LAUSR

5080 Background: Patient-reported symptoms using the PRO-CTCAE provide insights into the patient experience with care. Earlier use of AAP (an androgen biosynthesis inhibitor plus prednisone) with androgen deprivation therapy in castration sensitive disease may lead to increased symptoms. We previously reported a randomized phase 2 trial of intermittent AAP, D, or AAP+D in BCRPC (NCT01751451) and now share the PRO-CTCAE results. Methods: Men were randomized 1:1:1 to AAP, D, or AAP+D for 8 months, then entered follow up with PSA, testosterone, and safety monitoring. PRO-CTCAE was elicited from patients monthly for hot flashes (HF), fatigue, arthralgias, myalgias, anxiety, depression, sexual function, plus overall QOL. Changes from baseline to end of treatment were compared between groups. AUCs were calculated for each item as a measure of symptom severity over time. Results: 110 men were included. Compliance with PRO-CTCAE reporting from baseline to EOT was 93%. HF did not differ between AAP+D and D, but were increased relative to AAP (all p < 0.05). These differences were consistent when HF were measured as an AUC (all p < 0.01). Fatigue severity did not differ between groups however men receiving AAP reported a small worsening in activity interference from fatigue as compared to AAP+D (p < 0.05). Overall QOL scores were high and did not differ with AAP+D relative to AAP or D. Conclusions: Collection of PRO-CTCAE was feasible and did not demonstrate differences in fatigue, HF, or QOL between AAP+D and D. Comparisons of PRO-CTCAE to matched clinician-reported AEs, and changes in PRO-CTCAE with testosterone recovery during follow up are planned. Clinical trial information: NCT01751451.