S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01309672
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 41
• Locations: 205
• Arm: 1
• Duration (Months): 133.7
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: abiraterone acetate; Drug: Prednisone	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).

Secondary

• To assess the overall survival and objective progression-free survival of this group of patients.

• To assess PSA partial response.

• To evaluate the qualitative and quantitative toxicity of abiraterone acetate.

OUTLINE: This is a multicenter study.

Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.

After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II
• Study Start Date: Aug 9, 2011
• Actual Primary Completion Date: Nov 29, 2016
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone acetate + prednisone Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily	Drug: abiraterone acetate; 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily; Drug: Prednisone; 5 mg, oral, 5 mg twice daily

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Undetectable PSA [12 months]

   undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.

Secondary Outcome Measures

1. Number of Patients With PSA Partial Response [12 months]

   PSA reduction to < 4 ng/ml, but >0.2 ng/ml

2. Objective Progression-free Survival [3 years]

   Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.

3. Overall Survival [3 years]

4. Number of Patients With Toxicity of Abiraterone Acetate [Up to 3 years]

   Only adverse events that are possibly, probably or definitely related to study drug are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate

• Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)

• Must have at least one of the following:

• Visceral disease (liver, lung, other viscera)

• Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton

• Distant lymph node disease (e.g., above the aortic bifurcation, etc.)

• No small cell or neuroendocrine prostate cancer

• Patients must be receiving ADT (e.g., gonadotropin-releasing hormone [GNRH] antagonist, with or without antiandrogen) prior to entering this study

• Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT

• Bilateral surgical orchiectomy is also acceptable

• Suboptimal response to ADT induction as defined by the following criteria:

• Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT

• PSA of > 4 ng/mL must be observed between 6-12 months after the initiation of ADT

• Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28 days of registration

• The PSA must be obtained after any applicable antiandrogen washout period

• If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen

• Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is > 4 ng/mL by month 12, in order to be eligible

• If the PSA is rising and they are on an antiandrogen, formal antiandrogen washout must be performed (4 weeks for flutamide and 6 weeks for bicalutamide and nilutamide with no evidence of a falling PSA after washout)

• No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy

• Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic CT scan) within 28 days prior to registration

• Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to registration

• No patients with a history of brain metastases or who currently have treated or untreated brain metastases

• Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• ANC ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Hemoglobin ≥ 10 g/dL

• Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min

• Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)

• AST and ALT < 1.5 times ULN

• Potassium ≥ 3.5 mmol/L

• Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to registration

• Patients must have controlled blood pressure defined as systolic blood pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg

• Patients with a history of hypertension are eligible provided blood pressure is controlled by anti-hypertensive treatment

• Patients who have partners of child-bearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last study drug administration

• Must be able to take oral medication without crushing, dissolving, or chewing tablets

• Patients must not have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of abiraterone acetate

• No other prior malignancy is allowed except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated stage I or II cancer from which the patient is currently in complete remission

• Any other cancer from which the patient has been disease-free for 5 years

• No patients with active or symptomatic viral hepatitis or chronic liver disease

• No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

• No history of NYHA class III or IV heart failure

• Patients must have LVEF ≥ 50%

• No known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist therapy (related to previous surgery or radiation) are eligible provided they finished this therapy at least two years prior to registration

• Prior enrollment to SWOG-S0925 (either arm) is not exclusionary

• At least 6 weeks since prior and no concurrent finasteride or dutasteride

• At least 28 days since prior radiotherapy or surgery and recovered

• At least 4 weeks since prior investigational products

• At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA

• No other concurrent oral antiandrogen

• No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer

• No prior or concurrent ketoconazole for the treatment of prostate cancer

• Not requiring more than 10 mg a day of prednisone for another medical indication

• Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy, surgery, or radiotherapy during protocol treatment

• No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone, PC-SPES, or spironolactone

• No concurrent antifungal medication (e.g., fluconazole or itraconazole)

• No medications that alter cardiac conduction

• No prior Provenge (sipuleucel-T)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEA Medical Clinic - East Matthews	Jonesboro	Arkansas	United States	72401
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Highlands Oncology Group - Springdale	Rogers	Arkansas	United States	72758
4	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
5	Kaiser Permanente - Fremont	Fremont	California	United States	94538
6	Kaiser Permanente Fresno Medical Center	Fresno	California	United States	93720
7	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
8	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
9	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
10	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
11	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
12	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
13	University of California Davis Cancer Center	Sacramento	California	United States	95817
14	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
15	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
16	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
17	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
18	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
19	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
20	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
21	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
22	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
23	Tahoe Forest Cancer Center	Truckee	California	United States	96161
24	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
25	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
26	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
27	San Luis Valley Regional Medical Center	Alamosa	Colorado	United States	81101
28	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
29	Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	Colorado	United States	80909
30	Shaw Regional Cancer Center	Edwards	Colorado	United States	81632
31	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
32	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
33	Valley View Hospital Cancer Center	Glenwood Springs	Colorado	United States	81601
34	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
35	Montrose Memorial Hospital Cancer Center	Montrose	Colorado	United States	81401
36	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
37	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
38	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
39	Oncare Hawaii, Incorporated - Pali Momi	'Aiea	Hawaii	United States	96701
40	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
41	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
42	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
43	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
44	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817-3169
45	Kuakini Medical Center	Honolulu	Hawaii	United States	96817
46	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
47	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
48	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
49	Castle Medical Center	Kailua	Hawaii	United States	96734
50	Kauai Medical Clinic	Lihue	Hawaii	United States	96766
51	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
52	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
53	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho	United States	83619
54	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
55	Mountain States Tumor Institute - Meridian	Meridian	Idaho	United States	83642
56	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho	United States	83686
57	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho	United States	83301
58	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
59	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
60	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
61	Mid-Illinois Hematology-Oncology Associates at Community Cancer Center	Normal	Illinois	United States	61761
62	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
63	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
64	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
65	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
66	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
67	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas	United States	67530
68	Hays Medical Center	Hays	Kansas	United States	67601
69	Hutchinson Hospital Corporation	Hutchinson	Kansas	United States	67502
70	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
71	Kansas City Cancer Centers - West	Kansas City	Kansas	United States	66112
72	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
73	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
74	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
75	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
76	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
77	Kansas City Cancer Centers - Southwest	Overland Park	Kansas	United States	66210
78	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
79	Mount Carmel Regional Cancer Center	Pittsburg	Kansas	United States	66762
80	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
81	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
82	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
83	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas	United States	66204
84	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
85	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
86	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
87	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
88	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
89	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
90	CCOP - Wichita	Wichita	Kansas	United States	67214
91	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
92	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
93	Central Baptist Hospital	Lexington	Kentucky	United States	40503-9985
94	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
95	Hematology-Oncology Clinic	Baton Rouge	Louisiana	United States	70809
96	Cancer Center of Acadiana at Lafayette General Medical Center	Lafayette	Louisiana	United States	70503
97	Highland Clinic	Shreveport	Louisiana	United States	71105
98	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
99	Caritas Holy Family Hospital	Methuen	Massachusetts	United States	01844
100	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
101	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
102	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
103	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
104	Bay Regional Medical Center	Bay City	Michigan	United States	48708
105	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
106	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
107	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
108	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
109	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
110	Hurley Medical Center	Flint	Michigan	United States	48503
111	McLaren Cancer Institute	Flint	Michigan	United States	48532
112	Singh and Arora Hematology Oncology, PC	Flint	Michigan	United States	48532
113	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
114	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
115	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
116	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
117	Foote Memorial Hospital	Jackson	Michigan	United States	49201
118	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
119	Great Lakes Cancer Institute - Lapeer Campus	Lapeer	Michigan	United States	48446
120	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
121	Clemens Regional Medical Center	Mount Clemens	Michigan	United States	48043
122	Mercy General Health Partners	Muskegon	Michigan	United States	49444
123	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
124	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
125	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
126	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
127	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
128	Munson Medical Center	Traverse City	Michigan	United States	49684
129	St. John Macomb Hospital	Warren	Michigan	United States	48093
130	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
131	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
132	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
133	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
134	Kansas City Cancer Centers - North	Kansas City	Missouri	United States	64154
135	Kansas City Cancer Centers - East	Lee's Summit	Missouri	United States	64064
136	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri	United States	63109
137	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
138	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
139	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
140	St. John's Regional Health Center	Springfield	Missouri	United States	65804
141	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
142	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
143	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
144	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
145	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
146	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
147	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
148	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
149	St. Peter's Hospital	Helena	Montana	United States	59601
150	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
151	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
152	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
153	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
154	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
155	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
156	Valley Hospital - Ridgewood	Ridgewood	New Jersey	United States	07450
157	Hematology Oncology Associates, PC	Albuquerque	New Mexico	United States	87106
158	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
159	New Mexico Cancer Care Associates	Santa Fe	New Mexico	United States	87505
160	Falck Cancer Center at Arnot Ogden Medical Center	Elmira	New York	United States	14905
161	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
162	Winthrop University Hospital	Mineola	New York	United States	11501
163	St. Luke's - Roosevelt Hospital Center - St.Luke's Division	New York	New York	United States	10025
164	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
165	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
166	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
167	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
168	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
169	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
170	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
171	CCOP - Columbus	Columbus	Ohio	United States	43215
172	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
173	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
174	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
175	Grady Memorial Hospital	Delaware	Ohio	United States	43015
176	Fairfield Medical Center	Lancaster	Ohio	United States	43130
177	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
178	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
179	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
180	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio	United States	45662
181	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
182	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
183	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
184	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
185	McLeod Regional Medical Center	Florence	South Carolina	United States	29501
186	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
187	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
188	Baylor University Medical Center - Houston	Houston	Texas	United States	77030
189	Ben Taub General Hospital	Houston	Texas	United States	77030
190	St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
191	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
192	UMC Southwest Cancer and Research Center	Lubbock	Texas	United States	79415-3364
193	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
194	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
195	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
196	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
197	St. Francis Hospital	Federal Way	Washington	United States	98003
198	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
199	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
200	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
201	Allenmore Hospital	Tacoma	Washington	United States	98405
202	CCOP - Northwest	Tacoma	Washington	United States	98405
203	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
204	St. Clare Hospital	Tacoma	Washington	United States	98499
205	Rocky Mountain Oncology	Casper	Wyoming	United States	82609

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Thomas W. Flaig, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT01309672
• Other Study ID Numbers: CDR0000696565; S1014; U10CA032102
• First Posted: Mar 7, 2011
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Southwest Oncology Group: adenocarcinoma of the prostate; hormone-resistant prostate cancer; stage IV prostate cancer; recurrent prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Abiraterone Acetate

Study Results

Participant Flow

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Period Title: Overall Study
STARTED	41
Received Protocol Treatment	40
COMPLETED	4
NOT COMPLETED	37

Baseline Characteristics

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Overall Participants	40
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	40 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.5%
Asian	2 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	10 25%
White	27 67.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	4 10%
Not Hispanic/unknown	36 90%
Testosterone (ng/dL) [Median (Full Range) ]
Median (Full Range) [ng/dL]	12.8
PSA at entry (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	23.6
Performance Status (Count of Participants)
0-1	39 97.5%
2	1 2.5%
Gleason Score (Count of Participants)
2-6	3 7.5%
7	7 17.5%
8-10	30 75%
Metastasis (Count of Participants)
Bone	37 92.5%
Lymph node	8 20%
Visceral	6 15%
Prostate RT (Count of Participants)
Yes	5 12.5%
No	35 87.5%
Prostatectomy (Count of Participants)
Yes	5 12.5%
No	35 87.5%
Antiandrogen use (Count of Participants)
Yes	35 87.5%
No	5 12.5%
PSA status at registration (Count of Participants)
Rising level	34 85%
Stable/falling level	6 15%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Undetectable PSA
Description	undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All patients who received at least 1 dose of protocol treatment

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Measure Participants	40
Count of Participants [Participants]	5 12.5%

2. Secondary Outcome

Title	Number of Patients With PSA Partial Response
Description	PSA reduction to < 4 ng/ml, but >0.2 ng/ml
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Measure Participants	40
Count of Participants [Participants]	13 32.5%

3. Secondary Outcome

Title	Objective Progression-free Survival
Description	Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Measure Participants	40
Median (95% Confidence Interval) [months]	17.5

4. Secondary Outcome

Title	Overall Survival
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Measure Participants	40
Median (95% Confidence Interval) [months]	25.8

5. Secondary Outcome

Title	Number of Patients With Toxicity of Abiraterone Acetate
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All participants receiving at least some protocol treatment

Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Measure Participants	40
Alanine aminotransferase increased	2 5%
Anorexia	1 2.5%
Aspartate aminotransferase increased	2 5%
Hyperglycemia	2 5%
Hypertension	2 5%
Hypokalemia	2 5%
INR increased	1 2.5%
Leukocytosis	1 2.5%
Lung infection	1 2.5%
Nausea	2 5%
Rectal hemorrhage	1 2.5%
Thromboembolic event	1 2.5%
Vomiting	2 5%
Weight gain	1 2.5%

Adverse Events

Time Frame	Up to 3 years
Adverse Event Reporting Description	Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Arm/Group Title	Abiraterone Acetate + Prednisone
Arm/Group Description	Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
All Cause Mortality
	Abiraterone Acetate + Prednisone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Abiraterone Acetate + Prednisone
	Affected / at Risk (%)	# Events
Total	16/40 (40%)
Blood and lymphatic system disorders
Anemia	1/40 (2.5%)
Leukocytosis	1/40 (2.5%)
Cardiac disorders
Aortic valve disease	1/40 (2.5%)
Atrial flutter	1/40 (2.5%)
Eye disorders
Retinal detachment	1/40 (2.5%)
Gastrointestinal disorders
Abdominal pain	1/40 (2.5%)
Constipation	1/40 (2.5%)
Nausea	3/40 (7.5%)
Rectal hemorrhage	1/40 (2.5%)
Small intestinal obstruction	1/40 (2.5%)
Vomiting	2/40 (5%)
General disorders
Death NOS	1/40 (2.5%)
Fatigue	1/40 (2.5%)
Fever	1/40 (2.5%)
Hepatobiliary disorders
Cholecystitis	1/40 (2.5%)
Infections and infestations
Lung infection	1/40 (2.5%)
Urinary tract infection	1/40 (2.5%)
Injury, poisoning and procedural complications
Hip fracture	1/40 (2.5%)
Injury, poison and procedural complications - Other	1/40 (2.5%)
Postoperative hemorrhage	1/40 (2.5%)
Investigations
Alanine aminotransferase increased	2/40 (5%)
Aspartate aminotransferase increased	2/40 (5%)
Blood bilirubin increased	1/40 (2.5%)
Metabolism and nutrition disorders
Anorexia	1/40 (2.5%)
Hyperglycemia	2/40 (5%)
Hyperkalemia	1/40 (2.5%)
Hypokalemia	1/40 (2.5%)
Metabolism and nutrition disorders - Other, specify	1/40 (2.5%)
Musculoskeletal and connective tissue disorders
Back pain	1/40 (2.5%)
Musculoskeletal and connective tiss disorder - Other	1/40 (2.5%)
Pain in extremity	1/40 (2.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other	1/40 (2.5%)
Nervous system disorders
Paresthesia	1/40 (2.5%)
Vascular disorders
Hypertension	1/40 (2.5%)
Thromboembolic event	2/40 (5%)
Other (Not Including Serious) Adverse Events
	Abiraterone Acetate + Prednisone
	Affected / at Risk (%)	# Events
Total	39/40 (97.5%)
Blood and lymphatic system disorders
Anemia	12/40 (30%)
Blood and lymphatic system disorders - Other	3/40 (7.5%)
Ear and labyrinth disorders
Ear and labyrinth disorders-Other	2/40 (5%)
Gastrointestinal disorders
Abdominal pain	4/40 (10%)
Constipation	9/40 (22.5%)
Diarrhea	3/40 (7.5%)
Gastroesophageal reflux disease	2/40 (5%)
Gastrointestinal disorders-Other	2/40 (5%)
Nausea	7/40 (17.5%)
Vomiting	7/40 (17.5%)
General disorders
Chills	2/40 (5%)
Edema limbs	8/40 (20%)
Fatigue	15/40 (37.5%)
Pain	6/40 (15%)
Infections and infestations
Bronchial infection	2/40 (5%)
Infections and infestations-Other	3/40 (7.5%)
Upper respiratory infection	4/40 (10%)
Injury, poisoning and procedural complications
Bruising	4/40 (10%)
Fracture	3/40 (7.5%)
Investigations
Alanine aminotransferase increased	7/40 (17.5%)
Alkaline phosphatase increased	14/40 (35%)
Aspartate aminotransferase increased	10/40 (25%)
Blood bilirubin increased	2/40 (5%)
Creatinine increased	5/40 (12.5%)
Lymphocyte count decreased	2/40 (5%)
Platelet count decreased	4/40 (10%)
Weight gain	5/40 (12.5%)
Metabolism and nutrition disorders
Anorexia	3/40 (7.5%)
Dehydration	2/40 (5%)
Hypercalcemia	3/40 (7.5%)
Hyperglycemia	14/40 (35%)
Hyperkalemia	2/40 (5%)
Hypernatremia	5/40 (12.5%)
Hypoalbuminemia	5/40 (12.5%)
Hypocalcemia	5/40 (12.5%)
Hypoglycemia	2/40 (5%)
Hypokalemia	7/40 (17.5%)
Hyponatremia	5/40 (12.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/40 (10%)
Back pain	10/40 (25%)
Bone pain	7/40 (17.5%)
Chest wall pain	2/40 (5%)
Flank pain	2/40 (5%)
Generalized muscle weakness	3/40 (7.5%)
Musculoskeletal and connective tiss disorder - Other	4/40 (10%)
Myalgia	4/40 (10%)
Pain in extremity	6/40 (15%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other	2/40 (5%)
Nervous system disorders
Dizziness	5/40 (12.5%)
Headache	4/40 (10%)
Nervous system disorders-Other	2/40 (5%)
Psychiatric disorders
Insomnia	6/40 (15%)
Renal and urinary disorders
Urinary frequency	3/40 (7.5%)
Reproductive system and breast disorders
Pelvic pain	4/40 (10%)
Respiratory, thoracic and mediastinal disorders
Cough	6/40 (15%)
Dyspnea	4/40 (10%)
Epistaxis	2/40 (5%)
Resp, thoracic and mediastinal disorders - Other	2/40 (5%)
Skin and subcutaneous tissue disorders
Rash acneiform	3/40 (7.5%)
Skin and subcutaneous tissue disorders - Other	3/40 (7.5%)
Surgical and medical procedures
Surgical and medical procedures-Other	2/40 (5%)
Vascular disorders
Hot flashes	11/40 (27.5%)
Hypertension	15/40 (37.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.