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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04821622
• Other study ID #: C3441052
• Secondary ID: TALAPRO-32021-00
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 12, 2021
• Est. completion date: August 7, 2027

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 599
• Est. completion date: August 7, 2027
• Est. primary completion date: September 18, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 3.

5. 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.

6. 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.

7. 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.

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

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

10. 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.

11. 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.

12. ECOG performance status 0 or 1.

13. 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.

14. 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.

15. 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).

16. 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.

17. Capable of giving signed informed consent.

18. 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.

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

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

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

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

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

16. 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.

17. 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.

18. 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.

19. 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• talazoparib plus enzalutamide
experimental arm
• Placebo plus enzalutamide
Active comparator arm

Locations

Country	Name	City	State
Argentina	COIBA	Berazategui	Buenos Aires
Argentina	Centro Oncologico Korben	Caba
Argentina	Instituto Médico Especializado Alexander Fleming	Caba
Argentina	Centro Medico Privado CEMAIC	Córdoba
Argentina	Centro de Investigacion Pergamino SA - Clinica Pergamino SA	Pergamino	Buenos Aires
Argentina	Centro Medico San Roque	San Miguel de Tucuman	Tucuman
Argentina	Centro de Investigaciones Clínicas - Clínica Viedma	Viedma	RÍO Negro
Australia	Gallipoli Medical Research Foundation, Greenslopes Private Hospital	Brisbane	Queensland
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Epworth Freemasons-Epworth HealthCare	East Melbourne	Victoria
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Western Health, Sunshine Hospital	St Albans	Victoria
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Institut Jules Bordet	Anderlecht
Belgium	Cliniques universitaires Saint-Luc	Brussels
Belgium	AZ (Algemeen Ziekenhuis) Maria Middelares	Gent
Belgium	AZ (Algemeen Ziekenhuis) Sint-Lucas	Gent
Belgium	AZ (Algemeen Ziekenhuis) Groeninge	Kortrijk
Belgium	CHU de Liege	Liege
Belgium	ZNA Jan Palfijn	Merksem
Bulgaria	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte
Bulgaria	Complex Oncology Center - Plovdiv EOOD	Plovdiv
Bulgaria	Independent medical-diagnostic laboratory "Medisken" EOOD	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment Sveti Georgi EAD	Plovdiv
Bulgaria	Complex Oncology Center - Shumen EOOD	Shumen
Bulgaria	Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD	Sofia
Bulgaria	Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD	Sofia
Bulgaria	Complex Oncology Center - Stara Zagora Ltd.	Stara Zagora
Bulgaria	MRI SMDLOD "Mediscan" Ltd	Stara Zagora
Bulgaria	UMHAT "Prof. Dr. Stoyan Kirkovich"	Stara Zagora
Canada	Prostate Cancer Centre	Calgary	Alberta
Canada	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Centre of Applied Urology Research, Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	CHUM - Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Center	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Center	Ottawa	Ontario
Canada	University Health Network-Princess Margaret Cancer Centre	Toronto	Ontario
China	Peking University First Hospital	Beijing	Beijing
China	The First hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital Chongqing Medical University	Chongqing
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Henan Cancer Hospital	Zhengzhou	Henan
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Fakultni nemocnice Bulovka	Praha 8- Liben
Finland	Docrates Cancer Center	Helsinki
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
France	Centre Hospitalier Universitaire d'Angers	Angers Cedex 9
France	Clinique Belharra	Bayonne
France	CHU Morvan de Brest	Brest
France	CHU Morvan de Brest	Brest	Bretagne
France	Hopital Henri Mondor	Creteil	ILE DE France
France	Centre de Cancerologie de la Sarthe	Le Mans
France	Clinique Victor Hugo	Le Mans
France	Hopital Prive le Bois	Lille
France	Centre Leon Berard	LYON Cedex 08
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Bichat - Claude Bernard	Paris cedex 18
France	Hopital Lyon Sud	Pierre-Benite
France	Clinique La Croix du Sud - Ramsay Sante	Quint Fonsegrives
France	Institut Jean Godinot	Reims Cedex
France	CHP Saint-Grégoire	Saint Gregoire
France	Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)	Strasbourg
France	Institut de cancerologie de Lorraine	Vandoeuvre-Les-Nancy
France	Gustave Roussy	Villejuif Cedex
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte	Berlin
Germany	Urologicum Duisburg	Duisburg
Germany	Universitaetsklinikum Frankfurt	Frankfurt
Germany	Institut fuer Diagnostische und Interventionelle Radiologie	Goettingen
Germany	Klinik fuer Nuklearmedizin	Goettingen
Germany	Universitaetsmedizin Goettingen	Göttingen	Niedersachsen
Germany	Universitaetsklinik Heidelberg	Heidelberg
Germany	Jena University Hospital	Jena
Germany	Universitätsklinikum Jena	Jena	Thüringen
Germany	Uro-/Onkologisches Zentrum	Leipzig
Germany	Studienpraxis Urologie	Nuertingen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Urologische Gemeinschaftspraxis Wesel	Wesel	Nordrhein-westfalen
Hungary	Jahn Ferenc Del-pesti Korhaz es Rendelointezet	Budapest
Hungary	Országos Onkológiai Intézet	Budapest
Hungary	Péterfy Kórház-Rendelointézet és Manninger Jeno Országos Traumatológiai Intézet	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
India	Artemis hospital	Gurugram	Haryana
India	Medanta- The Medicity hospital	Gurugram	Haryana
India	Netaji Subhas Chandra Bose Cancer Hospital	Kolkata	WEST Bengal
India	Valentis Cancer Hospital	Meerut	Uttar Pradesh
India	TATA Memorial Hospital	Mumbai	Maharashtra
India	Bhakti Vedanta Hospital and Research Institute	Mumbai, Thane	Maharashtra
India	Bhaktivedanta Hospital and Research Institute	Mumbai, Thane	Maharashtra
India	Indraprastha Apollo Hospital	New Delhi	Delhi
India	Rajiv Gandhi Cancer Institute and Research Centre	New Delhi	Delhi
India	Sahyadri Clinical Research & Development Centre	Pune	Maharashtra
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
India	Gujarat Hospital - Gastro and Vascular Centre	Surat	Gujarat
Italy	Ospedale San Donato	Arezzo
Italy	Centro di Riferimento Oncologico di Aviano (CRO) IRCCS	Aviano	PN
Italy	IRCCS Istituto Tumori "Giovanni Paolo II" di Bari	Bari
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi	Bologna	BO
Italy	ASST degli Spedali Civili de Brescia	Brescia
Italy	ASST Cremona	Cremona	CR
Italy	Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)	Meldola	FC
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli	Napoli	Naples
Italy	AOU San Luigi Gonzaga	Orbassano	TO
Italy	Fondazione Casa Sollievo della Sofferenza	San Giovanni Rotondo	FG
Italy	Ospedale Santa Chiara	Trento	TN
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Japan	Chiba Cancer Center	Chiba City	Chiba
Japan	Chiba cancer center	Chiba-shi	Chiba
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Kure	Hiroshima
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	National Hospital Organization Tokyo Medical Center	Meguro-Ku	Tokyo
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka
Japan	Tokushima University Hospital	Tokushima
Japan	Yamagata University Hospital	Yamagata
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Yokosukakyosai	Yokosuka	Kanagawa
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul
Mexico	Preparaciones Oncológicas S.C.	Leon	Guanajuato
Mexico	Axis Heilsa S. de R.L. de C.V.	Monterrey	Nuevo LEÓN
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEÓN
Mexico	Oncologia Integral Satelite SA de CV	Naucalpan de Juarez	Estado DE Mexico
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Oaxaca Site Management Organization	Oaxaca de Juarez	Oaxaca
Mexico	Instituto Veracruzano en Investigación Clínica S.C.	Veracruz
Netherlands	Meander Medisch Centrum	Amersfoort	Utrecht
Netherlands	Stichting HagaZiekenhuis	Den Haag
Norway	Sykehuset Innlandet Gjoevik	Gjoevik
Russian Federation	Evimed Llc	Chelyabinsk
Russian Federation	SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"	Chelyabinsk
Russian Federation	Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")	Ivanovo
Russian Federation	Branch of the Limited Liability Company "Hadassah Medical Ltd."	Moscow
Russian Federation	Federal State Budgetary Institution "Central Clinical Hospital with ambulance"	Moscow
Russian Federation	Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of t	Moscow
Russian Federation	MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia	Obninsk	Kaluga Region
Russian Federation	BHI of Omsk region "Clinical Oncological Dispensary"	Omsk
Russian Federation	Private Medical Institution "Euromedservice"	Pushkin	Saint-petersburg
Russian Federation	Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")	Pyatigorsk	Stavropol Region
Russian Federation	LLC "Medicina Severnoy Stolitsy"	Saint-Petersburg
Russian Federation	LLC "Severo-Zapadny Medical Center"	Saint-Petersburg
Russian Federation	Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"	Samara
Russian Federation	SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan	Ufa
Russian Federation	Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"	Vologda
Russian Federation	Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"	Vologda
Russian Federation	State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav, a.s.	Kosice
Slovakia	UROEXAM, spol. s r.o.	Nitra
Slovakia	POKO Poprad s.r.o.	Poprad
Slovakia	MILAB s.r.o.	Presov
Slovakia	Privatna urologicka ambulancia, s.r.o.	Trencin
South Africa	15 Eton Road	Johannesburg	Gauteng
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Johannesburg	Gauteng
South Africa	Sandton Oncology Medical Group (Pty) Ltd	Johannesburg	Gauteng
South Africa	WCR Office	Johannesburg	Gauteng
South Africa	Wits Clinical Research	Parktown, Johannesburg	Gauteng
South Africa	Clinical Research Unit, University of Pretoria	Pretoria	Gauteng
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona [barcelona]
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitario Lucus Augusti	Lugo	Galicia
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid, Comunidad DE
Spain	Althaia, Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Fundación Instituto Valenciano de Oncología	Valencia	Valenciana, Comunitat
Spain	Hospital Politecnic Universitari La Fe	Valencia
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan City
Turkey	Adana City Training and Research Hospital	Adana
Turkey	Ankara City Hospital	Ankara
Turkey	Ankara University Faculty of Medicine	Ankara
Turkey	Ankara Bilkent Sehir Hastanesi	Bilkent	Ankara
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Istanbul University, Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Inonu University, Faculty of Medicine	Malatya
Ukraine	Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)	Dnipro
Ukraine	Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council	Dnipro
Ukraine	Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"	Ivano-Frankivsk
Ukraine	Communal Non-Profit Enterprise "Regional Center of Oncology"	Kharkiv
Ukraine	Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of	Kharkiv
Ukraine	Asklepion Medical Center	Khodosivka	Kyivska Oblast
Ukraine	MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department	Kryviy Rih	Dnipropetrovska Oblast
Ukraine	National Cancer Institute	Kyiv	Kyivska Oblast
Ukraine	Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre	Lviv
Ukraine	Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"	Pliuty Village	KYIV Region
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	NHS Lothian	Edinburgh	Midlothian
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	Maidstone and Tunbridge Wells NHS Trust	Maidstone	Kent
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston	Lancashire
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire
United States	Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital	Austell	Georgia
United States	Wellstar Cobb Hospital	Austell	Georgia
United States	New Jersey Cancer Care, P.A.	Belleville	New Jersey
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Bristol Regional Medical Center	Bristol	Tennessee
United States	Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica	Carrollton	Georgia
United States	West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica	Carrollton	Georgia
United States	Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital	Cartersville	Georgia
United States	Providence Cancer Institute Clackamas Clinic	Clackamas	Oregon
United States	Henry Ford Health System	Detroit	Michigan
United States	Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital	Douglasville	Georgia
United States	Revive Research Institute, Inc.	Farmington Hills	Michigan
United States	Adventist Health Glendale	Glendale	California
United States	Houston Metro Urology	Houston	Texas
United States	Kelsey Research Foundation	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	Oncology Consultants P.A.	Houston	Texas
United States	Oncology Consultants, P.A.	Houston	Texas
United States	oncology Consultants, P.A.	Houston	Texas
United States	Ballad Health Cancer Care - Kingsport	Kingsport	Tennessee
United States	Holston Valley Hospital and Medical Center	Kingsport	Tennessee
United States	Indian Path Community Hospital	Kingsport	Tennessee
United States	Comprehensive Urologic Care, SC	Lake Barrington	Illinois
United States	Keystone Urology Specialists	Lancaster	Pennsylvania
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Marietta	Georgia
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Parkway Surgery Center	Myrtle Beach	South Carolina
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Providence Cancer Institute Newberg Clinic	Newberg	Oregon
United States	Mid-Illinois Hematology & Oncology Associates, Ltd	Normal	Illinois
United States	Providence Cancer Institute Willamette Falls	Oregon City	Oregon
United States	AdventHealth Medical Group Hematology and Oncology	Orlando	Florida
United States	Investigational Drug Services	Orlando	Florida
United States	Investigational Drug Services, Advent Health Orlando	Orlando	Florida
United States	Providence Cancer Institute Franz Clinic	Portland	Oregon
United States	Providence Oncology and Hematology Care Clinic - Westside	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute - University of Utah	Salt Lake City	Utah
United States	Baptist M&S Imaging (STONE OAK)	San Antonio	Texas
United States	Urology San Antonio	San Antonio	Texas
United States	Urology San Antonio, PA dba USA Clinical Trials	San Antonio	Texas
United States	Willis Knighton Advanced Urology	Shreveport	Louisiana
United States	Arizona Institute of Urology, PLLC	Tucson	Arizona
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Washington Cancer Institute at MedStar Washington Hospital Center	Washington	District of Columbia
United States	Texas Oncology-Deke Slayton Cancer Center	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiological Progression-Free Survival	time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first	randomization up to 3 years
Secondary	Overall Survival	time from randomization to death from any cause	randomization up to 4 years
Secondary	Objective response in measurable soft tissue disease	proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1	randomization up to 3 years
Secondary	Duration of response in measurable soft tissue disease	duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1	randomization up to 3 years
Secondary	Prostate Specific Antigen (PSA) response	proportion of patients with PSA response grater than or equal to 50%	randomization up to 3 years
Secondary	Time to PSA progression	time from baseline to PSA progression	randomization up to 3 years
Secondary	Time to initiation of antineoplastic therapy	Time from randomization to initiation of antineoplastic therapy	randomization up to 3 years
Secondary	Time to first symptomatic skeletal event	time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)	randomization up to 3 years
Secondary	Opiate use for prostate cancer pain	time from randomization to opiate use for prostate cancer pain	randomization up to 3 years
Secondary	Incidence of adverse events	AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)	randomization up to 3 years
Secondary	Pharmacokinetic assessment of talazoparib	plasma concentrations of talazoparib	Weeks 5, 9, 13, and 17
Secondary	Pharmacokinetic assessment of enzalutamide and its metabolite	plasma concentrations of enzalutamide and its metabolite	Weeks 5, 9, 13, and 17
Secondary	Relationship between ctDNA burden and outcome	ctDNA burden at baseline and on study	randomization up to 3 years
Secondary	Patient-reported outcomes in pain symptoms - change from baseline	change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)	randomization up to 3 years
Secondary	Patient-reported outcomes in pain symptoms - time to deterioration	time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)	randomization up to 3 years
Secondary	Patient-reported outcomes in cancer specific general health status - change from baseline	change from baseline in participant-reported general health status per EQ-5D-5L	randomization up to 3 years
Secondary	Patient-reported outcomes in cancer specific global health status/QoL - change from baseline	change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30	randomization up to 3 years
Secondary	Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration	time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30	randomization up to 3 years
Secondary	Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration	time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25	randomization up to 3 years
Secondary	Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline	change from baseline in PGI-S	randomization up to 3 years

External Links

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