A population based study of patient treatment preferences for prostate cancer: early results from the Prostate Cancer Intervention Versus Observation Trial (PIVOT) Registry
Will T. J., Brawer M. K., Netto I. C. V., Johnson C. F., Crowley A. and Weiss D. G. for the VA/NCI CSP #407 Study Group. Minneapolis, MN; Seattle, WA; Hampton, VA; Temple TX; Brooklyn NY, Peny Point MD, USA.
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.
Amsterdam 1997 05.03