The Irish Programme for Stratified Prostate Cancer Therapy (iPROSPECT).

Abstract

335 Background: iPROSPECT is a prospective longitudinal translational study, funded through the Irish Cancer Society in partnership with Movember that is examining blood and tissue markers that might correlate with treatment response and survival and aid future stratification of metastatic prostate cancer (mPCa) patients with regard to optimal personalised treatment regimens. Methods: Patients with metastatic prostate cancer who are beginning or changing treatment are eligible for inclusion. Nine hospital sites supported by four research laboratories are open to recruitment. Cohort 1 (n = 15) includes patients with newly diagnosed mPCa who are beginning treatment with androgen deprivation therapy (ADT). Cohort 2 (n = 45) includes patients with CRPC who are beginning or changing treatment. All enrolled patients have blood drawn for plasma, serum and CTC analysis at baseline and thereafter every 4 months. All eligible patients with metastatic bone disease are offered an optional substudy of bone marrow biopsy performed prior to starting treatment. Any patient with visceral or nodal disease is offered a targeted CT guided biopsy. All patients are offered the PCa Research Consortium questionnaire, FACT-P and the Brief Pain inventory short form. Results: Between March and August 2015, 15 patients within cohort 1 (100%) have been enrolled and 22 patients in cohort 2 (48.8%). In cohort 1, the median age of patients was 66, median PSA at entry was 9.2 with an average Gleason score of 8. In cohort 2, the median age of patients was 68, median PSA at entry was 236.4 with an average Gleason score of 8. Eight patients underwent bone marrow biopsy, and 2 patients underwent CT guided biopsies. All patients had archival FFPE tissue collected. Questionnaires were collected from all eligible patients. Conclusions: The recruitment rate to date has indicated successful implementation of this study. Results will identify how clinical and biological patterns change over time and relate to each individual’s treatment response and progression of disease. [Table: see text]