men will die of the disease. The development and progression of prostate cancer is driven by androgens. Androgen Deprivation Therapy (ADT) or testosterone suppression has therefore been the cornerstone of treatment of advanced prostate cancer and is the first treatment intervention.
Prostate cancer treatment has traditionally revolved around whole-gland procedures, primarily radical prostatectomy, which, while effective in cancer eradication, is often associated with significant adverse effects, including urinary incontinence, erectile dysfunction, and the absence of semen. However, advancements in focal therapy, particularly Primary Partial-Gland CryoAblation (PPGCA), present a promising alternative that mitigates these consequences while maintaining efficacy. Primary Partial-Gland Cryoablation is a minimally invasive treatment for prostate cancer that involves the focal application of ultra‐cold temperature that destroys only the cancerous part of the prostate gland by freezing and thawing the cancerous cells.
The introduction of multiparametric Magnetic Resonance Imaging (mpMRI) has significantly improved our ability to determine the size, location, and aggressiveness of prostate cancer, enabling better candidate selection for focal therapy.
To rigorously assess the effectiveness of PPGCA, a study conducted at NYU Langone Health between May 2017 and March 2024, enrolled 313 men diagnosed with intermediate-risk prostate cancer, with no out-of-field Gleason grade group 2 or more, gross extracapsular extension, or extreme apical disease on pre-treatment mpMRI. Of these, 91 patients were followed for at least five years to evaluate the long-term efficacy of PPGCA. An intensive follow-up regimen was implemented. Patients underwent PSA testing every six months and received mpMRIs at 6-12, 24, 42, and 60 months post-treatment. Initially, protocol biopsies were conducted at 6-12 and 24 months; however, these were discontinued after interim analysis revealed a low incidence of clinically significant Prostate Cancer (csPCa) recurrence, defined as Gleason grade group 2 or more disease. The Primary end point was Freedom-from-failure, defined as no prostate cancer-specific mortality, metastatic disease, or whole-gland salvage treatment.
Key Findings
Among the 91 patients monitored for at least five years:
- Clinically significant Prostate Cancer (csPCa) was detected in 33 (10.5%) patients.
- The freedom-from-recurrence rates at five years were:
- In-field csPCa: 86%
- Out-of-field csPCa: 85%
- Overall csPCa: 70%
- The overall freedom-from-failure rate at five years was 89%.
- No patient succumbed to prostate cancer during the study period.
- One patient (1%) developed metastatic disease.
- 15 patients (16.5%) underwent whole-gland salvage treatment.
- 15 patients (16.5%) received salvage focal therapy.
- Patient compliance with the five-year surveillance protocol was exceptionally high, with only three patients (3.3%) deviating from scheduled monitoring.
Clinical Implications and Future Directions
The researchers emphasized that intermediate-risk patients were selected because, under conventional treatment paradigms, they would have been recommended for immediate whole-gland removal. The study suggests that 80% of men diagnosed with intermediate-risk prostate cancer may opt for focal cryotherapy over prostatectomy if given the choice, based on the effectiveness of treatment and reduced side effects.
The authors highlighted the comprehensive nature of this research, marking it as the largest prospective study of intermediate-risk prostate cancer treated with PPGCA. They reiterated the importance of rigorous follow-up and high patient compliance in ensuring accurate outcome assessment. As the study cohort matures, researchers aim to expand their evaluations to include lower-risk patients, who may not qualify for active surveillance but could benefit from less invasive alternatives to whole-gland treatment.
In conclusion, the current study demonstrated that PPGCA can effectively prevent cancer recurrence while avoiding the significant functional side effects of whole-gland removal. This study underscores the efficacy and feasibility of PPGCA as a viable alternative to prostatectomy, demonstrating very encouraging intermediate-term oncological outcomes. The high compliance rate with a rigorous surveillance protocol reinforces the potential of focal therapy in preserving quality of life while maintaining robust cancer control. Future research will focus on refining patient selection criteria and further validating long-term oncological and functional outcomes.
Five-year Oncologic Outcomes Following Primary Partial Gland Cryo-ablation Prospective Cohort Study of Men With Intermediate-risk Prostate Cancer. Lepor H, Rapoport E, Tafa M, et al. Urology. 2025 Feb;196:189-195.
