Study Completed

Metastatic hormone-sensitive prostate cancer

Bayer Identifier:

17777

ClinicalTrials.gov Identifier:

NCT02799602

EudraCT Number:

2015-002590-38

EU CT Number:

Not Available

Darolutamide in addition to standard androgen deprivation therapy and docetaxel in metastatic hormone–sensitive prostate cancer

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

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

November 2016 - April 2023

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Darolutamide+ADT+docetaxel (BAY1841788)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Roma, 152, Italy
Completed		Torino, 10043, Italy
Completed		Tel Aviv, 6423906, Israel
Completed		Zerifin, 7030000, Israel
Completed		Barcelona, 08035, Spain
Completed		BRUXELLES - BRUSSEL, 1200, Belgium
Completed		GENT, 9000, Belgium
Completed		Barcelona, 8036, Spain
Not yet recruiting		Madrid, 28046, Spain
Completed		Córdoba, 14004, Spain
Completed		Sabadell, 08208, Spain
Completed		Brussels, 1070, Belgium
Completed		Berlin, 12203, Germany
Completed		Tübingen, 72076, Germany
Completed		Münster, 48149, Germany
Withdrawn		Köln, 50931, Germany
Completed		Jena, 7747, Germany
Completed		Padova, 35128, Italy
Not yet recruiting		Cortona, 52040, Italy
Completed		Milano, 20141, Italy
Completed		Valencia, 46009, Spain
Not yet recruiting		Dresden, 1307, Germany
Completed		Nürtingen, 72622, Germany
Completed		Rostock, 18107, Germany
Completed		Duarte, 91010, United States
Withdrawn		Syracuse, 13210, United States
Withdrawn		Nashville, 37209, United States
Completed		Boca Raton, 33486, United States
Withdrawn		Philadelphia, 19111-2497, United States
Not yet recruiting		Denver, 80211, United States
Completed		VILLEJUIF CEDEX, 94805, France
Completed		POITIERS, 86021, France
Completed		Saint Herblain Cedex, 44805, France
Completed		ANGERS, 49055, France
Withdrawn		Bydgoszcz, 85-165, Poland
Not yet recruiting		Wroclaw, 50-556, Poland
Completed		Siedlce, 08-110, Poland
Completed		Edmonton, T6G 1Z2, Canada
Completed		Toronto, M4N 3M5, Canada
Completed		Montreal, H2L 4M1, Canada
Completed		Praha 5, 150 06, Czech Republic
Not yet recruiting		Hradec Kralove, 500 05, Czech Republic
Completed		Praha 2, 12808, Czech Republic
Completed		Brno, 65653, Czech Republic
Completed		Praha 2, 120 00, Czech Republic
Completed		Haifa, 3109601, Israel
Completed		Petach Tikva, 4941492, Israel
Completed		Holon, 5822012, Israel
Completed		Beer Sheva, 8410101, Israel
Withdrawn		Jerusalem, 9103102, Israel
Completed		Zefat, 1311001, Israel
Completed		Moscow, 125284, Russia
Completed		Omsk, 644013, Russia
Completed		Moscow, 115478, Russia
Completed		St. Petersburg, 197136, Russia
Completed		Barnaul, 656045, Russia
Completed		Novosibirsk, 630099, Russia
Completed		New Orleans, 70112, United States
Completed		Gahanna, 43230, United States
Withdrawn		Ephrata, 17522-1761, United States
Withdrawn		Seattle, 98101-2756, United States
Withdrawn		New Hyde Park, 11042, United States
Withdrawn		Gilbert, 85234, United States
Completed		Baltimore, 21287, United States
Completed		Omaha, 68130, United States
Withdrawn		New York, United States
Completed		Columbus, 43210, United States
Completed		Oklahoma City, 73104, United States
Withdrawn		Nashville, 37232-0021, United States
Completed		Towson, 21204, United States
Completed		Greenville, 29607, United States
Completed		Boston, 02111, United States
Withdrawn		Aurora, 80045, United States
Completed		Dallas, 75231, United States
Not yet recruiting		Concord, 28025, United States
Completed		Tucson, 85724, United States
Completed		PIERRE BENITE, 69495, France
Withdrawn		CAEN CEDEX 5, 14076, France
Not yet recruiting		PARIS cedex 5, 75248, France
Completed		CERGY PONTOISE, 95303, France
Completed		Varna, 9010, Bulgaria
Completed		Vratsa, 3000, Bulgaria
Completed		Seoul, 06351, Korea,_republic_of
Completed		Seoul, 6273, Korea,_republic_of
Completed		Seoul, 05505, Korea,_republic_of
Completed		Seoul, 3080, Korea,_republic_of
Completed		Lublin, 20-362, Poland
Completed		Boston, 02114-2696, United States
Withdrawn		Moscow, 119435, Russian Federation
Completed		Taipei, 100, Taiwan
Completed		Taoyuan, 33305, Taiwan
Completed		Taipei, 11217, Taiwan
Completed		Taichung, 404327, Taiwan
Completed		Kaohsiung City, 807377, Taiwan
Completed		Kurralta Park, 5037, Australia
Completed		Helsinki, 00029, Finland
Completed		Kuopio, FIN- 70029, Finland
Completed		Oulu, 90220, Finland
Withdrawn		Richmond, 3121, Australia
Completed		London, NW1 2PG, United Kingdom
Completed		Colchester, CO45JR, United Kingdom
Completed		Middlesborough, TS43BW, United Kingdom
Completed		London, SW3 6JJ, United Kingdom
Withdrawn		Oxford, OX3 7LJ, United Kingdom
Completed		Romford, RM7 0AG, United Kingdom
Completed		Seoul, 137-701, Korea,_republic_of
Completed		Gwangju, 501-757, Korea,_republic_of
Completed		Barcelona, 08003, Spain
Completed		Malaga, 29010, Spain
Completed		Madrid, 28041, Spain
Completed		Daegu, 700721, Korea,_republic_of
Completed		Belfast, BT9 7AB, United Kingdom
Completed		Toronto, M5G 2M9, Canada
Completed		Shanghai, 200000, China
Completed		Nanjing, 210008, China
Completed		Nanjing, 210000, China
Withdrawn		Nedlands, 6009, Australia
Completed		Sofia, 1784, Bulgaria
Completed		Sofia, 1303, Bulgaria
Completed		Pleven, 5809, Bulgaria
Completed		Busan, 47392, Korea,_republic_of
Withdrawn		Englewood, 80113-2766, United States
Completed		Washington, 20007, United States
Completed		Winston-Salem, 27157, United States
Completed		Brno, 656 91, Czech Republic
Completed		Sydney, 2031, Australia
Not yet recruiting		Kaohsiung, 833, Taiwan
Completed		Pittsburgh, 15212, United States
Completed		Xi'an, 710061, China
Completed		Tianjin, 300000, China
Completed		Shenyang, 110001, China
Completed		Magdeburg, 39120, Germany
Withdrawn		Homburg, 66421, Germany
Completed		Freiburg, 79106, Germany
Completed		Bologna, 40138, Italy
Withdrawn		St. Petersburg, 197022, Russian Federation
Completed		Reims, 51726, France
Completed		Lodz, 90-302, Poland
Not yet recruiting		Beijing, 100730, China
Completed		Nanchang, 330006, China
Completed		Myrtle Beach, 29579, United States
Completed		Detroit, 48202, United States
Completed		Charlottesville, 22903, United States
Completed		New York, 10032, United States
Completed		Louisville, 40202, United States
Withdrawn		Seattle, 98109-1023, United States
Withdrawn		Scottsdale, 85259-5452, United States
Withdrawn		Providence, 02906, United States
Completed		Gainesville, 32610, United States
Completed		STRASBOURG, 67033, France
Completed		Changsha, 410013, China
Completed		Beijing, 100730, China
Completed		Guangzhou, 510120, China
Completed		Wuhan, 430079, China
Completed		Shanghai, 200072, China
Completed		Jinan, 250021, China
Completed		Hilversum, 1213 VG, Netherlands
Completed		Los Angeles, 90073, United States
Completed		Bruxelles, 1070, Belgium
Completed		Everett, 98201, United States
Completed		Minato-ku, 105-8471, Japan
Completed		Bunkyo-ku, 113-8431, Japan
Completed		Shinjuku-ku, 162-8543, Japan
Completed		Yokohama, 232-0024, Japan
Completed		Chiba-shi, 260-8677, Japan
Completed		Kashiwa, 277-8577, Japan
Completed		Osaka-shi, 541-8567, Japan
Completed		Sakai, 590-0197, Japan
Completed		Kita-gun, 761-0793, Japan
Completed		Sendai, 980-8574, Japan
Completed		Umea, 901 85, Sweden
Completed		Goteborg, 413 45, Sweden
Completed		Uppsala, 751 85, Sweden
Completed		Chelyabinsk, 454048, Russia
Completed		Seoul, 03722, Korea,_republic_of
Completed		Lebanon, 03756, United States
Completed		Rochester, 14642, United States
Completed		Tampa, 33612, United States
Completed		Falls Church, 22042, United States
Completed		Buffalo, 14203, United States
Completed		Seongnam-si, 13620, Korea,_republic_of
Completed		Rybnik, 44-200, Poland
Completed		Hefei City, Anhui Province, 230031, China
Completed		Shanghai, 200092, China
Completed		Shanghai, 200040, China
Completed		Tampere, 33520, Finland
Not yet recruiting		Poznan, 60-569, Poland
Completed		Hackensack, 07601, United States
Completed		London, W6 8RF, United Kingdom
Completed		GILLY, 6060, Belgium
Completed		Shijiazhuang, 50000, China
Completed		Hangzhou, 310014, China
Completed		Shengyang, 110042, China
Completed		Xiamen, 361003, China
Completed		seoul, 02841, Korea,_republic_of
Completed		Temple, 76508, United States
Withdrawn		Hershey, 17033, United States
Completed		MARSEILLE, 13273, France
Completed		NANCY, 54100, France
Completed		Trento, 38100, Italy
Completed		Lund, 222 42, Sweden
Completed		Jyväskylä, 40620, Finland
Not yet recruiting		Düsseldorf, 40225, Germany
Withdrawn		Newnan, 30265, United States
Completed		Adelaide, 5000, Australia
Completed		Geleen, 6162 BG, Netherlands
Not yet recruiting		NIJMEGEN, 6525 GA, Netherlands
Completed		DEN HAAG, 2545 CH, Netherlands
Not yet recruiting		Miami Beach, 33140, United States
Completed		Milwaukee, 53226, United States
Withdrawn		Burlington, 1805, United States
Completed		Billings, 59102, United States
Completed		Atlanta, 30322, United States
Withdrawn		Bari, 70124, Italy
Completed		Wilrijk, 2610, Belgium
Completed		Camp Hill, 17011, United States
Completed		North Charleston, 29406, United States
Withdrawn		México, 14080, Mexico
Completed		Monterrey, 64460, Mexico
Completed		Cuernavaca, 62290, Mexico
Completed		Ciudad de Mexico, 6760, Mexico
Completed		México, D. F., 6760, Mexico
Completed		Stockholm, 171 76, Sweden
Not yet recruiting		Plovdiv, 4004, Bulgaria
Completed		Sofia, 1431, Bulgaria
Completed		Porto Alegre, 90020-090, Brazil
Completed		Curitiba, 81520-060, Brazil
Not yet recruiting		Sao Paulo, 01308-050, Brazil
Not yet recruiting		Belo Horizonte, 30150-320, Brazil
Withdrawn		Sao Paulo, 05651-901, Brazil
Completed		Cachoeiro de Itapemirim, 29308-020, Brazil
Completed		São Paulo, 04014-002, Brazil
Completed		Santo André, 09060-650, Brazil
Completed		Salvador, 41253-190, Brazil
Not yet recruiting		São Paulo, 01246-000, Brazil
Not yet recruiting		Belo Horizonte, 30130-100, Brazil
Completed		Rio de Janeiro, 22793-080, Brazil
Completed		Rio de Janeiro, 20231-050, Brazil
Completed		Poughkeepsie, 12603, United States
Withdrawn		New Haven, 06520, United States
Completed		Camden, 08103, United States
Completed		Bala Cynwyd, 19004, United States
Completed		Matsuyama, 791-0280, Japan
Completed		Sapporo, 003-0804, Japan
Completed		Kobe, 650-0017, Japan
Completed		Osaka, 545-8586, Japan
Completed		Shanghai, 200080, China
Completed		Wenzhou, 325000, China
Completed		Beijing, 100142, China
Completed		Guri-si, 471-701, Korea,_republic_of
Completed		CLERMONT-FERRAND, 63011, France
Completed		Richmond, 23284, United States
Completed		Palo Alto, 94304, United States
Completed		Cleveland, 44106, United States
Withdrawn		Houston, 77030, United States
Completed		Chicago, 60611, United States
Completed		Peoria, 61615, United States
Completed		Sakura, 285-8741, Japan
Completed		Hamamatsu, 431-3192, Japan
Completed		Bunkyo-ku, 113-8655, Japan
Completed		Calgary, T2N 4N2, Canada
Completed		Yonago, 683-8504, Japan
Completed		Utsunomiya, 321-0974, Japan
Completed		Kanazawa, 920-8641, Japan
Completed		Chiba, 260-8717, Japan
Withdrawn		Roma, 00161, Italy
Completed		Nagoya, 466-8560, Japan
Completed		Suita, 565-0871, Japan
Completed		Mitaka, 181-8611, Japan
Completed		Koto-ku, 135-8550, Japan
Completed		Bunkyo-Ku, 113-0022, Japan
Withdrawn		Mexico, D.F., 14050, Mexico
Completed		Tsu, 514-8507, Japan
Completed		Mikkeli, FIN-50100, Finland
Completed		Warszawa, 02-781, Poland
Completed		Fukuoka, 811-1395, Japan
Completed		Ube, 755-8505, Japan
Completed		Kashihara, 634-8522, Japan
Completed		Miyazaki, 889-1692, Japan
Completed		Shimotsuke, 329-0498, Japan
Completed		Kumamoto, 860-0008, Japan
Completed		Kanazawa, 920-8530, Japan
Completed		Okayama-city, 700-8558, Japan
Completed		Nakano-ku, 164-8541, Japan
Completed		Shinjuku-ku, 160-8582, Japan
Withdrawn		Changsha, 410011, China
Completed		Waliszew, 05-135, Poland
Completed		Yokohama, 241-8515, Japan
Completed		Hirosaki, 036-8563, Japan
Not yet recruiting		Durango, 34000, Mexico
Withdrawn		Cuautitlan Izcalli, 54769, Mexico
Completed		Mazatlán, 82110, Mexico
Completed		Jerusalem, 9112001, Israel
Completed		Fitzroy, 3065, Australia
Completed		Parma, 43126, Italy
Completed		Beijing, 100050, China
Completed		Wakayama, 640-8558, Japan
Completed		Nagasaki, 852-8501, Japan
Completed		Tokushima, 770-8503, Japan
Completed		Asahi, 289-2511, Japan
Completed		Santiago de Querétaro, 76000, Mexico
Completed		MONTPELLIER CEDEX, 34298, France
Completed		Creteil, 94010, France
Completed		Meguro-ku, 152-8902, Japan
Completed		BESANCON, 25030, France
Completed		Gifu, 500-8717, Japan
Completed		Praha 8, 180 81, Czech Republic
Completed		Turku, 20520, Finland
Completed		Praha 10, 10034, Czech Republic
Completed		Glasgow, G12 0YN, United Kingdom
Completed		Gabrovo, 5300, Bulgaria
Completed		Sydney, 2010, Australia
Completed		Hoofddorp, 2134 TM, Netherlands
Completed		AMSTERDAM, 1066 CX, Netherlands
Completed		AMSTERDAM, 1081 HV, Netherlands
Completed		DORDRECHT, 3318 AT, Netherlands
Completed		Charleston, 29414, United States
Completed		Englewood, 07361, United States
Completed		Chandler, 85224, United States
Completed		Braunschweig, 38126, Germany
Completed		Ulm, 89075, Germany
Completed		Barcelona, 8041, Spain
Completed		Palma De Mallorca, 7120, Spain
Completed		Lugo, 27003, Spain
Completed		Cáceres, 10003, Spain
Completed		Erlangen, 91054, Germany
Completed		Tilburg, 5042 AD, Netherlands
Completed		Natal, 59040-000, Brazil
Completed		Verona, 37134, Italy
Withdrawn		Madrid, 28009, Spain
Completed		Beijing, 100034, China
Completed		Yantai, 264000, China
Completed		Wuhan, 430030, China
Completed		Tianjin, 300052, China
Completed		Shanghai, 200032, China
Completed		Zhengzhou, 450000, China
Completed		Chongqing, 400030, China
Not yet recruiting		Antwerp, 2020, Belgium
Withdrawn		Stockholm, 118 83, Sweden
Completed		Changchun City, 130061, China
Completed		Salt Lake City, 84112, United States
Completed		Bronx, 14061, United States
Completed		Boston, 02215, United States
Completed		Chelyabinsk, 454087, Russia
Completed		Novara, 28100, Italy
Completed		SAINT-GREGOIRE, 35760, France
Withdrawn		PARIS, 75674, France
Completed		Bordeaux Cedex, 33076, France
Completed		St. Petersburg, 188663, Russia
Completed		St. Petersburg, 194017, Russia
Completed		Beijing, 100142, China
Completed		NAMUR, 5000, Belgium
Completed		Beverly Hills, 90211, United States
Completed		Jinan, 250000, China
Completed		Charleston, 29401, United States
Completed		BREST, 29200, France
Not yet recruiting		DIJON, 21000, France
Not yet recruiting		SAINT MANDE, 94160, France
Completed		Albuquerque, 87109, United States
Completed		Beijing, 100083, China
Completed		Hangzhou, 310009, China
Completed		Madrid, 28034, Spain
Completed		Kettering, 45409, United States

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.
Time Frame:
From randomization of the first subject until death from any cause up to the time 533 OS events were reached (approximately 59 months)
Safety Issue:
No

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.
Time Frame:
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
Time Frame:
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.
Time Frame:
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
Time Frame:
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.
Time Frame:
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
Time Frame:
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.
Time Frame:
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.
Time Frame:
From randomization of the first subject to the first opioid use for ≥7 consecutive days up to approximately 59 months

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

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards Click here to find information about studies related to Bayer Healthcare products conducted in Europe Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer: A Patient and Caregiver Perspective and Plain Language Summary of the ARASENS Trial