Abstract
e537 Background: We report our mid-term oncologic and functional outcomes of focal cryo-hemiablation (FC-HA) for unilateral localized low-risk prostate cancer (PCa). Methods: Prospective single-arm interventional study analyzing mid-term data of PCa patients treated at our institution with FC-HA of diseased lobe. Inclusion criteria were men with unilateral localized cancer, PSA < 15 ng/ml, clinical stage T1c-T2a, Gleason score ≤ 7 (3+4), maximum number of cancer-cores < 33%, maximum cancer involvement in a single core < 50%, no extra prostatic extension in mp-MRI, no previous PCa-related treatment and life expectancy ≥10 yr. PSA was measured every 3 mo during 1st yr post treatment, and biannually thereafter. mp-MRI and biopsy of both lobes were routinely done at 12 mo, while repeat biopsies were driven by PSA elevations. Continence, urinary and erectile functions were assessed using ICS, IPSS and IIEF-5 questionnaires, respectively. Treatment failure (primary outcome) was defined as residual cancer in treated lobe at follow up. Results: We studied 52 men with mean (SD) age of 65.8 (7.2) yrs and median (IQR) follow-up of 31 (21-44) mo. Baseline criteria were: median (IQR) of PSA of 6.8 (5.4–8.0) ng/ml, total number of cancer-cores of 2 (1-3) and percentage cancer-cores of 17% (8-25), and total cancer-core length of 7 (3-12) mm. Gleason score was 6 (3+3) in 33 (63.5%) and 7 (3+4) in 19 (36.5%) patients. Follow-up biopsies were done in 1st, 2nd and 3rd yrs for 52 (100%), 28 (53.8%) and 15 (28.8%) patients, respectively, revealing cancer-cores in 13/52 (25%) patients. 6 (11.5%), 5 (9.6%) and 2 (3.8%) patients showed cancer in ipsilateral lobe, contralateral lobe and bilaterally, respectively. Treatment failure was observed in the treated lobe in 8 (15.4%) patients. Median (IQR) PSA significantly (p < 0.0001) declined to nadir PSA of 2.9 (1.5-4.2) ng/ml (57.4% reduction) at 3 mo. None of patients demonstrated undetectable PSA. All patients maintained continence with insignificant worsening of IPSS (p <0.92) and IIEF-5 (p <0.07) and low toxicity. Conclusions: FC-HA appears to maintain acceptable oncologic control in mid-term follow-up with preserved genitourinary functions and low toxicity.
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