Table 2.

Serum keto-androgen levels from patients enrolled in the Targeted Androgen Pathway Suppression (TAPS) clinical trial.

	Goserelin + bicalutamide			Goserelin + dutasteride
	Before (n = 5)	After(n = 6)	p-Valuea	Before (n = 7)	After (n = 7)	p-Valuea
Analyte (ng/dL)
A	11 ± 4	11 ± 8	NS	23 ± 16	9 ± 8	<0.05
DHEA	169 ± 86	201 ± 147	NS	211 ± 100	242 ± 203	NS
Δ4-AD	52 ± 13	72 ± 50	NS	93 ± 51	123 ± 124	NS
T	349 ± 138	17 ± 16	<0.005	511 ± 186	21 ± 28	<0.0005
DHT	22 ± 13	13 ± 11	NS	44 ± 25	4 ± 4	<0.005
DHEA-G	507, 348	ND, ND, 357		507 ± 143	557 ± 200	NS
DHEA-S	127,410 ± 39,507	87,389 ± 48,433		291,494 ± 112,489	236,205 ± 61,637	NS
	Goserelin + bicalutamide + dutasteride			Goserelin + dutasteride + ketoconazole
	Before (n = 10)	After (n= 10)	p-Valuea	Before (n= 11)	After (n= 13)	p-Valuea
Analyte (ng/dL)
A	24 ± 19	11 ± 9	NS	16 ± 6	6 ± 4	<0.005
DHEA	126 ± 90	102 ± 65	NS	182 ± 79	181 ± 238	NS
Δ4-AD	76 ± 40	60 ± 27	NS	91 ± 43	72 ± 71	NS
T	508 ± 261	9 ± 3	<0.0001	634 ± 520	8 ± 7	<0.0001
DHT	49 ± 28	11 ± 6	<0.005	54 ± 45	8 ± 6	<0.0001
DHEA-G	5353 ± 12,985	2082 ± 3422	NS	2398 ± 3737	478 ± 136	<0.05
DHEA-S	97,679 ± 81,579	68,398 ± 66,636	NS	169,826 ± 161,716	49,166 ± 53,517	<0.05

All values represent the mean and standard deviation of the sample size denoted, except for the DHEA-G in the goserelin and bicalutamide arm where the individual values are listed. Patients enrolled in the clinical trial had localized advanced prostate cancer Gleason grade 3/4. Before and after 12 weeks of therapy serum samples were taken for androgen measurement. Men who would have met eligibility, but were already initiated on combined androgen blockade with an LHRH agonist and bicalutamide were accrued into arm 1 if they agreed to undergo prostatectomy within 3 months. Doses of drugs were as follows: (1) Men in arm 1 received 10.8 mg goserelin once and bicalutamide (50 mg daily). (2) Men in arm 2 received goserelin 10.8 mg once with high dose dutasteride 3.5 mg, once daily until prostatectomy. (3) Men in arm 3 received one dose of goserelin (10.8 mg), dutasteride (3.5 mg, once daily) and bicalutamide (50 mg, daily), which was initiated 7 days prior to goserelin and continued until prostatectomy. (4) Men in arm 4 received one dose of goserelin (10.8 mg), dutasteride (3.5 mg, once daily), bicalutamide (50 mg, daily) ketoconazole (200 mg, three times daily) and prednisone (5 mg, daily) until prostatectomy.

^aOne-tailed Mann-Whitney with 95% confidence intervals was used to derive p-values comparing analyte levels before and after treatment.