Hypothesis / aims of study
Increased rates of post-operative events such as infection, bleeding, and incontinence associated with invasive techniques in patients previously treated for prostate cancer may influence BPH-associated LUTS treatment. In this analysis, we examine outcomes in patients with a prostate cancer diagnosis who were then treated with the minimally invasive PUL using the UroLift System.
Study design, materials and methods
The Real-World Retrospective (RWR) database includes 3226 patients who underwent PUL after market clearance at 22 international sites. Patients were stratified according to those with a diagnosis of prostate cancer (n=138), those with prostate cancer who received any form of treatment (n=90), and those treated specifically with radiation (n=74). These groups were compared through 36 months post-PUL with patients without a cancer diagnosis (n=2174).
Results
5.2 years passed on average between prostate cancer diagnosis and PUL procedure. Compared to non-cancer patients, cancer patients were older (74 y.o. vs. 69 y.o.) and had significantly higher baseline PSA levels (4.0 vs. 2.3). All studied cohorts demonstrated similar improvements in IPSS, Qmax, QoL and PVR through 24 months post-PUL. Excluding standard of care catheterization, post-procedural catheter-free rates were similar between treated cancer, radiation-treated cancer, and non-cancer groups. Within 1 year of treatment, incontinence rates were 2.6% in the non-cancer group and 7.8% in the treated cancer group; 2 of 3 had ongoing urge incontinence at last contact and the remaining 4 resolved in 64 days on average. Most AEs occurred within 3 months after the procedure; no differences in rates of UTI, stricture, or hematuria were found between groups. Retreatment rates were 8.08 for all subjects, 7.29 for cancer patients, 6.66 for prostate cancer patients treated with radiation, and 8.23 for non-cancer patients per 100 patient years.
Interpretation of results
This analysis assessed outcomes of patients with prostate cancer who had a PUL procedure. All prostate cancer subgroups (diagnosed, treated, radiation-treated) improved similarly from baseline, with similar non-standard-of-care catheterization rates. Most adverse events were no different between those with baseline prostate cancer and those without, with the exception of increased incontinence in the treated cancer group, though most cases resolved in an average of 64 days post-PUL. In sum, real-world prostate cancer patients who underwent the PUL procedure experienced improvements and outcomes largely similar to non-cancer patients, without increased rates of most AEs or increased rate of retreatment.