CHAARTED: Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

• Sponsor: ECOG-ACRIN Cancer Research Group (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00309985
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 790
• Locations: 343
• Arms: 2
• Duration (Months): 196.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Hormone-sensitive Prostate Cancer	Drug: androgen-deprivation therapy; Drug: docetaxel	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer.

Secondary

• Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone.

• Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone.

• Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone.

• Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm.

• Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone.

• Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire.

• Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival.

Tertiary

• Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer.

• Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes.

• Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs < 70), ECOG performance status (0-1 vs 2), combined androgen blockade for > 30 days (yes vs no), duration of prior adjuvant hormonal therapy (> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms.

• Arm A (Androgen-Deprivation Therapy and Docetaxel): Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

• Arm B (Androgen-Deprivation Therapy alone): Patients receive androgen-deprivation therapy (as in arm A) alone.

Quality of life is assessed at baseline and at months 3, 6, 9 and 12.

After completion of study treatment, patients are followed up periodically for up to 10 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 790 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
• Study Start Date: Jul 28, 2006
• Actual Primary Completion Date: Dec 23, 2013
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Androgen-Deprivation Therapy and Docetaxel Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: androgen-deprivation therapy; LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.; Drug: docetaxel; Given IV; Other Names: Taxotere RP 56976 NSC #628503
Active Comparator: Androgen-Deprivation Therapy alone Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.	Drug: androgen-deprivation therapy; LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.

Outcome Measures

Primary Outcome Measures

1. Overall Survival [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

   Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.

Secondary Outcome Measures

1. Time to Clinical Progression [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

   Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

2. Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

   Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

3. Proportion of Patients With PSA Complete Response (CR) at 6 Months [Assessed at 6 months]

   PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.

4. Proportion of Patients With PSA Complete Response (CR) at 12 Months [Assessed at 12 months]

   PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.

5. QOL Change From Baseline to 3 Months [Assessed at baseline and 3 months]

   The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed prostate cancer

• Metastatic disease

• On androgen-deprivation therapy for < 120 days

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

• PS 2 eligible only if decline in PS is due to metastatic prostate cancer

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ upper limit of normal (ULN)

• Alanine aminotransferase (ALT) ≤ 2.5 times ULN

• Creatinine clearance ≥ 30 mL/min

• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)

• Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)

• Fertile patients must use effective contraception

• At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization

• Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:

• Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:

• PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy

• PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy

• Therapy lasted no more than 24 months

• Last depot injection must have expired by the 24-month mark

• Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation

• Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare

• More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial

• Concurrent participation in nontherapeutic trials allowed

• Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy

Exclusion Criteria:

• Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization

• Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin

• Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair

• Peripheral neuropathy > grade 1

• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• Active cardiac disease, including the following:

• Active angina

• Symptomatic congestive heart failure

• Myocardial infarction within the past 6 months

• Prior chemotherapy in adjuvant or neoadjuvant setting

• Prior hormone therapy in the metastatic setting

• Concurrent 5-alpha reductase inhibitors

• Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Cancer Center	Anchorage	Alaska	United States	99508
2	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
3	Mayo Clinic Hospital	Phoenix	Arizona	United States	85054
4	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
5	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Fort Smith	Arkansas	United States	72903
6	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
8	Peninsula Medical Center	Burlingame	California	United States	94010
9	California Cancer Care, Incorporated - Greenbrae	Greenbrae	California	United States	94904
10	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
11	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
12	Mather Veteran Affairs Medical Center	Mather	California	United States	95655
13	Mercy Cancer Center at Mercy Medical Center	Merced	California	United States	95340
14	Memorial Medical Center	Modesto	California	United States	95355
15	Sutter Health - Western Division Cancer Research Group	Novato	California	United States	94945
16	University of California Davis Cancer Center	Sacramento	California	United States	95817
17	Saint Helena Hospital	Saint Helena	California	United States	94574
18	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
19	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
20	Tahoe Forest Cancer Center	Truckee	California	United States	96161
21	Sutter Solano Medical Center	Vallejo	California	United States	94589
22	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
23	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
24	Shaw Regional Cancer Center	Edwards	Colorado	United States	81632
25	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
26	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
27	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
28	Montrose Memorial Hospital Cancer Center	Montrose	Colorado	United States	81401
29	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
30	Yale Cancer Center	New Haven	Connecticut	United States	06520-8028
31	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
32	George Washington University Medical Center	Washington	District of Columbia	United States	20037
33	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
34	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
35	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
36	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida	United States	33458
37	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
38	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
39	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
40	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho	United States	83619
41	Idaho Urologic Institute, PA	Meridian	Idaho	United States	83642
42	Mountain States Tumor Institute - Meridian	Meridian	Idaho	United States	83642
43	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho	United States	83686
44	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho	United States	83301
45	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
46	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
47	Graham Hospital	Canton	Illinois	United States	61520
48	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
49	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
50	Memorial Hospital	Carthage	Illinois	United States	62321
51	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
52	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
53	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
54	Eureka Community Hospital	Eureka	Illinois	United States	61530
55	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
56	Evanston Hospital	Evanston	Illinois	United States	60201-1781
57	St. Francis Hospital	Evanston	Illinois	United States	60202
58	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
59	Illinois CancerCare - Cottage	Galesburg	Illinois	United States	61401
60	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
61	Kellogg Cancer Care Center	Highland Park	Illinois	United States	60035
62	Veterans Affairs Medical Center - Hines	Hines	Illinois	United States	60141
63	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
64	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
65	Provena St. Mary's Regional Cancer Center - Kankakee	Kankakee	Illinois	United States	60901
66	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
67	La Grange Memorial Hospital	La Grange	Illinois	United States	60525
68	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
69	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
70	McDonough District Hospital	Macomb	Illinois	United States	61455
71	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
72	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
73	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
74	Hematology Oncology Consultants - Naperville	Naperville	Illinois	United States	60540
75	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
76	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
77	Community Cancer Center	Normal	Illinois	United States	61761
78	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
79	Mid-Illinois Hematology-Oncology Associates at Community Cancer Center	Normal	Illinois	United States	61761
80	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
81	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
82	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
83	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
84	Proctor Hospital	Peoria	Illinois	United States	61614
85	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
86	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
87	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
88	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
89	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
90	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
91	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
92	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
93	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
94	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
95	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
96	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
97	Elkhart General Hospital	Elkhart	Indiana	United States	46515
98	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
99	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
100	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana	United States	46202
101	William N. Wishard Memorial Hospital	Indianapolis	Indiana	United States	46202
102	Howard Community Hospital	Kokomo	Indiana	United States	46904
103	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
104	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
105	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
106	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
107	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
108	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
109	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
110	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
111	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa	United States	50325
112	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
113	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
114	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
115	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
116	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
117	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
118	Veterans Affairs Medical Center - Iowa City	Iowa City	Iowa	United States	52246
119	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa	United States	52501
120	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
121	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
122	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
123	Hays Medical Center	Hays	Kansas	United States	67601
124	Hutchinson Hospital Corporation	Hutchinson	Kansas	United States	67502
125	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
126	Mount Carmel Regional Cancer Center	Pittsburg	Kansas	United States	66762
127	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
128	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
129	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
130	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
131	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
132	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
133	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
134	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201
135	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland	United States	21204
136	St. Agnes Hospital Cancer Center	Baltimore	Maryland	United States	21229
137	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
138	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
139	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
140	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts	United States	01805
141	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
142	Jordan Hospital Club Cancer Center	Plymouth	Massachusetts	United States	02360
143	Commonwealth Hematology-Oncology, PC - Quincy	Quincy	Massachusetts	United States	02169
144	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
145	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
146	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
147	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
148	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
149	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
150	Hurley Medical Center	Flint	Michigan	United States	48503
151	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
152	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
153	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
154	Foote Memorial Hospital	Jackson	Michigan	United States	49201
155	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
156	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
157	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
158	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
159	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
160	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
161	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
162	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
163	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
164	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
165	St. John Macomb Hospital	Warren	Michigan	United States	48093
166	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
167	St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
168	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
169	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
170	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
171	CCOP - Duluth	Duluth	Minnesota	United States	55805
172	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
173	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
174	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
175	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
176	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
177	Minnesota Oncology - Maplewood	Maplewood	Minnesota	United States	55109
178	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
179	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
180	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
181	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
182	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
183	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
184	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
185	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
186	Park Nicollet Cancer Center	Saint Louis Park	Minnesota	United States	55416
187	Regions Hospital Cancer Care Center	Saint Paul	Minnesota	United States	55101
188	United Hospital	Saint Paul	Minnesota	United States	55102
189	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
190	Lakeview Hospital	Stillwater	Minnesota	United States	55082
191	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
192	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
193	Minnesota Oncology - Woodbury	Woodbury	Minnesota	United States	55125
194	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
195	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
196	Central Care Cancer Center at Carrie J. Babb Cancer Center	Bolivar	Missouri	United States	65613
197	Skaggs Cancer Center at Skaggs Regional Medical Center	Branson	Missouri	United States	65616
198	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
199	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
200	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri	United States	63109
201	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
202	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
203	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
204	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
205	St. John's Regional Health Center	Springfield	Missouri	United States	65804
206	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
207	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
208	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
209	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
210	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
211	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
212	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
213	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
214	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
215	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
216	St. Peter's Hospital	Helena	Montana	United States	59601
217	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
218	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
219	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
220	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
221	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
222	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
223	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135
224	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
225	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey	United States	08822
226	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
227	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07960
228	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
229	Frederick R. and Betty M. Smith Cancer Treatment Center	Sparta	New Jersey	United States	07871
230	Overlook Hospital	Summit	New Jersey	United States	07901
231	Kings County Hospital Center	Brooklyn	New York	United States	11203
232	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
233	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
234	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
235	NYU Cancer Institute at New York University Medical Center	New York	New York	United States	10016
236	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
237	Dickstein Cancer Treatment Center at White Plains Hospital Center	White Plains	New York	United States	10601
238	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
239	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
240	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
241	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
242	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
243	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
244	MeritCare Broadway	Fargo	North Dakota	United States	58102
245	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
246	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota	United States	58122
247	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
248	Barberton Citizens Hospital	Barberton	Ohio	United States	44203
249	Cleveland Clinic Beachwood Family Health and Surgery Center	Beachwood	Ohio	United States	44122
250	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
251	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
252	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
253	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
254	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
255	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
256	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
257	CCOP - Columbus	Columbus	Ohio	United States	43215
258	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
259	Zangmeister Center	Columbus	Ohio	United States	43219
260	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
261	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
262	Grady Memorial Hospital	Delaware	Ohio	United States	43015
263	Cleveland Clinic Cancer Center	Independence	Ohio	United States	44131
264	Fairfield Medical Center	Lancaster	Ohio	United States	43130
265	St. Rita's Medical Center	Lima	Ohio	United States	45801
266	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
267	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
268	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
269	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
270	Parma Community General Hospital	Parma	Ohio	United States	44129
271	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio	United States	45662
272	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
273	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
274	Cleveland Clinic Foundation - Strongsville	Strongsville	Ohio	United States	44136
275	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
276	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
277	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
278	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
279	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
280	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
281	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
282	Adams Cancer Center	Gettysburg	Pennsylvania	United States	17325
283	Cherry Tree Cancer Center	Hanover	Pennsylvania	United States	17331
284	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
285	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
286	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
287	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
288	St. Joseph Medical Center	Reading	Pennsylvania	United States	19605
289	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
290	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
291	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
292	CCOP - Main Line Health	Wynnewood	Pennsylvania	United States	19096
293	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
294	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania	United States	17405
295	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
296	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee	United States	37208-3599
297	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
298	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
299	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
300	University Hospital - San Antonio	San Antonio	Texas	United States	78229
301	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
302	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia	United States	24501
303	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
304	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
305	Virginia Mason Medical Center	Seattle	Washington	United States	98101
306	Pacific Medical Center	Seattle	Washington	United States	98104
307	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia	United States	25304
308	Langlade Memorial Hospital	Antigo	Wisconsin	United States	54409
309	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
310	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
311	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
312	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
313	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
314	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
315	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
316	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin	United States	53038
317	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
318	Dean Medical Center - Madison	Madison	Wisconsin	United States	53717
319	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
320	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
321	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
322	Vince Lombardi Cancer Clinic - Marinette	Marinette	Wisconsin	United States	54143
323	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
324	Saint Joseph's Hospital	Marshfield	Wisconsin	United States	54449
325	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
326	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
327	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
328	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
329	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
330	St. Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
331	Vince Lombardi Cancer Clinic - Sheboygan	Sheboygan	Wisconsin	United States	53081
332	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
333	Saint Michael's Hospital Cancer Center	Stevens Point	Wisconsin	United States	54481
334	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
335	Aurora Medical Center	Summit	Wisconsin	United States	53066
336	Vince Lombardi Cancer Clinic - Two Rivers	Two Rivers	Wisconsin	United States	54241
337	Marshfield Clinic - Wausau Center	Wausau	Wisconsin	United States	54401
338	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin	United States	54401
339	Oncology Alliance, SC - Milwaukee - West	Wauwatosa	Wisconsin	United States	53226
340	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
341	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
342	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
343	Rocky Mountain Oncology	Casper	Wyoming	United States	82609

Sponsors and Collaborators

• ECOG-ACRIN Cancer Research Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Christopher Sweeney, MBBS, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Publications

None provided.

• Responsible Party: ECOG-ACRIN Cancer Research Group
• ClinicalTrials.gov Identifier: NCT00309985
• Other Study ID Numbers: E3805; E3805; U10CA180794
• First Posted: Apr 3, 2006
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by ECOG-ACRIN Cancer Research Group: metastatic hormone-sensitive prostate cancer; docetaxel
• Additional relevant MeSH terms: Prostatic Neoplasms; Hypersensitivity; Docetaxel; Androgens

Study Results

Participant Flow

Recruitment Details	This study was activated on July 28, 2006 and closed to accrual on November 21, 2012, after accrual of 790 patients.

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Period Title: Overall Study
STARTED	397	393
Toxicity Analysis	390	392
Both Baseline and 3-month FACT-P Evals	334	299
COMPLETED	335	392
NOT COMPLETED	62	1

Baseline Characteristics

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone	Total
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).	Total of all reporting groups
Overall Participants	397	393	790
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	64	63	63
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	397 100%	393 100%	790 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Description	Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	397	393
Median (95% Confidence Interval) [months]	57.6	44.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Time to Clinical Progression
Description	Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients.

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	397	393
Median (95% Confidence Interval) [months]	33.0	19.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
Description	Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients.

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	397	393
Median (95% Confidence Interval) [months]	20.2	11.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments

4. Secondary Outcome

Title	Proportion of Patients With PSA Complete Response (CR) at 6 Months
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Time Frame	Assessed at 6 months

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	397	393
Number (95% Confidence Interval) [proportion of participants]	0.320 0.1%	0.196 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Proportion of Patients With PSA Complete Response (CR) at 12 Months
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Time Frame	Assessed at 12 months

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	397	393
Number (95% Confidence Interval) [proportion of participants]	0.277 0.1%	0.168 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	QOL Change From Baseline to 3 Months
Description	The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Time Frame	Assessed at baseline and 3 months

Outcome Measure Data

Analysis Population Description

Patients with both baseline and 3-month QOL assessments are included in this analysis.

Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Measure Participants	334	299
Mean (Standard Error) [units on a scale]	-2.7 (0.9)	-1.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Wilcoxon signed rank test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy Alone
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	Wilcoxon signed rank test
	Comments

Adverse Events

Time Frame	Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description	Submission of late adverse events is required at follow-up visits up to 10 years.
Arm/Group Title	Arm A		Arm B
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.		Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
All Cause Mortality
	Arm A		Arm B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A		Arm B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	116/390 (29.7%)		12/392 (3.1%)
Blood and lymphatic system disorders
Anemia	5/390 (1.3%)		1/392 (0.3%)
Febrile neutropenia	24/390 (6.2%)		0/392 (0%)
Cardiac disorders
Left ventricular diastolic dysfunction	1/390 (0.3%)		0/392 (0%)
Left ventricular systolic dysfunction	0/390 (0%)		1/392 (0.3%)
Cardiac/heart, pain	1/390 (0.3%)		0/392 (0%)
Ear and labyrinth disorders
Tinnitus	1/390 (0.3%)		0/392 (0%)
Gastrointestinal disorders
Constipation	1/390 (0.3%)		0/392 (0%)
Diarrhea w/o prior colostomy	4/390 (1%)		0/392 (0%)
Dyspepsia	1/390 (0.3%)		0/392 (0%)
Muco/stomatitis by exam, oral cavity	2/390 (0.5%)		0/392 (0%)
Nausea	2/390 (0.5%)		0/392 (0%)
Vomiting	2/390 (0.5%)		0/392 (0%)
Abdomen, pain	1/390 (0.3%)		0/392 (0%)
General disorders
Fatigue	16/390 (4.1%)		1/392 (0.3%)
Death NOS	1/390 (0.3%)		0/392 (0%)
Edema limb	1/390 (0.3%)		0/392 (0%)
Immune system disorders
Allergic reaction	8/390 (2.1%)		0/392 (0%)
Infections and infestations
Infection w/ gr3-4 neut, heart	1/390 (0.3%)		0/392 (0%)
Infection w/ gr3-4 neut, lung	1/390 (0.3%)		0/392 (0%)
Infection w/ gr3-4 neut, skin	1/390 (0.3%)		0/392 (0%)
Infection w/ gr3-4 neut, upper airway	2/390 (0.5%)		0/392 (0%)
Infection w/ gr3-4 neut, urinary tract	1/390 (0.3%)		0/392 (0%)
Infection Gr0-2 neut, rectum	1/390 (0.3%)		0/392 (0%)
Infection Gr0-2 neut, skin	1/390 (0.3%)		0/392 (0%)
Infection w/ gr3-4 neut, blood	1/390 (0.3%)		0/392 (0%)
Infection-other	1/390 (0.3%)		0/392 (0%)
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism	0/390 (0%)		1/392 (0.3%)
Investigations
Leukocytes decreased	18/390 (4.6%)		0/392 (0%)
Lymphopenia	9/390 (2.3%)		0/392 (0%)
Neutrophils decreased	47/390 (12.1%)		0/392 (0%)
Platelets decreased	1/390 (0.3%)		0/392 (0%)
Weight gain	2/390 (0.5%)		0/392 (0%)
Alkaline phosphatase increased	2/390 (0.5%)		1/392 (0.3%)
Alanine aminotransferase increased	1/390 (0.3%)		0/392 (0%)
Creatinine increased	1/390 (0.3%)		0/392 (0%)
Metabolism and nutrition disorders
Pancreatic glucose intolerance	0/390 (0%)		1/392 (0.3%)
Anorexia	0/390 (0%)		2/392 (0.5%)
Dehydration	2/390 (0.5%)		0/392 (0%)
Hyperglycemia	3/390 (0.8%)		0/392 (0%)
Hyperkalemia	1/390 (0.3%)		1/392 (0.3%)
Hyponatremia	2/390 (0.5%)		0/392 (0%)
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness	4/390 (1%)		0/392 (0%)
Back, pain	1/390 (0.3%)		0/392 (0%)
Bone, pain	2/390 (0.5%)		1/392 (0.3%)
Joint, pain	1/390 (0.3%)		0/392 (0%)
Muscle, pain	3/390 (0.8%)		1/392 (0.3%)
Nervous system disorders
Neuropathy-motor	2/390 (0.5%)		0/392 (0%)
Neuropathy-sensory	2/390 (0.5%)		1/392 (0.3%)
Syncope	1/390 (0.3%)		0/392 (0%)
Head/headache	0/390 (0%)		1/392 (0.3%)
Reproductive system and breast disorders
Erectile impotence	1/390 (0.3%)		2/392 (0.5%)
Gynecomastia	1/390 (0.3%)		1/392 (0.3%)
Respiratory, thoracic and mediastinal disorders
Cough	1/390 (0.3%)		0/392 (0%)
Dyspnea	2/390 (0.5%)		2/392 (0.5%)
Hiccoughs	1/390 (0.3%)		0/392 (0%)
Skin and subcutaneous tissue disorders
Nail changes	1/390 (0.3%)		0/392 (0%)
Skin-other	1/390 (0.3%)		0/392 (0%)
Vascular disorders
Hypertension	1/390 (0.3%)		1/392 (0.3%)
Hot flashes	1/390 (0.3%)		1/392 (0.3%)
Thrombosis/thrombus/embolism	3/390 (0.8%)		1/392 (0.3%)
Other (Not Including Serious) Adverse Events
	Arm A		Arm B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/390 (9.7%)		1/392 (0.3%)
General disorders
Fatigue	35/390 (9%)		1/392 (0.3%)
Skin and subcutaneous tissue disorders
Alopecia	22/390 (5.6%)		0/392 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.