Introduction

Despite local therapy, a significant portion of men with high-risk PC develop progressive disease. NAB prior to RP is an approach that can potentially maximize survival outcomes in a subset of patients with localized disease. The objective of this pooled analysis was to evaluate the time to BCR in patients treated with NHT pre-RP.

Methods

This analysis included patients enrolled on three neoadjuvant trials at three institutions: Dana-Farber/Brigham and Women's Cancer Center, University of Washington, and Beth Israel Deaconess Medical Center. Study 08295 evaluated 3 months of either 1) a luteinizing hormone-releasing hormone agonist (LHRHa) + dutasteride, 2) LHRHa + dutasteride + bicalutamide, or 3) LHRHa + dutasteride + bicalutamide + ketoconazole. Study 09107 evaluated either 1) 12 weeks of abiraterone acetate (AA) and 24 weeks of a LHRHa or 2) 24 weeks of AA and 24 weeks of a LHRHa. Study 12089 evaluated 6 months of 1) enzalutamide or 2) enzalutamide + LHRHa + dutasteride. BCR is defined as a prostate specific antigen (PSA) >=0.2 ng/mL, which is confirmed, or need for salvage radiation therapy or androgen deprivation therapy. The distributions of time to BCR are estimated using the Kaplan Meier method.

Results

This analysis included 72 patients (total patient cohort 133): 57% (n=41) enrolled on 09107, 38% (n=27) enrolled on 12089, and 6% (n=4) enrolled on 08295. Overall, median follow-up was 3.4 years from RP. Prior to initiation of NAB, 12 patients (17%) had clinical T3 disease and median PSA was 8.3 ng/mL. The majority of patients had Gleason 8-10 disease (n=46, 64%). Median age at RP was 59. Eleven patients (16%) had tumor measuring <= 0.5 cm at largest diameter at RP. Four patients (6%) had a pathologic complete response (pCR). Positive margins, extraprostatic, seminal vesicle or lymph node involvement was present in 9 (13%), 39 (56%), 43 (61%), and 8 (11%) patients, respectively. Twenty-three patients (32%) experienced a BCR and the 3-year BCR free rate was 70% (57%-80%). No patient with a pCR or tumor measuring <= 0.5 cm experienced a BCR. Five patients (7%) developed metastatic disease and there was one death related to PC.

Conclusions

NAB results in cases with little or no residual tumor. Metrics of efficacy other than survival are needed; in this subset analysis of patients with available PSA data, we demonstrate that patients with minimal residual tumor and pCR have not experienced BCR.

Funding

None