Table 3.
Characteristics of the subset of participants eligible for an end-of-study biopsy at year 6, stratified by whether or not they had the end-of-study biopsy
| Biopsied at year 7 (n = 8529) | Not biopsied (n = 5061) | p-valuea | |
|---|---|---|---|
| DEMOGRAPHICS | |||
| Age at year 6 | |||
| MEAN (SD) | 68.8 (5.4) | 69.6 (5.9) | <.0001 |
| <65 (n, %) | 2212 (25.9) | 1191 (23.5) | <.0001 |
| 65–69 (n, %) | 2733 (32.0) | 1504 (29.7) | |
| 70–75 (n, %) | 2203 (25.8) | 1292 (25.5) | |
| ≥75 (n, %) | 1381 (16.2) | 1074 (21.2) | |
| Race (n, %) | |||
| White | 7972 (93.5) | 4695 (92.8) | 0.0273 |
| Black | 258 (3.0) | 196 (3.9) | |
| Other | 299 (3.5) | 170 (3.4) | |
| Married as of randomization (n, %) | 7632 (89.5) | 4313 (85.2) | <.0001 |
| Education as of randomization (n, %) | |||
| High school diploma or less | 1517 (17.8) | 946 (18.7) | 0.3157 |
| Some college/vocational school | 2442 (28.6) | 1465 (28.9) | |
| College degree | 1441 (16.9) | 804 (15.9) | |
| Post-graduate degree | 3128 (36.7) | 1846 (36.5) | |
| Missing | 1 (0.0) | 0 (0.0) | |
| Family history of prostate cancer as of randomization (n, %) | 1387 (16.3) | 715 (14.1) | 0.0009 |
| GENERAL ADHERENCE | |||
| Adherent to study drug at year 6 (n, %) | 7181 (84.2) | 2374 (46.9) | <.0001 |
| DRE or PSA test done at year 6 (n, %) | 8397 (98.5) | 3804 (75.2) | <.0001 |
| No missed contacts before year 5 (n, %) | 5107 (59.9) | 1918 (37.9) | <.0001 |
| No missed contacts during the previous year (n, %) | 6839 (80.2) | 3231 (63.8) | <.0001 |
| Ever prompted for a biopsy (n, %) | 1661 (19.5) | 803 (15.9) | <.0001 |
| Ever refused a biopsy (n, %) | 927 (10.9) | 500 (9.9) | 0.0689 |
| Ever had a negative biopsy (n, %) | 1034 (12.1) | 431 (8.5) | <.0001 |
| COMORBIDITIES | |||
| No history of cardiovascular events (n, %) | 6084 (71.3) | 3410 (67.4) | <.0001 |
| No history of diabetes (n, %) | 7822 (91.7) | 4609 (91.1) | 0.1954 |
| Last available body mass index (BMI) | |||
| MEAN (SD) | 27.4 (4.2) | 27.4 (4.5) | 0.5811 |
| Normal (<25) (n, %) | 2156 (25.3) | 1324 (26.2) | 0.6709 |
| Overweight (25–29) (n, %) | 4155 (48.7) | 2418 (47.8) | |
| Obese (≥30) (n, %) | 2142 (25.1) | 1274 (25.2) | |
| Missing (n, %) | 76 (0.9) | 45 (0.9) | |
| Smoking status as of randomization (n, %) | |||
| Never | 2925 (34.3) | 1592 (31.5) | 0.0001 |
| Current | 576 (6.8) | 414 (8.2) | |
| Former | 5028 (59.0) | 3054 (60.3) | |
| Missing | 0 (0.0) | 1 (0.0) | |
| HEALTH-RELATED QUALITY OF LIFE AT YEAR 6 | |||
| Vitality score | |||
| MEAN (SD) | 69.5 (17.2) | 65.8 (19.9) | <.0001 |
| Average or better (n, %) | 6783 (79.5) | 2404 (47.5) | <.0001 |
| Below average (n, %) | 832 (9.8) | 516 (10.2) | |
| Missing form (n, %) | 914 (10.7) | 2141 (42.3) | |
| Physical Functioning score | |||
| MEAN (SD) | 83.3 (19.5) | 78.2 (23.9) | <.0001 |
| Average or better (n, %) | 6779 (79.5) | 2382 (47.1) | <.0001 |
| Below average (n, %) | 857 (10.0) | 545 (10.8) | |
| Missing form (n, %) | 893 (10.5) | 2134 (42.2) | |
| General Health score | |||
| MEAN (SD) | 77.2 (16.2) | 73.2 (18.8) | <.0001 |
| Average or better (n, %) | 7118 (83.5) | 2535 (50.1) | <.0001 |
| Below average (n, %) | 515 (6.0) | 394 (7.8) | |
| Missing form (n, %) | 896 (10.5) | 2132 (42.1) | |
| Mental Health score | |||
| MEAN (SD) | 84.8 (12.3) | 82.0 (14.4) | <.0001 |
| Average or better (n, %) | 6722 (78.8) | 2394 (47.3) | <.0001 |
| Below average (n, %) | 891 (10.4) | 528 (10.4) | |
| Missing form (n, %) | 916 (10.7) | 2139 (42.3) | |
| SITE CHARACTERISTICS | |||
| Ever received a recruitment and adherence grant (n, %) | 6318 (74.1) | 3049 (60.2) | <.0001 |
| Number of participants randomized at site (n, %) | |||
| ≤200 | 4581 (53.7) | 3434 (67.9) | <.0001 |
| >200 | 3948 (46.3) | 1627 (32.1) | |
| Poorly performing site (n, %) | 734 (8.6) | 835 (16.5) | <.0001 |
| Community Clinical Oncology Program (CCOP) (n, %) | 2835 (33.2) | 1570 (31.0) | 0.0076 |
a
P-values are from t-tests (comparison of means) and χ2 tests (comparison of categorical distributions)
Abbreviations: DRE = digital rectal examination; PSA = prostate specific antigen