INTRODUCTION AND OBJECTIVE:
We recently described a novel surgical form of focal therapy for prostate cancer (CaP) treatment -- the precision prostatectomy. Here we report on the functional and oncological outcomes of the first 88 consecutive patients.
Men who met the criteria: 1) PSA ≤15 ng/mL, 2) stage ≤cT2, 3) dominant unilateral lesion with Gleason ≤4+3 with any number or % of cores involved ipsilaterally on biopsy, 4) no primary Gleason ≥4 contralaterally, and 5) preoperative erectile function score (IIEF-5) of ≥17/25 with/without PDE-5i were included in this prospective, single-arm, IDEAL stage 2b study (Dec 2016-Jan 2020). Safety of the precision prostatectomy technique, and urinary, sexual and oncological outcomes were studied. Descriptive statistics and Kaplan-Meier analysis were used to assess 12-month urinary continence (0-1 pad), 12-month sexual potency (SHIM ≥17), and 36-month freedom from clinically-significant CaP (grade group ≥2), secondary treatment, metastatic disease and mortality.
At study-entry, the median (IQR) age, PSA and SHIM scores were 60 (54.2-65.9) years, 5.7 (4.2-7.1) ng/mL and 22 (19-24), respectively. All patients were followed for a minimum of 6 months. At 12-months, from a functional standpoint, all (100%) patients were continent (0-1 pads), with 90.9% of the patients using 0 pads (Figure 1a). The median (IQR) time to urinary continence was 1 (1-4) months. 85% of all-comers were potent at 12-months, while 90.2% of the preoperatively potent patients were potent at 12-months (Figure 1b). The median SHIM score was 21 at 12-months. The median time to sexual potency was 4 (4-12) months. From an oncological standpoint, at 36-months, 6.6% of the patients were found to have clinically-significant residual CaP on follow-up biopsies, and 9.3% had required secondary therapy (removal of the remnant tissue). All patients were alive and free of metastatic disease at the latest follow-up (Figure 1c).
Precision prostatectomy is technically safe, and offers excellent postoperative functional results. At 36-months of follow-up, the oncological outcomes and secondary treatment rates were at least at-par with the ablative forms of focal therapy. Pending long-term data from prospective studies, a risk-stratified surgical approach to CaP may avoid whole-gland therapy and preserve functional QoL in men with CaP.
Source of Funding: