Introduction

Emerging evidence has suggested that local tumor control may enhance the effect of subsequent therapies in patients with metastatic prostate cancer. However, little is known about surgical safety of cytoreductive prostatectomy (CRP). In this study, we report the first interim analysis of a phase I study evaluating the safety and feasibility of CRP.

Methods

The study was approved by the IRB and activated in June, 2015. Individuals with newly diagnosed clinical metastatic prostate cancer to lymph node and bones (cT1-3N1M0 or cT1-3N0M1a-b) were recruited. Men with visceral metastasis (M1c) or ECOG PS ≥ 2 were not eligible. Following surgery, all patients received androgen deprivation therapy. The primary endpoint is the major complication rate. The secondary outcome measures are the time to PSA nadir and rate of incontinence (pad-free).

Results

A total of 21 patients from two institutions have been enrolled and undergone CRP. Of the 20 patients with complete data, the median (range) age at surgery was 62 (53-73). Overall, six (35.3%) perioperative complications were observed, including one major complication (Clavien III or higher). There were five minor complications, including deep venous thrombus (Clavien II), postoperative ileus (Clavien II), and three cases of urethral anastomotic leaks (Clavien I). In men with minimum of 6 month follow-up, 63.6% of men had PSA < 0.2 ng/ml, and 50% of men were pad free (Table 1).

Conclusions

CRP is surgically feasible in carefully selected patients. However, early incontinence rate is high. Further studies are warranted to further define long-term complications and verify the oncologic benefits of the surgery.

Funding

none