Introduction: While financial toxicity such as out-of-pocket cost and indirect cost facing men with prostate cancer is acknowledged, it remains understudied. We assessed the out-of-pocket burden by treatment type across low, intermediate and high risk prostate cancer groups. Methods: We used data from a multi-centered randomized controlled study among localized prostate cancer patients. Patient reported Out-of-pocket, and generic and prostate-cancer specific HRQoL outcomes were assessed at baseline, and at 3, 6, 12 and 24-month follow-up. Treatments were robotic-assisted laparoscopic radical prostatectomy (RALP), radiation therapy (RT) and active surveillance (AS). Participants were categorized into risk groups as: low risk (PSA <10 ng/ml, Gleason = 6, clinical stage T1-2a), intermediate risk (PSA 10 -20 ng/ml, Gleason 7, clinical stage T2b), and high risk (PSA > 20, Gleason =8, clinical stage T2c-3a). Out-of-pocket and indirect costs were compared by treatment type, for each risk category. Linear mixed models were applied to study the association between out-of-pocket costs, treatment and HRQoL outcomes. Results: Total of 743 localized prostate cancer patients were recruited for the study. Retention rate was > 75% during follow-up. 34% patients were low-risk, 32% were intermediate-risk and 34% were high-risk. For all risk groups, proportion of patients with out-of-pocket cost increased between baseline and 24-month, for all treatment types. Total mean of-of-pocket costs varied between RALP group and RT group at 3-month ($6782 vs. $3201), 6-month ($2873 vs. $4132), 12-month ($856 vs. $928), and at 24-month follow-up ($634 vs. $832). Linear mixed models indicated that RALP was associated with lower medication costs (OR=0.76, CI=0.52–0.91) and total out-of-pocket costs (OR=0.78, CI=0.61–0.92). Total out-of-pocket costs were inversely related to most of the generic and prostate cancer specific HRQoL items. Conclusions: This is one of the largest study that has assessed the patient reported out-of-pocket costs localized prostate cancer patients over 24 months of follow-up period. We observed that out-of-pocket of prostate cancer care are substantial and vary across risk and treatment groups. Especially, in the follow-up period, the proportion of patients with out-of-pocket cost increased significantly. Patient-centered survivorship care strategies are needed to reduce financial toxicity and improve outcomes in prostate cancer care. SOURCE OF Funding: PCORI CE-12-11-4973
