Table 1.

Demographic and Clinical Characteristics of the Patients at Baseline

	PBRT Alone (n=564)		PBRT+STADT (n=578)		PLNRT+PBRT+ STADT (n=574)		Total (n=1716)
	n	%	n	%	n	%	n	%
Age(Years)
Mean	63.8		63.9		63.9		63.9
Median	64		64		64		64
Min - Max	42 – 84		39 – 80		44 – 80		39 – 84
≤49	19	3.4	15	2.6	8	1.4	42	2.4
50–59	118	20.9	137	23.7	138	24.0	393	22.9
60–69	307	54.4	299	51.7	307	53.5	913	53.2
≥70	120	21.3	127	22.0	121	21.1	368	21.4
Race
American Indian/Alaska Native	0	0.0	0	0.0	5	0.9	5	0.3
Asian	3	0.5	6	1.0	8	1.4	17	1.0
Black or African American	74	13.1	69	11.9	77	13.4	220	12.8
Native Hawaiian or Other Pacific Islander	1	0.2	4	0.7	0	0.0	5	0.3
White	464	82.3	482	83.4	474	82.6	1420	82.8
More than one race	3	0.5	0	0.0	0	0.0	3	0.2
Unknown or not reported	19	3.4	17	2.9	10	1.7	46	2.7
Ethnicity
Hispanic or Latino	21	3.7	23	4.0	30	5.2	74	4.3
Not Hispanic or Latino	511	90.6	527	91.2	517	90.1	1555	90.6
Unknown	32	5.7	28	4.8	27	4.7	87	5.1
Zubrod Performance Status
0	522	92.6	539	93.3	540	94.1	1601	93.3
1	42	7.4	39	6.7	34	5.9	115	6.7
Pathologic Seminal Vesicle Involvement
No	482	85.5	494	85.5	488	85.0	1464	85.3
Yes	82	14.5	84	14.5	86	15.0	252	14.7
Pathological Tumor Stage
T2	292	51.8	317	54.8	304	53.0	913	53.2
pT3 Extraprostatic extension NOS	13	2.3	15	2.6	18	3.1	46	2.7
pT3a Extraprostatic extension	177	31.4	162	28.0	166	28.9	505	29.4
pT3b Seminal vesicle invasion	82	14.5	84	14.5	86	15.0	252	14.7
Gleason
4	0	0.0	1	0.2	1	0.2	2	0.1
5	3	0.5	1	0.2	5	0.9	9	0.5
6	80	14.2	85	14.7	89	15.5	254	14.8
7: 3+4	226	40.1	240	41.5	221	38.5	687	40.0
7: 4+3	153	27.1	148	25.6	156	27.2	457	26.6
7: primary/secondary not indicated	9	1.6	5	0.9	3	0.5	17	1.0
8	57	10.1	60	10.4	57	9.9	174	10.1
9	36	6.4	38	6.6	42	7.3	116	6.8
Prostatectomy Margins
Positive	288	51.1	289	50.0	284	49.5	861	50.2
Negative	267	47.3	284	49.1	287	50.0	838	48.8
Unknown	9	1.6	5	0.9	3	0.5	17	1.0
Pelvic Lymphadenectomy
No	189	33.5	207	35.8	209	36.4	605	35.3
Yes	375	66.5	371	64.2	365	63.6	1111	64.7
Number of Lymph Nodes Examined*	(n=349)		(n=336)		(n=336)		(n=1021)
Mean	7.2		7.8		7.2		7.4
Median	5		6		5		6
Min - Max	0 – 34		1 – 54		1 – 32		0 – 54
Pre-RT Entry PSA (ng/ml)
Mean	0.47		0.51		0.47		0.48
Median	0.32		0.40		0.32		0.35
Min - Max	0.1 – 1.96		0.1 – 1.93		0.1 – 1.93		0.1 – 1.96
≥ 0.1 and ≤ 0.2 ng/ml	155	27.5	126	21.8	154	26.8	435	25.3
> 0.2 and ≤ 0.5 ng/ml	247	43.8	256	44.3	247	43.0	750	43.7
> 0.5 and ≤ 1.0 ng/ml	105	18.6	130	22.5	114	19.9	349	20.3
> 1.0 and < 2.0 ng/ml	57	10.1	66	11.4	59	10.3	182	10.6
Time from Surgery to Randomization
>0 and ≤6 months	47	8.6	29	5.2	26	4.6	102	6.1
>6 and ≤12 months	90	16.4	111	19.8	95	16.9	296	17.7
>12 and ≤18 months	55	10.0	61	10.9	71	12.6	187	11.2
> 18 months	356	65.0	361	64.2	371	65.9	1088	65.0
Median (years)	2.3		2.1		2.1		2.2
Min - Max	0.1 – 20.5		0.1 – 17.6		0.1 – 17.7		0.1 – 20.5
Post-operative PSA Doubling Time**	(n=156)		(n=156)		(n=159)		(n=471)
>0 and ≤6 months	34	21.8	32	20.5	32	20.1	98	20.8
>6 and ≤12 months	54	34.6	55	35.3	62	39.0	171	36.3
>12 and ≤18 months	26	16.7	33	21.2	27	17.0	86	18.3
> 18 months	42	26.9	36	23.1	38	23.9	116	24.6

^*Data are not available for all patients who underwent a lymphadenectomy and these patients were excluded from the lymph node number calculations.

^**The requirement to record PSA doubling time prior to enrollment was dropped in an amendment to the protocol. Only n=471 values were available.