Trial Condition(s):

Metastatic hormone-sensitive prostate cancer

ODM-201 in addition to standard ADT and docetaxel in metastatic castration sensitive prostate cancer (ARASENS)

Bayer Identifier:

17777

ClinicalTrials.gov Identifier:

NCT02799602

EudraCT Number:

2015-002590-38

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Inclusion Criteria

- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Metastatic disease
- Candidates for ADT and docetaxel.
- Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 
- Adequate bone marrow, liver and renal function

Exclusion Criteria

- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
- Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease–free
- Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
- Inability to swallow oral medications

Trial Summary

Enrollment Goal

1306

Trial Dates

November2016

April2023

Phase

Could I receive a placebo?

Yes

Products

Darolutamide+ADT+docetaxel (BAY1841788)

Accepts Healthy Volunteers

Where to Participate

Locations

Locations
Locations Investigative Site Roma, Italy, 00152	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Torino, Italy, 10043	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Tel Aviv, Israel, 6423906	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Zrifin, Israel, 7030000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Barcelona, Spain, 08023	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site GENT, Belgium, 9000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Barcelona, Spain, 8036	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Córdoba, Spain, 14004	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Sabadell, Spain, 08208	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Berlin, Germany, 12203	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Tübingen, Germany, 72076	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Münster, Germany, 48149	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Jena, Germany, 07747	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Padova, Italy, 35128	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Milano, Italy, 20141	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Valencia, Spain, 46009	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Nürtingen, Germany, 72622	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site London, United Kingdom, NW1 2BU	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Sofia, Bulgaria, 1303	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Chicago, United States, 60611	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Peoria, United States, 61615-7828	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Sakura, Japan, 285-8741	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Hamamatsu, Japan, 431-3192	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Bunkyo-ku, Japan, 113-8655	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Calgary, Canada, T2N 4N2	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Yonago, Japan, 683-8504	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Utsunomiya, Japan, 321-0974	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Kanazawa, Japan, 920-8641	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Chiba, Japan, 260-8717	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Nagoya, Japan, 466-8560	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Suita, Japan, 565-0871	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Mitaka, Japan, 181-8611	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Koto-ku, Japan, 135-8550	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Tsu, Japan, 514-8507	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Mikkeli, Finland, FIN-50100	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Warszawa, Poland, 02-781	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Fukuoka, Japan, 811-1395	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Ube, Japan, 755-8505	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Kashihara, Japan, 634-8522	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Miyazaki, Japan, 889-1692	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Shimotsuke, Japan, 329-0498	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Kumamoto, Japan, 860-0008	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Okayama, Japan, 700-8558	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Yokohama, Japan, 241-8515	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Mazatlán, Mexico, 82110	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Jerusalem, Israel, 9112001	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Parma, Italy, 43126	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site Asahi, Japan, 289-2511	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Locations Investigative Site BESANCON, France, 25030	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Gifu, Japan, 500-8717	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Praha 8, Czech Republic, 180 81	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Turku, Finland, 20520	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Praha 10, Czech Republic, 10034	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Glasgow, United Kingdom, G12 0YN	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Gabrovo, Bulgaria, 5300	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Sydney, Australia, 2010	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Hoofddorp, Netherlands, 2134 TM	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site AMSTERDAM, Netherlands, 1066 CX	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site DORDRECHT, Netherlands, 3318 AT	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Charleston, United States, 29414	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Englewood, United States, 07361	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Chandler, United States, 85224	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Braunschweig, Germany, 38126	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Ulm, Germany, 89075	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Barcelona, Spain, 08041	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Palma De Mallorca, Spain, 7120	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Lugo, Spain, 27003	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Cáceres, Spain, 10003	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Erlangen, Germany, 91054	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Tilburg, Netherlands, 5042 AD	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Natal, Brazil, 59040-000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Verona, Italy, 37134	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Beijing, China, 100034	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Yantai, China, 264000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Wuhan, China, 430030	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Tianjin, China, 300052	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Zhengzhou, China, 450008	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Chongqing, China, 400030	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Changchun, China, 130000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Salt Lake City, United States, 84112	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Bronx, United States, 10467-2490	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Boston, United States, 02215	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Chelyabinsk, Russia, 454087	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Novara, Italy, 28100	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site SAINT-GREGOIRE, France, 35760	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Bordeaux Cedex, France, 33076	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site St. Petersburg, Russia, 188663	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site St. Petersburg, Russia, 194017	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site NAMUR, Belgium, 5000	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Beverly Hills, United States, 90211-1850	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Jinan, China, 250012	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Charleston, United States, 29401-5799	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site BREST, France, 29200	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Albuquerque, United States, 87109	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Beijing, China, 100083	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Hangzhou, China, 310009	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Madrid, Spain, 28034	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
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Roma, Italy, 00152

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Tel Aviv, Israel, 6423906

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Zrifin, Israel, 7030000

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Barcelona, Spain, 08023

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BRUXELLES - BRUSSEL, Belgium, 1200

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GENT, Belgium, 9000

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Barcelona, Spain, 8036

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Córdoba, Spain, 14004

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Sabadell, Spain, 08208

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BRUXELLES - BRUSSEL, Belgium, 1070

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Berlin, Germany, 12203

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Tübingen, Germany, 72076

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Münster, Germany, 48149

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Jena, Germany, 07747

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Padova, Italy, 35128

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Duarte, United States, 91010

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Boca Raton, United States, 33486

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VILLEJUIF CEDEX, France, 94805

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POITIERS, France, 86021

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Saint Herblain Cedex, France, 44805

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ANGERS CEDEX, France, 49055

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Siedlce, Poland, 08-110

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Edmonton, Canada, T6G 1Z2

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Montreal, Canada, H2L 4M1

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Praha 5, Czech Republic, 150 06

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Brno, Czech Republic, 602 00

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Praha 2, Czech Republic, 120 00

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Haifa, Israel, 3109601

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Petach Tikva, Israel, 4941492

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Holon, Israel, 5822012

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Beer Sheva, Israel, 8410101

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Zefat, Israel, 1311001

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Moscow, Russia, 125284

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Omsk, Russia, 644013

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Moscow, Russia, 115478

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St. Petersburg, Russia, 197136

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Barnaul, Russia, 656045

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Novosibirsk, Russia, 630099

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New Orleans, United States, 70112

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Columbus, United States, 43214-2416

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Baltimore, United States, 21231

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Columbus, United States, 43210

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Oklahoma City, United States, 73104

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Towson, United States, 21204

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Greenville, United States, 29607

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Boston, United States, 02111

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Dallas, United States, 75231

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Tucson, United States, 85724

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PIERRE BENITE, France, 69495

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CERGY PONTOISE, France, 95303

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Varna, Bulgaria, 9010

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Vratsa, Bulgaria, 3000

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Seoul, South Korea, 06351

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Seoul, South Korea, 06273

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Seoul, South Korea, 05505

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Seoul, South Korea, 03080

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Lublin, Poland, 20-362

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Taoyuan, Taiwan, China, 33305

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Taipei, Taiwan, China, 11217

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Kurralta Park, Australia, 5037

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Helsinki, Finland, 00290

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Kuopio, Finland, 70210

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Kettering, United States, 45409-1328

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Trial Design

A randomized, double-blind, placebo controlled Phase III study of darolutamide (ODM-201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone sensitive prostate cancer

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Randomized

Blinding:

Double Blind

Assignment:

Parallel Assignment

Trial Arms:

Primary Outcome

OS from date of randomization until death from any cause
Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
Timeframe: From randomization of the first subject until death from any cause up to the time 533 OS events were reached (approximately 59 months)

Secondary Outcome

Number of participants with TEAEs
TEAEs = Treatment-emergent adverse events Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
Timeframe: From the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 JUN 2023 (approximately 79 months)

Time to castration–resistant prostate cancer (CRPC)
Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Timeframe: From randomization of the first subject to the first occurrence of an CRPC event up to approximately 59 months

Time to pain progression
Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Timeframe: From randomization of the first subject to the first occurrence of an pain progression event up to approximately 59 months

Symptomatic skeletal event free survival (SSE–FS)
Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Timeframe: From randomization of the first subject to the first occurrence of an SSE event or death from any cause, whichever occurred first up to approximately 59 months

Time to first symptomatic skeletal event (SSE)
Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Timeframe: From randomization of the first subject to the first occurrence of an SSE event up to approximately 59 months

Time to initiation of subsequent antineoplastic therapy
Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Timeframe: From randomization of the first subject to the initiation of first subsequent systemic antineoplastic therapy up to approximately 59 months

Time to worsening of disease–related physical symptoms
Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Timeframe: From randomization of the first subject to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to approximately 59 months

Time to initiation of opioid use for ≥7 consecutive days
Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Timeframe: From randomization of the first subject to the first opioid use for ≥7 consecutive days up to approximately 59 months

Metastatic hormone-sensitive prostate cancer

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information