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Nanoknife electroporation for the ablation of prostate tissue in intermediate-risk prostate cancer patients: Functional Outcomes from the PRESERVE trial
Jonathan S. Fainberg, MD MPH.
Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background: Irreversible electroporation (IRE) is a tissue ablation method using high-voltage electrical pulses to change cell membrane permeability, leading to cell death. PRESERVE (NCT04972097) evaluated the safety and effectiveness of the NanoKnife System to ablate prostate tissue in intermediate-risk prostate cancer (PCa). We report the study’s functional outcomes.
Methods: PRESERVE is a prospective, non-randomized trial which included 121 patients across 17 US centers meeting key inclusion criteria: age>50 with organ-confined PCa, clinical stage ≤T2c, prostate-specific antigen (PSA) ≤15 ng/mL or PSA density<0.15 ng/mL² if PSA>15 ng/mL, and Gleason score 3+4 or 4+3. Table 1 lists patient and procedure characteristics. Patient-reported outcomes were collected through 12 months post-IRE.Results: The urinary domain score of the UCLA-EPIC questionnaire showed a mean of 87 at baseline and improved 12-month score of 91 (Figure 1). UCLA-EPIC function, bother, irritative/obstructive, and incontinence subscales also showed mean score improvements from baseline to 12 months post-procedure (Figure 1). Among patients (81%) with functional baseline erections, 72% retained erections sufficient for penetration at 12 months (Figure 2). All subscales of the IIEF-15 questionnaire approached baseline scores at 12 months (Figure 2).Conclusions: PRESERVE demonstrates beneficial functional outcomes using the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. This device may provide an alternative to radical treatments while preserving functional outcomes.

					Table 1. Patient and Procedure Characteristics
		Characteristic								Study PopulationN=121
		Demographics
		Race [n (%)]					Asian			7 (5.8)
							Black or African American			10 (8.3)
							White			100 (82.6)
							Other			1 (0.8)
							Unknown			3 (2.5)
		Ethnicity [n (%)]					Hispanic or Latino			4 (3.3)
							Not Hispanic or Latino			110 (91)
							Not Reported			3 (2.5)
							Unknown			4 (3.3)
		Age at Informed Consent (years)					Mean (std)MedianQ1, Q3			67 (7)6761, 72
		Disease Characteristics
		AJCC Primary Tumor Stage at Screening [n (%)]					T1b			1 (0.83)
							T1c			103 (85)
							T2a			13 (11)
							T2b			4 (3.3)
		Grade Group at Screening [n (%)]					2			97 (80)
							3			24 (20)
		Lesion Regional Location [n (%)]					n			120
							Apex			49 (41)
							Base			18 (15)
							Midline			53 (44)
		Lesion Anterior/Posterior Location [n (%)]					n			120
							Posterior			70 (58)
							Anterior			50 (42)
		Procedure Characteristics
		Duration of Procedure (Minutes)					nMean (std)MedianQ1, Q3Min, Max			11654.1 (23.15)50.038.0, 63.518.0, 128.0
		Number of Probes Used					nMean (std)MedianQ1, Q3Min, Max			1214.3 (0.69)4.04.0, 5.03.0, 6.0
		Lesion Location Directionality Section 1					n			120
							Apex			49 (40.8)
							Base			18 (15.0)
							Midline			53 (44.2)
		Lesion Location Directionality Section 2					n			120
							Anterior			50 (41.7)
							Posterior			70 (58.3)
		Ultrasound/MRI Fusion Device During Procedure					n			121
							Yes			105 (86.8)
							No			16 (13.2)

AJCC = American Joint Committee on Cancer; PSA = prostate-specific antigen

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