Introduction/Objective: To determine factors associated with patient treatment preferences and randomization status in men with newly diagnosed prostate cancer (CaP).

Methods: PIVOT is a multicenter randomized trial comparing radical prostalectomy (RP) to expectant management (EM). A registry recorded tumor and demographic characteristics and treatment of all men with newly diagnosed Cap (N = 3346). Men with clinically localized CaP =< 75 years of age and PIVOT eligible were offered randomization after receiving standardized CaP information.

Results: In men with newly diagnosed CaP 27% were ineligible, 62% eligible but declined and 11% randomized. Patient's unwillingness to leave treatment decision to chance was the most common reason for randomization refusal (74%). Treatment selection of men declining randomization included: RP 37%; EM 38%; Early Hormone 8%; and Radiation 17%. Men selecting RP were younger (64 vs 68 years), less likely to have well differentiated Cap (22 vs 35%), to be Black (21 vs 31%), and had lower mean PSA values (10 vs 11 ng/ml), than those choosing EM. Among eligible men, health status was self-rated as excellent-good in > 85% and did not differ according to randomization status.

Characteristics of All Registry Patients (N=3654)

BLACK HISPANIC WHITE P VALUE

Patients (%) 25 4 70

Mean Age (SD) 69 (7) 67 (8) 69 (7) <0.001

Clin. Localized (%) 78 85 82 0.17

PSA ng/ml <0.001

Mean (SD) 40 (86) 23 (48) 23 (58)

Median 12 8 9

Histologic Grade (%) 0.79

Well differentiated 18 19 18

Mod.Differentiated 55 57 55

Poor Differentiated 21 13 19

Initial Therapy (%) 0.006

Radical Prostatectomy 21 31 25

Expectant Management 37 30 31

Hormone Therapy 21 16 17

Radiation Therapy 17 14 19

Discussion: Differences in prognostic variables associated with treatment selection confirms the need for randomized trials to determine optimal therapy for CaP. Enhancing recruitment requires addressing randomization concerns.