Efficacy and Safety of MRI-Guided Trans-Perineal Cryoablation for Treating Primary Prostate Cancer: A Prospective Study

Tuesday, April 1, 2025

3:27 PM – 3:36 PM CT

Location: Music City Center, 204

Presenting Author(s)

Setayesh Sotoudehnia Korani, MD

Postdoctoral Research Fellow
Mayo Clinic, United States

Author/Co-author(s)

LM

Lance A. Mynderse, MD, MS

Associate Professor in Urology & Radiology
Mayo Clinic, United States
Scott M. Thompson, MD, PhD (he/him/his)

Associate Professor of Radiology
Radiology, Mayo Clinic, United States
AL

Aiming Lu, PhD

Assistant Professor of Physics
Mayo Clinic, United States
AG

Ali Ganjizadeh, MD

Research Fellow
Mayo AI Lab, Radiology Department, Mayo Clinic, United States
DA

Daniel Adamo, MD

Assistant Professor of Radiology
Mayo Clinic, United States
David A. Woodrum, MD, PhD, FSIR (he/him/his)

Professor of Radiology
Mayo Clinic, United States

Purpose: To evaluate the incidence of biopsy-confirmed recurrences and adverse events in patients with native prostate cancer treated with MRI-guided trans-perineal focal cryoablation.

Materials and Methods: In this prospective study, approved by the Institutional Review Board (IRB), 100 patients diagnosed with primary prostate cancer underwent 1.5T MRI-guided trans-perineal cryoablation from December 2020 to April 2024. The procedure on average involved the use of four cryoneedles (ranging from three to six cryoneedles) with typically three freeze/thaw cycles. A urethral warmer was used to protect the urethra. T2-weighted MRI sequences (~20 sec) were used to monitor iceball expansion and target coverage. Post-ablation follow-up consisted of serum PSA every three months, prostate multi-parametric MRI every 6 months, and a follow-up biopsy at 1-2 years post-ablation. Additionally, the impact on patients' urinary symptoms and sexual health was measured using the American Urological Association Symptom Score (AUASS) with assessments at 6 and 12 months post-ablation.

Results: Trans-perineal MRI-guided cryoablation was performed on 100 male patients, with a mean age of 68 years (52-83) and a mean Body Mass Index of 30.41 (21-44), all with biopsy-proven primary prostate cancer. The average target lesion size was 1.46 cm (0.2-5.3 cm). A total of 63 patients have completed their one-year post-ablation follow-up, including imaging and biopsy. At the one-year follow-up, 63 patients showed significant reductions in PSA levels compared to pre-ablation values. PSA reductions were as follows: at 3 months (59.51% ± 36.12; p < 0.0001), 6 months (60.06% ± 25.82; p < 0.0001), and 12 months (56.79% ± 27.37; p < 0.0001). AUASS data suggested that urinary symptoms, including stream strength, urgency, incomplete emptying, and hesitancy, remained in the mild category throughout follow-up. At the one-year follow-up, biopsies indicated that 7 of 63 (11.1%) patients had cancer recurrence, with 6 of 7 (9.5%) demonstrating in-field recurrence and 1 of 7 (1.6%) showing an out-of-field recurrence in another region of the prostate. Erectile function worsened in 14% of patients, with 14 out of 100 requiring treatment for erectile dysfunction, predominantly managed with Viagra or Cialis. One patient reported perineal pain at 6 months post-procedure, which resolved with steroids and antibiotics.

Conclusion: MRI-guided trans-perineal focal cryoablation is a promising treatment that combines the precision of cryoablation with the superior soft tissue resolution and ablation monitoring capabilities of MRI.