Mp79-07 validation and Implementation of a Mobile App Decision Support System for Quality Assurance of Tumor Boards. Analyzing the Concordance Rates for Prostate Cancer at a Multidisciplinary Tumor Board of a Tertiary Referral Centre

Abstract

approved for treatment of M0 CRPC. ARN-509 as neoadjuvant treatment in organ confined disease has not been studied before. The NEAR trial is a phase II single arm study of neoadjuvant apalutamide (ARN-509) and radical prostatectomy (RP) in the treatment of D'Amico intermediate and high-risk prostate cancer (Clinicaltrials.gov identifier: NCT03124433). This study aims to report on the oncological and pathological outcomes of neoadjuvant ARN-509 before RP.METHODS: Eligibility criteria included patients between 21-75 years old diagnosed with conventional adenocarcinoma, excluding those with radio-recurrent disease, impaired liver function, and poor ECOG status (3 or below). Participants received ARN509 240mg daily for 12 weeks followed by RP within 6 weeks of the last dose of medication. Primary outcomes included tumour response defined by residual cancer burden (RCB), post-therapy morphologic characterization (groups A-C, with C being the worst response), and post-operative serum PSA levels (nadir defined as levels below 0.03ng/ml). Secondary outcomes included prevalence of significant adverse events (AE) with ARN509 and operative complications following RP. Statistical significance was defined as p<0.05.RESULTS: Of the 30 subjects enrolled, 25 participants completed the study. The median age was 68 years, and serum PSA at recruitment was 11.6ng/mL. They comprised D-Amico intermediate-risk n[12 (48%) and high-risk n[13 (52%), with ISUP grade group distributions of 1(n[1, 4%), 2(n[13, 52%), 3(n[8, 32%) and 4-5(n [3, 12%). 84% of subjects achieved post-prostatectomy nadir PSA levels, and the rest achieved nadir PSA levels of 0.03-0.05. The posttherapy morphology classifications were group A (50%), group B (10%) and group C (40%). The median reduction of serum PSA after neoadjuvant apalutamide alone was 97.3% (range 61.2 to 100.0, p<0.0001). There was one subject with an unrelated grade III AE, and no subjects with Clavien-Dindo grade III and above surgical complications.CONCLUSIONS: Results of the phase II NEAR trial show safe and reasonable oncological outcomes in patients with organ confined prostate cancer.