IPATential150: Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03072238
• Collaborator: (none)
• Enrollment: 1,101
• Locations: 184
• Arms: 2
• Anticipated Duration (Months): 75.3
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: Ipatasertib; Drug: Abiraterone; Drug: Placebo; Drug: Prednisone/Prednisolone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer
• Actual Study Start Date: Jun 30, 2017
• Actual Primary Completion Date: Mar 16, 2020
• Anticipated Study Completion Date: Oct 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Placebo + Abiraterone Participants received Placebo plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.	Drug: Abiraterone; Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.; Drug: Placebo; Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.; Drug: Prednisone/Prednisolone; Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
Experimental: Ipatasertib + Abiraterone Participants received Ipatasertib plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.	Drug: Ipatasertib; Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.; Drug: Abiraterone; Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.; Drug: Prednisone/Prednisolone; Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.

Outcome Measures

Primary Outcome Measures

1. Investigator-Assessed Radiographic Progression-Free Survival (rPFS) per PCWG3 criteria (PTEN Loss Population) [Up to approximately 31 months]

   Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in participants with phosphatase and tensin homolog (PTEN) - loss tumors (using the Ventana PTEN immunohistochemistry (IHC) assay).

2. Investigator-Assessed Radiographic Progression-Free Survival (rPFS) per PCWG3 criteria (Intent-To-Treat (ITT) Population) [Up to approximately 31 months]

   Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in the Intent-to-Treat (ITT) population.

Secondary Outcome Measures

1. Overall Survival (OS) [Up to approximately 7 years]

   Overall Survival (OS) is defined as the time from randomization to death due to any cause.

2. Time to Pain Progression [Up to approximately 7 years]

   Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who are asymptomatic at baseline or pain worsening for those who are mildly symptomatic at baseline. Pain severity will be graded on a 10-point scale, with 0=no pain and 10=severe pain. Pain severity progression is defined as a ≥ 2-point absolute increase from baseline.

3. Time to Initiation of Cytotoxic Chemotherapy [Up to approximately 7 years]

   Time to initiation of cytotoxic chemotherapy is defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for prostate cancer.

4. Time to Function Deterioration [Up to approximately 7 years]

   Time to function deterioration was defined as the time from the date of randomisation to the date of 10-point or more decrease on either the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) PF (Physical Functioning) or RF (Role Functioning) scale scores (range, 0-100) held for two consecutive assessments, or a 10 point or more score decrease followed by death (any cause) within 28 days, whichever occurs first.

5. Time to Prostate-Specific Antigen (PSA) Progression [Up to approximately 7 years]

   Time to PSA progression is defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression is defined as a PSA increase that is ≥ 25% and ≥ 2 ng/mL above the baseline or the nadir, which is confirmed by a second value ≥ 3 weeks later.

6. Time to First Opioid Use [Up to approximately 7 years]

   Time to first opioid use is defined as the documentation of the first opioid prescription for cancer-related pain followed by the participant's record of opioid intake or availability of an Analgesic Quantification Algorithm (AQA) daily score. Participants reporting use of opioid for cancer-related pain at baseline will be excluded from the analysis.

7. Time to Symptomatic Skeletal Event (SSE) [Up to approximately 7 years]

   Time to SSE is defined as the time interval from the date of randomization to the date of an SSE.

8. Objective Response Rate (ORR) [Up to approximately 7 years]

   An objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria, in participants with measurable disease at baseline. Participants without a post-baseline tumor assessment will be considered non-responders.

9. PSA Response Rate [Up to approximately 7 years]

   PSA response rate is defined as the percentage of participants achieving a PSA decline ≥50% from baseline. Participants without a post-baseline PSA assessment will be considered non-responders.

10. Investigator-Assessed rPFS per PCWG3 criteria in Participants With PTEN-Loss Tumors by Next-Generation Sequencing (NGS) [Up to approximately 7 years]

    Investigator-assessed rPFS is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first and will be analyzed in participants with PTEN-loss tumors by NGS.

11. Duration of Response (DOR) [Up to approximately 7 years]

    Duration of Response (DOR) is defined as the time from first occurrence of a documented confirmed objective response until the time of documented disease progression as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurs first.

12. Percentage of Participants with Adverse Events (AEs) [Baseline up until 28 days after the last dose of study drug or initiation of subsequent lines of anti-cancer therapy, whichever occurs first (up to a maximum of 7 years).]

    An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.

13. Plasma Concentrations of Ipatasertib at Specified Timepoints [1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 6 Day 1)]

    Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

14. Plasma Concentrations of Abiraterone at Specified Timepoints [Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1]

    Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening

• Adequate hematologic and organ function within 28 days before the first study treatment

• Ability to comply with the study protocol, in the investigator's judgment

• Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires

• Life expectancy of at least 6 months

• Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

• For enrollment into the China extension cohort, residence in the People's Republic of China

Disease-specific Inclusion Criteria:

• Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features

• Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable

• A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not permitted to enroll)

• Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1

• Asymptomatic or mildly symptomatic form of prostate cancer

• Progressive disease before initiating study treatment

• Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28 days before randomization

Exclusion Criteria:

• Inability or unwillingness to swallow whole pills

• History of malabsorption syndrome or other condition that would interfere with enteral absorption

• Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

• Need of more than 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease (e.g., rheumatic disorder)

• Active infection requiring intravenous (IV) antibiotics within 14 days before Day 1, Cycle 1

• Immunocompromised status because of current known active infection with HIV or because of the use of immunosuppressive therapies for other conditions

• Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of the need for major surgery during study treatment

• History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), untreated coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), myocardial infarction or atrial thrombotic events within the past 6 months, severe unstable angina, New York Heart Association Class III and IV heart disease or depressed left ventricular ejection fraction (LVEF; previously documented LVEF < 50% without documentation of recovery), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome

• History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 years

• Any other diseases, cardiovascular, pulmonary, or metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participants at high risk from treatment complications.

Disease-Specific Exclusion Criteria:

• Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate

• Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g., vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-α reductase inhibitor is permitted.

• Use of opioid medications for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1

• Prior treatment with abiraterone or other known potent CYP17 inhibitors (e.g., ketoconazole, orteronel) or investigational agents that block androgen synthesis. Previous treatment with itraconazole and fluconazole is permitted.

• Prior treatment with enzalutamide or other potent androgen-receptor blockers, approved or experimental (e.g., ARN-509, ODM-201, or galeterone)

• Prior treatment with flutamide (Eulexin®), steroidal anti-androgens (e.g., cyproterone acetate, chlormadinone acetate), androgens, or estrogens treatment within 4 weeks of Cycle 1, Day 1

• Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks of Cycle 1, Day 1

• Prior treatment with 5-alpha reductase inhibitors within 4 weeks of Cycle 1, Day 1

• Prior treatment with systemic radiopharmaceuticals (e.g., radium-223 and strontium-89). Radiopharmaceuticals for the purpose of imaging are permitted. Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to Cycle 1, Day 1.

• Prior treatment with approved or experimental therapeutic agents with known inhibition of the PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors

• Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1

• Known untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsant medications or corticosteroids for symptomatic control); a CT or MRI scan of the brain will be performed at screening if required by the local health authority

• Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window

Abiraterone-Specific Exclusion Criteria:

• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg)

• History of pituitary or adrenal dysfunction

• Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy

Ipatasertib-Specific Exclusion Criteria:

• Type 1 or Type 2 diabetes mellitus requiring insulin at study entry

• History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ironwood Cancer & Research Centers	Chandler	Arizona	United States	85224
2	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85025
3	USC/Westside Cancer Ctr	Beverly Hills	California	United States	90211
4	City of Hope	Duarte	California	United States	91010
5	Kaiser Permanente San Diego - Los Angeles	Los Angeles	California	United States	90027
6	USC Norris Cancer Center	Los Angeles	California	United States	90033
7	UC Irvine Medical Center	Orange	California	United States	92868
8	Stanford University	Palo Alto	California	United States	94305
9	Pacific Hematology Oncology Associates	San Francisco	California	United States	94115
10	University of Colorado Hospital - Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
11	Yale Cancer Center	New Haven	Connecticut	United States	06520
12	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
13	Lynn Cancer Institute/Boca Raton Regional Hospital	Boca Raton	Florida	United States	33486
14	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida	United States	33176
15	Northside Hospital	Atlanta	Georgia	United States	30342
16	Illinois Cancer Care	Peoria	Illinois	United States	61615
17	Associates in Oncology/Hematology P.C.	Rockville	Maryland	United States	20850
18	Tufts Medical Center	Boston	Massachusetts	United States	02111
19	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
20	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
21	Karmanos Cancer Institute..	Detroit	Michigan	United States	48201
22	HCA Midwest Division	Kansas City	Missouri	United States	64132
23	Urology Cancer Center & GU Research Network	Omaha	Nebraska	United States	68130
24	Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley	Las Vegas	Nevada	United States	89169
25	Hackensack Univ Medical Center; John Theurer Cancer Ctr	Hackensack	New Jersey	United States	07601
26	Cleveland Clinic	Cleveland	Ohio	United States	44106
27	Northwest Cancer Specialists, P.C.	Tigard	Oregon	United States	97223
28	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
29	Allegheny Cancer Center	Pittsburgh	Pennsylvania	United States	15212
30	Rhode Island Hospital	Providence	Rhode Island	United States	02903
31	Charleston Oncology, P .A	Charleston	South Carolina	United States	29414
32	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
33	Texas Oncology - Memorial City	Houston	Texas	United States	77024
34	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
35	Macquarie University Hospital	Macquarie Park	New South Wales	Australia	2109
36	Adelaide Cancer Centre	Kurralta Park	South Australia	Australia	5037
37	Monash Medical Centre; Oncology	Clayton	Victoria	Australia	3168
38	Peter Maccallum Cancer Centre	Melbourne	Victoria	Australia	3000
39	Eastern Health; GU - Oncology	Melbourne	Victoria	Australia	3128
40	LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie	Graz		Austria	8036
41	Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie	Linz		Austria	4020
42	Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU	Salzburg		Austria	5020
43	UZ Gent	Gent		Belgium	9000
44	AZ Groeninge	Kortrijk		Belgium	8500
45	CHU Sart-Tilman	Liège		Belgium	4000
46	Hospital Luxemburgo; Oncologia	Belo Horizonte	MG	Brazil	31190-131
47	Liga Norte Riograndense Contra O Câncer	Natal	RN	Brazil	59040150
48	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS	Brazil	91350-200
49	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP	Brazil	01246-000
50	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
51	Hamilton Health Sciences - Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
52	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario	Canada	L1G 2B9
53	Sunnybrook Research Institute	Toronto	Ontario	Canada	M4N 3M5
54	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 1Z5
55	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
56	Hopital Sacre-Coeur Research Centre	Montreal	Quebec	Canada	H4J 1C5
57	CHU de Québec - Université Laval - Hôtel-Dieu de Québec	Quebec		Canada	G1J 1Z4
58	Beijing Friendship Hospital Affiliated of Capital University of Medical Science	Beijing Shi		China	100050
59	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City		China	210008
60	Jiangsu Cancer Hospital	Nanjing City		China	211100
61	Fudan University Shanghai Cancer Center	Shanghai City		China	200120
62	Zhongshan Hospital Fudan University	Shanghai		China	200032
63	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an		China	710061
64	Clinica CIMCA	San José		Costa Rica	10103
65	ICIMED Instituto de Investigación en Ciencias Médicas	San José		Costa Rica	10108
66	Aarhus Universitetshospital, Urologisk Afd. K	Aarhus N		Denmark	8200
67	Odense Universitetshospital, Onkologisk Afdeling R	Odense C		Denmark	5000
68	ICO Paul Papin; Oncologie Medicale.	Angers		France	49055
69	Centre Francois Baclesse; Oncologie	Caen		France	14076
70	Centre Jean Perrin	Clermont Ferrand		France	63011
71	CHD Vendée	La Roche Sur Yon		France	85025
72	Hopital Claude Huriez; Urologie	Lille		France	59000
73	Institut régional du Cancer Montpellier	Montpellier		France	34298
74	Centre Antoine Lacassagne	Nice		France	06189
75	Institut de cancerologie du Gard	Nimes		France	30029
76	Institut Mutualiste Montsouris; Oncologie	Paris		France	75674
77	CHU Poitiers	Poitiers		France	86021
78	Hopital d'Instruction des Armees de Begin	Saint-Mande		France	94160
79	Hopital Foch; Oncologie	Suresnes		France	92151
80	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif		France	94805
81	Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine	Athens		Greece	115 28
82	IASO General Hospital of Athens	Athens		Greece	155 62
83	University Hospital of Patras Medical Oncology	Patras		Greece	265 04
84	Papageorgiou General Hospital; Medical Oncology	Thessaloniki		Greece	564 29
85	Semmelwies University of Medicine; Urology Dept.	Budapest		Hungary	1082
86	Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály	Budapest		Hungary	1122
87	Uzsoki Utcai Korhaz	Budapest		Hungary	1145
88	Debreceni Egyetem Klinikai Kozpont ; Department of Oncology	Debrecen		Hungary	4032
89	B-A-Z County Hospital	Miskolc		Hungary	3526
90	Cork University Hospital	Cork		Ireland
91	Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit	Dublin		Ireland	24
92	Mater Misericordiae Uni Hospital; Oncology	Dublin		Ireland	7
93	Mater Private Hospital	Dublin		Ireland	7
94	Rambam Health Care Campus; Oncology	Haifa		Israel	3109601
95	Meir Medical Center; Oncology	Kfar-Saba		Israel	4428164
96	Belinson Medical Center, Division of Oncology	Petach Tikva		Israel	4941492
97	Chaim Sheba medical center, Oncology division	Ramat Gan		Israel	5262000
98	ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico	Napoli	Campania	Italy	80131
99	I.R.S.T Srl IRCCS; Oncologia Medica	Meldola	Emilia-Romagna	Italy	47014
100	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna	Italy	41100
101	Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica	Roma	Lazio	Italy	00152
102	A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia	Cremona	Lombardia	Italy	26100
103	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia	Italy	20133
104	A.O. San Carlo Borromeo; U.O.C. Oncologia	Milano	Lombardia	Italy	20153
105	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia	Italy	20089
106	Ospedale Area Aretina Nord; U.O.C. Oncologia	Arezzo	Toscana	Italy	52100
107	Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1	Firenze	Toscana	Italy	50139
108	Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica	Trento	Trentino-Alto Adige	Italy	38122
109	Nagoya University Hospital	Aichi		Japan	466-8560
110	Hirosaki University Hospital	Aomori		Japan	036-8563
111	National Cancer Center East	Chiba		Japan	277-8577
112	Toho University Sakura Medical Center	Chiba		Japan	285-8741
113	Gunma University Hospital	Gunma		Japan	371-8511
114	National Hospital Organization Hokkaido Cancer Center	Hokkaido		Japan	003-0804
115	Kanazawa University Hospital	Ishikawa		Japan	920-8641
116	Yokohama City University Medical Center	Kanagawa		Japan	232-0024
117	Kitasato University Hospital	Kanagawa		Japan	252-0375
118	Kochi Medical School Hospital	Kochi		Japan	783-8505
119	Kumamoto University Hospital	Kumamoto		Japan	860-8556
120	University Hospital Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
121	Niigata University Medical & Dental Hospital	Niigata		Japan	951-8520
122	Kindai University Hospital	Osaka		Japan	589-8511
123	Toranomon Hospital	Tokyo		Japan	105-8470
124	Nippon Medical School Hospital	Tokyo		Japan	113-8603
125	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
126	Keio University Hospital	Tokyo		Japan	160-8582
127	Kyorin University Hospital	Tokyo		Japan	181-8611
128	Yamaguchi University Hospital	Yamaguchi		Japan	755-8505
129	National Cancer Center	Goyang-si		Korea, Republic of	10408
130	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13605
131	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
132	Asan Medical Center	Seoul		Korea, Republic of	05505
133	Gangnam Severance Hospital	Seoul		Korea, Republic of	06273
134	Samsung Medical Center	Seoul		Korea, Republic of	06351
135	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)	Mexico	03100
136	Centro Medico Culiacan SA de CV; Consultorio Medico 303 B	Culiacan	Sinaloa	Mexico
137	Medical Care & Research	Mérida	Yucatan	Mexico	97070
138	Consultorio de Especialidad en Urologia Privado	Durango		Mexico	34000
139	Hospital Angeles Mocel	Mexico City		Mexico	11850
140	Sykehuset Østfold Kalnes; Onkologisk seksjon	Grålum		Norway	1714
141	Akershus universitetssykehus HF	Lørenskog		Norway	1478
142	SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego	Opole		Poland	45-060
143	Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego	Warszawa		Poland	02-781
144	Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.	Warszawa		Poland	04-073
145	Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii	Wrocław		Poland	53-413
146	Woj. Wielospec. Centrum Onkologii i Traumatologii	Łódź		Poland	93-513
147	HUC; Servico de Urologia e Transplantacao Renal	Coimbra		Portugal	3000-075
148	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa		Portugal	1649-035
149	IPO do Porto; Servico de Oncologia Medica	Porto		Portugal	4200-072
150	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast	Russian Federation	143423
151	Altai Regional Oncological Center	Barnaul		Russian Federation	656049
152	Blokhin Cancer Research Center; Urological Dept	Moscow		Russian Federation	115478
153	Russian Scientific Center of Roentgenoradiology	Moscow		Russian Federation	117997
154	P.A. Herzen Oncological Inst. ; Oncology	Moscow		Russian Federation	125284
155	Privolzhsk Regional Medical Center	Nizhny Novgorod		Russian Federation	603001
156	Institut Catala d´Oncologia Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
157	Insititut Catala D'Oncologia	Hospitalet de Llobregat	Barcelona	Spain	08908
158	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona	Spain	8208
159	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba	Spain	14004
160	Hospital Universitario Son Espases; Servicio de Oncologia	Palma De Mallorca	Islas Baleares	Spain	07014
161	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra	Spain	31008
162	Hospital Clinic i Provincial; Servicio de Urología	Barcelona		Spain	08036
163	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona		Spain	08041
164	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid		Spain	28007
165	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid		Spain	28034
166	Hospital Clinico San Carlos; Servicio de Oncologia	Madrid		Spain	28040
167	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid		Spain	28041
168	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga		Spain	29010
169	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla		Spain	41013
170	KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology	Kaohsiung		Taiwan	807
171	China Medical University Hospital; Urology	Taichung		Taiwan	40447
172	Taichung Veterans General Hospital; Division of Urology	Taichung		Taiwan	407
173	Chang Gung Memorial Hospital-LinKou; Urology	Taoyuan		Taiwan	333
174	Chulalongkorn Hospital; Medical Oncology	Bangkok		Thailand	10330
175	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok		Thailand	10400
176	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok		Thailand	10700
177	Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit	Chiangmai		Thailand	50200
178	Royal Blackburn Hospital	Blackburn		United Kingdom	BB2 3HH
179	Addenbrookes Nhs Trust; Oncology Clinical Trials Unit	Cambridge		United Kingdom	CB2 0QQ
180	Leicester Royal Infirmary	Leicester		United Kingdom	LE1 5WW
181	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
182	Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology	Northwood		United Kingdom	HA6 2RN
183	Royal Marsden Hospital; Institute of Cancer Research	Sutton		United Kingdom	SM2 5PT
184	Royal Wolverhampton hospital; McHale Building	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03072238
• Other Study ID Numbers: CO39303; 2016-004429-17
• First Posted: Mar 7, 2017
• Last Update Posted: Aug 2, 2022
• Last Verified: Aug 1, 2022

• 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 Hoffmann-La Roche: Metastatic Castrate-Resistant Prostate Cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Prednisolone

Study Results

No Results Posted as of Aug 2, 2022