Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04821622
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 550
• Locations: 305
• Arms: 2
• Anticipated Duration (Months): 70.9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: talazoparib plus enzalutamide; Drug: Placebo plus enzalutamide	Phase 3

Detailed Description

The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.

Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:

• Talazoparib in combination with enzalutamide.

• Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide.

Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the studyParallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• Official Title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
• Actual Study Start Date: May 12, 2021
• Anticipated Primary Completion Date: Dec 11, 2024
• Anticipated Study Completion Date: Apr 10, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Talazoparib plus enzalutamide	Drug: talazoparib plus enzalutamide; experimental arm; Other Names: Combination arm
Active Comparator: Arm 2 Placebo plus enzalutamide	Drug: Placebo plus enzalutamide; Active comparator arm; Other Names: Monotherapy arm

Outcome Measures

Primary Outcome Measures

1. radiological Progression-Free Survival [randomization up to 3 years]

   time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first

Secondary Outcome Measures

1. Overall Survival [randomization up to 4 years]

   time from randomization to death from any cause

2. Objective response in measurable soft tissue disease [randomization up to 3 years]

   proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1

3. Duration of response in measurable soft tissue disease [randomization up to 3 years]

   duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1

4. Prostate Specific Antigen (PSA) response [randomization up to 3 years]

   proportion of patients with PSA response grater than or equal to 50%

5. Time to PSA progression [randomization up to 3 years]

   time from baseline to PSA progression

6. Time to initiation of antineoplastic therapy [randomization up to 3 years]

   Time from randomization to initiation of antineoplastic therapy

7. Time to first symptomatic skeletal event [randomization up to 3 years]

   time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)

8. Opiate use for prostate cancer pain [randomization up to 3 years]

   time from randomization to opiate use for prostate cancer pain

9. Incidence of adverse events [randomization up to 3 years]

   AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)

10. Pharmacokinetic assessment of talazoparib [Weeks 5, 9, 13, and 17]

    plasma concentrations of talazoparib

11. Pharmacokinetic assessment of enzalutamide and its metabolite [Weeks 5, 9, 13, and 17]

    plasma concentrations of enzalutamide and its metabolite

12. Relationship between ctDNA burden and outcome [randomization up to 3 years]

    ctDNA burden at baseline and on study

13. Patient-reported outcomes in pain symptoms - change from baseline [randomization up to 3 years]

    change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

14. Patient-reported outcomes in pain symptoms - time to deterioration [randomization up to 3 years]

    time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

15. Patient-reported outcomes in cancer specific general health status - change from baseline [randomization up to 3 years]

    change from baseline in participant-reported general health status per EQ-5D-5L

16. Patient-reported outcomes in cancer specific global health status/QoL - change from baseline [randomization up to 3 years]

    change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30

17. Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration [randomization up to 3 years]

    time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

18. Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration [randomization up to 3 years]

    time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25

19. Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline [randomization up to 3 years]

    change from baseline in PGI-S

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).

2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.

3. Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.

4. Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion

6. Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a subset thereof, and to serve as a germline control in identifying tumor mutations.

7. Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study.

8. Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary.

9. Prior treatment of mCSPC with docetaxel is not permitted.

10. Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.

11. Other prior therapy allowed for mCSPC; ≤3 months of ADT (chemical or surgical) with or without approved NHT in mCSPC (ie, abiraterone + prednisone, apalutamide, or enzalutamide), if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.

12. Participant may have received palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should have been completed at least 2 weeks prior to randomization. NOTE: Radical prostatectomy or definitive radiotherapy to the primary tumor for metastatic castration-sensitive prostate cancer with curative intent is not permitted.

13. ECOG performance status 0 or 1.

14. Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:

• ANC ≥1500/µL, platelets ≥100,000/µL, or hemoglobin ≥9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).

• Total serum bilirubin <1.5 × ULN (<3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).

• AST or ALT <2.5 × ULN (<5 × ULN if liver function abnormalities are due to hepatic metastasis).

• Albumin >2.8 g/dL.

• eGFR ≥30 mL/min/1.73 m2 by the MDRD equation.

1. Sexually active participants that in the opinion of the investigator are capable of ejaculating, must agree to use a condom when having sex with a partner (female or male) from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide). Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib / placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide) when having sex.

2. Must agree not to donate sperm from the first dose of study treatment to 4 months after the last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide).

3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including being able to manage electronic diaries. The PRO assessments are not required to be completed if a patient does not understand the language(s) available for a specific questionnaire and/or cannot complete the specific questionnaire independently.

4. Capable of giving signed informed consent.

5. For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.

Exclusion Criteria:

1. Other acute or chronic medical (concurrent disease, infection, including chronic stable HIV, HBV, or HCV infection, or co-morbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.

2. History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient ischemic attack within 12 months of randomization.

3. Major surgery (as defined by the investigator) within 4 weeks before randomization.

4. Known or suspected brain metastasis or active leptomeningeal disease.

5. Symptomatic or impending spinal cord compression or cauda equina syndrome.

6. Any history of MDS, AML, or prior malignancy except for the following:

• Carcinoma in situ or non-melanoma skin cancer.

• A cancer diagnosed and treated ≥3 years before randomization with no subsequent evidence of recurrence.

• American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.

1. In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.

2. Clinically significant cardiovascular disease, including any of the following:

• Myocardial infarction or symptomatic cardiac ischemia within 6 months before randomization.

• Congestive heart failure New York Heart Association class III or IV.

• History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.

• History of Mobitz II second degree or third-degree heart block unless a permanent pacemaker is in place.

• Hypotension as indicated by systolic blood pressure <86 mm Hg at screening.

• Bradycardia as indicated by a heart rate of <45 beats per minute on the screening electrocardiogram.

• Uncontrolled hypertension as indicated by systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. However, participants can be rescreened after adequate control of blood pressure is achieved.

1. Active COVID-19 infection detected by viral test or based on clinical diagnosis (as assessed by investigator). Asymptomatic participants with no active COVID-19 infection detected but positive antibody tests, indicating past infection are allowed.

2. Prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.

3. Participant received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to randomization, intended for the treatment of prostate cancer.

4. Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.

5. Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.

6. Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.

7. Current use of potent P-gp inhibitors within 7 days prior to randomization.

8. Treatment with any investigational study intervention within 4 weeks before randomization. Exception: COVID-19 vaccines authorized under an emergency use authorization (or equivalent) can be administered without a washout period.

9. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >470 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.

10. Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

11. For France only: Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, as well as adults subject to a legal protection measure (guardianship, curatorship, and safeguard of justice) covered by Articles 1121-6 to 1121-8 of the Public Health Code.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
3	Arizona Institute of Urology, PLLC	Tucson	Arizona	United States	85704
4	Arkansas Urology	Little Rock	Arkansas	United States	72211
5	Arkansas Urology Research Clinic	Sherwood	Arkansas	United States	72120
6	Beverly Hills Cancer Center	Beverly Hills	California	United States	90211
7	Adventist Health Glendale	Glendale	California	United States	91206
8	VA Long Beach Healthcare System	Long Beach	California	United States	90822
9	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
10	Washington Cancer Institute at MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
11	AdventHealth Medical Group Hematology and Oncology	Orlando	Florida	United States	32804
12	Investigational Drug Services, Advent Health Orlando	Orlando	Florida	United States	32804
13	Investigational Drug Services	Orlando	Florida	United States	32804
14	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Austell	Georgia	United States	30106
15	Wellstar Cobb Hospital	Austell	Georgia	United States	30106
16	Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica	Carrollton	Georgia	United States	30117
17	West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica	Carrollton	Georgia	United States	30117
18	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Cartersville	Georgia	United States	30121
19	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Douglasville	Georgia	United States	30134
20	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Marietta	Georgia	United States	30060
21	Comprehensive Urologic Care, SC	Lake Barrington	Illinois	United States	60010
22	Mid-Illinois Hematology & Oncology Associates, Ltd	Normal	Illinois	United States	61761
23	Henry Ford Health System	Detroit	Michigan	United States	48202
24	Revive Research Institute, Inc.	Farmington Hills	Michigan	United States	48334
25	David C. Pratt Cancer Center	Saint Louis	Missouri	United States	63141
26	New Jersey Cancer Care, P.A.	Belleville	New Jersey	United States	07109
27	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York	United States	12603
28	Providence Cancer Institute Clackamas Clinic	Clackamas	Oregon	United States	97015
29	Providence Cancer Institute Newberg Clinic	Newberg	Oregon	United States	97132
30	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
31	Providence Cancer Institute Franz Clinic	Portland	Oregon	United States	97213
32	Providence Portland Medical Center	Portland	Oregon	United States	97213
33	Providence Oncology and Hematology Care Clinic - Westside	Portland	Oregon	United States	97225
34	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
35	Keystone Urology Specialists	Lancaster	Pennsylvania	United States	17604
36	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
37	Parkway Surgery Center	Myrtle Beach	South Carolina	United States	29572
38	Bristol Regional Medical Center	Bristol	Tennessee	United States	37620
39	Ballad Health Cancer Care - Kingsport	Kingsport	Tennessee	United States	37660
40	Holston Valley Hospital and Medical Center	Kingsport	Tennessee	United States	37660
41	Indian Path Community Hospital	Kingsport	Tennessee	United States	37660
42	Urology Clinics of North Texas	Dallas	Texas	United States	75231
43	Kelsey Research Foundation	Houston	Texas	United States	77005
44	Oncology Consultants, P.A.	Houston	Texas	United States	77008
45	oncology Consultants, P.A.	Houston	Texas	United States	77024
46	Kelsey-Seybold Clinic	Houston	Texas	United States	77025
47	Houston Metro Urology	Houston	Texas	United States	77027
48	Oncology Consultants P.A.	Houston	Texas	United States	77030
49	Urology San Antonio	San Antonio	Texas	United States	78229
50	Texas Oncology-Deke Slayton Cancer Center	Webster	Texas	United States	77598
51	Huntsman Cancer Institute - University of Utah	Salt Lake City	Utah	United States	84112
52	COIBA	Berazategui	Buenos Aires	Argentina	B1884BBF
53	Centro de Investigacion Pergamino SA - Clinica Pergamino SA	Pergamino	Buenos Aires	Argentina	B2700CPM
54	Centro de Investigaciones Clínicas - Clínica Viedma	Viedma	RÍO Negro	Argentina	R8500ACE
55	Centro Medico San Roque	San Miguel de Tucuman	Tucuman	Argentina	T4000IAK
56	Centro Oncologico Korben	Caba		Argentina	C1426AGE
57	Instituto Médico Especializado Alexander Fleming	Caba		Argentina	C1426ANZ
58	Centro Medico Privado CEMAIC	Córdoba		Argentina	X5008HHW
59	Chris O'Brien Lifehouse	Camperdown	New South Wales	Australia	2050
60	Southern Medical Day Care Centre	Wollongong	New South Wales	Australia	2500
61	Gallipoli Medical Research Foundation, Greenslopes Private Hospital	Brisbane	Queensland	Australia	4120
62	Gold Coast University Hospital	Southport	Queensland	Australia	4215
63	The Queen Elizabeth Hospital	Woodville South	South Australia	Australia	5011
64	Epworth Freemasons-Epworth HealthCare	East Melbourne	Victoria	Australia	3002
65	Cabrini Hospital	Malvern	Victoria	Australia	3144
66	Western Health, Sunshine Hospital	St Albans	Victoria	Australia	3021
67	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst		Belgium	9300
68	Institut Jules Bordet	Anderlecht		Belgium	1070
69	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200
70	AZ (Algemeen Ziekenhuis) Maria Middelares	Gent		Belgium	9000
71	AZ (Algemeen Ziekenhuis) Sint-Lucas	Gent		Belgium	9000
72	AZ (Algemeen Ziekenhuis) Groeninge	Kortrijk		Belgium	8500
73	CHU de Liege	Liege		Belgium	4000
74	ZNA Jan Palfijn	Merksem		Belgium	2170
75	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte		Bulgaria	4500
76	Complex Oncology Center - Plovdiv EOOD	Plovdiv		Bulgaria	4000
77	Independent medical-diagnostic laboratory "Medisken" EOOD	Plovdiv		Bulgaria	4000
78	University Multiprofile Hospital for Active Treatment Sveti Georgi EAD	Plovdiv		Bulgaria	4002
79	Complex Oncology Center - Shumen EOOD	Shumen		Bulgaria	9700
80	Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD	Sofia		Bulgaria	1407
81	University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD	Sofia		Bulgaria	1431
82	Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD	Sofia		Bulgaria
83	Complex Oncology Center - Stara Zagora Ltd.	Stara Zagora		Bulgaria	6003
84	MRI SMDLOD "Mediscan" Ltd	Stara Zagora		Bulgaria	6003
85	UMHAT "Prof. Dr. Stoyan Kirkovich"	Stara Zagora		Bulgaria	6003
86	Prostate Cancer Centre	Calgary	Alberta	Canada	T2V 1P9
87	Centre of Applied Urology Research, Nova Scotia Health Authority	Halifax	Nova Scotia	Canada	B3H 2Y9
88	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
89	The Ottawa Hospital Cancer Center	Ottawa	Ontario	Canada	K1H 8L6
90	University Health Network-Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
91	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec	Canada	G7H 5H6
92	Urology South Shore Research	Greenfield Park	Quebec	Canada	J4V 2H3
93	CHUM - Centre Hospitalier de l'Université de Montréal	Montreal	Quebec	Canada	H2X 0A9
94	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
95	McGill University Health Center	Montreal	Quebec	Canada	H4A 3J1
96	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
97	Peking University First Hospital	Beijing	Beijing	China	100034
98	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730030
99	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
100	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510515
101	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
102	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei	China	430022
103	Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
104	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
105	Hunan Cancer Hospital	Changsha	Hunan	China	410013
106	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013
107	Zhongda Hospital Southeast University	Nanjing	Jiangsu	China	210009
108	Nantong Tumor Hospital	Nantong	Jiangsu	China	226000
109	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215004
110	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi	China	330029
111	The First hospital of Jilin University	Changchun	Jilin	China	130021
112	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
113	Fudan University Cancer Hospital	Shanghai	Shanghai	China	200032
114	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
115	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin	China	300211
116	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310014
117	Ningbo First Hospital	Ningbo	Zhejiang	China	315010
118	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000
119	The First Affiliated Hospital Chongqing Medical University	Chongqing		China	400042
120	Fakultni nemocnice Olomouc	Olomouc		Czechia	779 00
121	Fakultni nemocnice Ostrava	Ostrava - Poruba		Czechia	708 52
122	Fakultni nemocnice Kralovske Vinohrady	Praha 10		Czechia	100 34
123	Fakultni nemocnice Motol	Praha 5		Czechia	150 06
124	Fakultni nemocnice Bulovka	Praha 8- Liben		Czechia	180 81
125	Helsinki University Hospital	Helsinki		Finland	00029
126	Docrates Cancer Center	Helsinki		Finland	00180
127	Kuopio University Hospital	Kuopio		Finland	70210
128	Oulun yliopistollinen sairaala	Oulu		Finland	90220
129	Tampere University Hospital	Tampere		Finland	33520
130	Turku University Hospital	Turku		Finland	20520
131	CHU Morvan de Brest	Brest	Bretagne	France	29200
132	Hopital Henri Mondor	Creteil	ILE DE France	France	94010
133	Clinique Belharra	Bayonne		France	64100
134	CHU Morvan de Brest	Brest		France	29200
135	Clinique Victor Hugo	Le Mans		France	72000
136	Hopital Prive le Bois	Lille		France	59000
137	Hopital Bichat - Claude Bernard	Paris cedex 18		France	75877
138	Hopital Bichat - Claude Bernard	Paris		France	75018
139	Hopital Lyon Sud	Pierre-Benite		France	69310
140	Clinique La Croix du Sud - Ramsay Sante	Quint Fonsegrives		France	31130
141	Institut Jean Godinot	Reims Cedex		France	51726
142	CHP Saint-Grégoire	Saint Gregoire		France	35760
143	Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)	Strasbourg		France	67200
144	Gustave Roussy	Villejuif Cedex		France	94805
145	Universitaetsmedizin Goettingen	Göttingen	Niedersachsen	Germany	37075
146	Urologische Gemeinschaftspraxis Wesel	Wesel	Nordrhein-westfalen	Germany	46483
147	Charite Universitaetsmedizin Berlin - Campus Mitte	Berlin		Germany	10117
148	Urologicum Duisburg	Duisburg		Germany	47169
149	Universitaetsklinikum Frankfurt	Frankfurt		Germany	60590
150	Institut fuer Diagnostische und Interventionelle Radiologie	Goettingen		Germany	37075
151	Klinik fuer Nuklearmedizin	Goettingen		Germany	37075
152	Universitaetsklinik Heidelberg	Heidelberg		Germany	69120
153	Uro-/Onkologisches Zentrum	Leipzig		Germany	04105
154	Studienpraxis Urologie	Nuertingen		Germany	72622
155	Universitaetsklinikum Tuebingen	Tuebingen		Germany	72076
156	Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet	Budapest		Hungary	1076
157	Országos Onkológiai Intézet	Budapest		Hungary	1122
158	Uzsoki Utcai Korhaz	Budapest		Hungary	1145
159	Jahn Ferenc Del-pesti Korhaz es Rendelointezet	Budapest		Hungary	1204
160	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház	Miskolc		Hungary	3526
161	Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet	Sopron		Hungary	9400
162	Indraprastha Apollo Hospital	New Delhi	Delhi	India	110076
163	Rajiv Gandhi Cancer Institute and Research Centre	New Delhi	Delhi	India	110085
164	Gujarat Hospital - Gastro and Vascular Centre	Surat	Gujarat	India	395009
165	Artemis hospital	Gurugram	Haryana	India	122001
166	Medanta- The Medicity hospital	Gurugram	Haryana	India	122001
167	Bhakti Vedanta Hospital and Research Institute	Mumbai, Thane	Maharashtra	India	401107
168	TATA Memorial Hospital	Mumbai	Maharashtra	India	400 012
169	Sahyadri Clinical Research & Development Centre	Pune	Maharashtra	India	411004
170	Sahyadri Super Speciality Hospital	Pune	Maharashtra	India	411004
171	Valentis Cancer Hospital	Meerut	Uttar Pradesh	India	250001
172	Netaji Subhas Chandra Bose Cancer Hospital	Kolkata	WEST Bengal	India	700094
173	Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi	Bologna	BO	Italy	40138
174	ASST Cremona	Cremona	CR	Italy	26100
175	Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)	Meldola	FC	Italy	47014
176	Fondazione Casa Sollievo della Sofferenza	San Giovanni Rotondo	FG	Italy	71013
177	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli	Napoli	Naples	Italy	80131
178	Centro di Riferimento Oncologico di Aviano (CRO) IRCCS	Aviano	PN	Italy	33081
179	Ospedale Santa Chiara	Trento	TN	Italy	38122
180	AOU San Luigi Gonzaga	Orbassano	TO	Italy	10043
181	Ospedale San Donato	Arezzo		Italy	52100
182	IRCCS Istituto Tumori "Giovanni Paolo II" di Bari	Bari		Italy	70124
183	ASST degli Spedali Civili de Brescia	Brescia		Italy	25123
184	Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy	37134
185	Nagoya University Hospital	Nagoya	Aichi	Japan	466-8560
186	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori	Japan	036-8563
187	Chiba cancer center	Chiba-shi	Chiba	Japan	260-8717
188	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
189	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime	Japan	791-0280
190	National Hospital Organization Kyushu Cancer Center	Fukuoka-shi	Fukuoka	Japan	811-1395
191	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Kure	Hiroshima	Japan	737-0023
192	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido	Japan	003-0804
193	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
194	Kanazawa University Hospital	Kanazawa	Ishikawa	Japan	920-8641
195	Yokohama City University Medical Center	Yokohama	Kanagawa	Japan	232-0024
196	Yokosukakyosai	Yokosuka	Kanagawa	Japan	238-8558
197	Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	5418567
198	Kindai University Hospital	Osakasayama	Osaka	Japan	589-8511
199	Osaka University Hospital	Suita	Osaka	Japan	565-0871
200	Hamamatsu University School of Medicine University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
201	National Hospital Organization Tokyo Medical Center	Meguro-Ku	Tokyo	Japan	152-8902
202	Keio University Hospital	Shinjuku-ku	Tokyo	Japan	160-8582
203	Kagoshima University Hospital	Kagoshima		Japan	890-8520
204	National Hospital Organization Kumamoto Medical Center	Kumamoto		Japan	860-0008
205	Tokushima University Hospital	Tokushima		Japan	770-8503
206	Yamagata University Hospital	Yamagata		Japan	990-9585
207	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	10408
208	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do	Korea, Republic of	58128
209	Seoul National University Bundang Hospital	Seongnam	Kyǒnggi-do	Korea, Republic of	13620
210	Samsung Medical Center	Seoul	Seoul-teukbyeolsi	Korea, Republic of	06351
211	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
212	Seoul National University Hospital	Seoul		Korea, Republic of	03080
213	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
214	Asan Medical Center	Seoul		Korea, Republic of	05505
215	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	06273
216	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
217	Oncologia Integral Satelite SA de CV	Naucalpan de Juarez	Estado DE Mexico	Mexico	53100
218	José Luis González Trujillo (Consultorio Privado)	León	Guanajuato	Mexico	37000
219	Axis Heilsa S. de R.L. de C.V.	Monterrey	Nuevo LEÓN	Mexico	64040
220	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEÓN	Mexico	64460
221	Oaxaca Site Management Organization	Oaxaca de Juarez	Oaxaca	Mexico	68000
222	Centro de Investigacion Clinica de Oaxaca	Oaxaca		Mexico	68020
223	Instituto Veracruzano en Investigación Clínica S.C.	Veracruz		Mexico	91851
224	Meander Medisch Centrum	Amersfoort	Utrecht	Netherlands	3813 TZ
225	Stichting HagaZiekenhuis	Den Haag		Netherlands	2545 AA
226	Sykehuset Innlandet Gjoevik	Gjoevik		Norway	2819
227	Moscow Research Oncology Institute n.a P.A. Gertsen (MROI n.a P.A. Gertsen)	Obninsk	Kaluga Region	Russian Federation	249036
228	MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia	Obninsk	Kaluga Region	Russian Federation	249036
229	State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"	Saransk	Republic OF Mordovia	Russian Federation	430032
230	Private Medical Institution "Euromedservice"	Pushkin	Saint-petersburg	Russian Federation	196603
231	Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")	Pyatigorsk	Stavropol Region	Russian Federation	357502
232	Evimed Llc	Chelyabinsk		Russian Federation	454048
233	SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"	Chelyabinsk		Russian Federation	454087
234	Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")	Ivanovo		Russian Federation	153040
235	Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of	Moscow		Russian Federation	117997
236	Branch of the Limited Liability Company "Hadassah Medical Ltd."	Moscow		Russian Federation	121205
237	Federal State Budgetary Institution "Central Clinical Hospital with ambulance"	Moscow		Russian Federation	121359
238	Moscow Research Oncology Institute n.a P.A. Gertsen (MROI n.a P.A. Gertsen)	Moscow		Russian Federation	125284
239	BHI of Omsk region "Clinical Oncological Dispensary"	Omsk		Russian Federation	644013
240	LLC "Medicina Severnoy Stolitsy"	Saint-Petersburg		Russian Federation	191025
241	LLC "Severo-Zapadny Medical Center"	Saint-Petersburg		Russian Federation	192007
242	Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"	Samara		Russian Federation	443011
243	SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan	Ufa		Russian Federation	450054
244	Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"	Vologda		Russian Federation	160002
245	Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"	Vologda		Russian Federation	160022
246	State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl		Russian Federation	150054
247	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica		Slovakia	975 17
248	Narodny onkologicky ustav	Bratislava		Slovakia	833 10
249	Vychodoslovensky onkologicky ustav, a.s.	Kosice		Slovakia	041 91
250	UROEXAM, spol. s r.o.	Nitra		Slovakia	949 01
251	POKO Poprad s.r.o.	Poprad		Slovakia	058 21
252	MILAB s.r.o.	Presov		Slovakia	08 001
253	Privatna urologicka ambulancia, s.r.o.	Trencin		Slovakia	911 01
254	Sandton Oncology Medical Group (Pty) Ltd	Johannesburg	Gauteng	South Africa	2196
255	Wits Clinical Research	Parktown, Johannesburg	Gauteng	South Africa	2193
256	Clinical Research Unit, University of Pretoria	Pretoria	Gauteng	South Africa	0002
257	Hospital General Universitario de Elche	Elche	Alicante	Spain	03203
258	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
259	Hospital Germans Trias i Pujol	Badalona	Barcelona [barcelona]	Spain	08916
260	Althaia, Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona	Spain	08243
261	Hospital Universitario Lucus Augusti	Lugo	Galicia	Spain	27003
262	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid, Comunidad DE	Spain	28222
263	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
264	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
265	Fundación Instituto Valenciano de Oncología	Valencia	Valenciana, Comunitat	Spain	46009
266	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
267	Hospital Clínic de Barcelona	Barcelona		Spain	08036
268	Hospital Universitario Reina Sofía	Cordoba		Spain	14004
269	Hospital Universitario Gregorio Marañón	Madrid		Spain	28009
270	MD Anderson Cancer Center	Madrid		Spain	28033
271	Hospital Clinico San Carlos	Madrid		Spain	28040
272	Hospital Universitario Virgen de la Macarena	Sevilla		Spain	41009
273	Hospital Politecnic Universitari La Fe	Valencia		Spain	46026
274	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
275	Taichung Veterans General Hospital	Taichung		Taiwan	40705
276	National Cheng Kung University Hospital	Tainan		Taiwan	704
277	National Taiwan University Hospital	Taipei		Taiwan	10002
278	Taipei Veterans General Hospital	Taipei		Taiwan	11217
279	Linkou Chang Gung Memorial Hospital	Taoyuan City		Taiwan	333
280	Adana City Training and Research Hospital	Adana		Turkey	01415
281	Ankara University Faculty of Medicine	Ankara		Turkey	06620
282	Ankara City Hospital	Ankara		Turkey	06800
283	Trakya University Medical Faculty	Edirne		Turkey	22030
284	Istanbul University, Cerrahpasa Faculty of Medicine	Istanbul		Turkey	34098
285	Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul		Turkey	34722
286	Inonu University, Faculty of Medicine	Malatya		Turkey	44280
287	MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department	Kryviy Rih	Dnipropetrovska Oblast	Ukraine	50048
288	Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"	Pliuty Village	KYIV Region	Ukraine	08720
289	Asklepion Medical Center	Khodosivka	Kyivska Oblast	Ukraine	08173
290	National Cancer Institute	Kyiv	Kyivska Oblast	Ukraine	03022
291	Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)	Dnipro		Ukraine	49005
292	Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council	Dnipro		Ukraine	49102
293	Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"	Ivano-Frankivsk		Ukraine	76008
294	Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of	Kharkiv		Ukraine	61037
295	Communal Non-Profit Enterprise "Regional Center of Oncology"	Kharkiv		Ukraine	61070
296	Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntr	Lviv		Ukraine	79031
297	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon	United Kingdom	EX2 5DW
298	Maidstone and Tunbridge Wells NHS Trust	Maidstone	Kent	United Kingdom	ME16 9QQ
299	Lancashire Teaching Hospitals NHS Foundation Trust	Preston	Lancashire	United Kingdom	PR2 9HT
300	NHS Lothian	Edinburgh	Midlothian	United Kingdom	EH4 2XU
301	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire	United Kingdom	S10 2SJ
302	NHS Greater Glasgow and Clyde	Glasgow		United Kingdom	G12 0YN
303	The Royal Marsden NHS Foundation Trust	London		United Kingdom	SW3 6JJ
304	Imperial College Healthcare NHS Trust	London		United Kingdom	W6 8RF
305	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Pfizer
• Astellas Pharma Inc

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04821622
• Other Study ID Numbers: C3441052; TALAPRO-3; 2021-000248-23
• First Posted: Mar 29, 2021
• Last Update Posted: Aug 19, 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 Pfizer: DDR; prostate cancer; castration-sensitive; PARP-inhibitor; hormone-sensitive; metastatic hormone-sensitive prostate cancer; Advanced prostate cancer; Metastatic castration-sensitive prostate cancer; mCSPC; enzalutamide; metastatic prostate cancer; DNA Damage Response; DNA Damage Repair
• Additional relevant MeSH terms: Prostatic Neoplasms; Talazoparib

Study Results

No Results Posted as of Aug 19, 2022