Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Launched by BAYER · Jan 29, 2021
Trial Information
Current as of May 17, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a medication called darolutamide when added to standard treatment for men with metastatic hormone-sensitive prostate cancer. Metastatic means that the cancer has spread beyond the prostate to other parts of the body. The standard treatment being used is called androgen deprivation therapy (ADT), which helps lower levels of male hormones that can promote cancer growth.
To participate in the trial, men aged 65 to 74 with confirmed prostate cancer that has spread are eligible, as long as they have started ADT within the last 12 weeks and meet other health criteria. Participants will receive either darolutamide in addition to their current treatment or just the standard ADT alone. Throughout the trial, participants will be monitored for any side effects and how well the treatment is working. It’s important to know that certain health conditions and previous treatments could prevent someone from joining the study, so discussing eligibility with a healthcare provider is essential.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Histologically or cytologically confirmed adenocarcinoma of prostate
- • Metastatic disease
- • Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
- • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- • Adequate bone marrow, liver and renal function
- Exclusion Criteria:
- • Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
- • Treatment with radiotherapy within 2 weeks before randomization
- • Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
- • 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)
- • Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
- • A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
- • Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
- • Inability to swallow oral medications
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taipei, , Taiwan
Heidelberg, Victoria, Australia
Hamilton, , New Zealand
Kingswood, New South Wales, Australia
Cádiz, , Spain
Sevilla, , Spain
Taichung, , Taiwan
Cape Town, Western Cape, South Africa
Beijing, , China
Tainan, , Taiwan
Alcorcón, Madrid, Spain
New Delhi, Delhi, India
Chelyabinsk, , Russian Federation
Hamilton, , New Zealand
Burlington, Ontario, Canada
Beijing, , China
Beijing, Beijing, China
Beijing, , China
Guangzhou, Guangdong, China
Chandigarh, , India
Mumbai, Maharashtra, India
Ivanovo, , Russian Federation
Kochi, Kerala, India
Barretos, Sao Paulo, Brazil
Pune, Maharashtra, India
Sabadell, Barcelona, Spain
Madrid, , Spain
Frankston, Victoria, Australia
Xi'an, Shaanxi, China
Mumbai, Maharashtra, India
Madurai, Tamil Nadu, India
Daugavpils, , Latvia
Nashik, Maharashtra, India
Kaohsiung City, , Taiwan
Valmiera, , Latvia
Changsha, Hunan, China
Montreal, Quebec, Canada
Fuzhou, Fujian, China
Porto Alegre, Rio Grande Do Sul, Brazil
Cáceres, , Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Málaga, , Spain
Cape Town, , South Africa
Riga, , Latvia
Chelyabinsk, , Russian Federation
Guangzhou, Guangdong, China
Shanghai, , China
Yantai, Shandong, China
Hefei, Anhui, China
Heidelberg, , Australia
Hangzhou, Zhejiang, China
Xiamen, Fujian, China
Wenzhou, Zhejiang, China
Porto Alegre, Rio Grande Do Sul, Brazil
Beijing, , China
Guangzhou, Guangdong, China
Ningbo, Zhejiang, China
Wuhan, Hubei, China
St Leonards, New South Wales, Australia
Yekaterinburg, , Russian Federation
Porto Alegre, Rio Grande Do Sul, Brazil
Oulu, , Finland
Sydney, New South Wales, Australia
Xi'an, Shanxi, China
Kyiv, , Ukraine
Wuhan, Hubei, China
Madurai, Tamil Nadu, India
Beijing, , China
Vilnius, , Lithuania
Novosibirsk, , Russian Federation
Macquarie University, New South Wales, Australia
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São José Do Rio Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Chengdu, Sichuan, China
Mumbai,, Maharashtra, India
Gorimedu, Pondicherry, India
Arkhangelsk, , Russian Federation
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Moscow, , Russian Federation
Sydney, New South Wales, Australia
Nantong, Jiangsu, China
Hangzhou, Zhejiang, China
Shanghai, , China
Helsinki, , Finland
Omsk, , Russian Federation
Ufa, , Russian Federation
Port Elizabeth, Eastern Cape, South Africa
Changhua, , Taiwan
Cherkasy, , Ukraine
Kunming, Yunnan, China
Vilnius, , Lithuania
Novosibirsk, , Russian Federation
Christchurch, , New Zealand
Kolkata, , India
Nanjing, Jiangsu, China
Pretoria, Gauteng, South Africa
Natal, Rio Grande Do Norte, Brazil
Klaipeda, , Lithuania
Wuhan, Hubei, China
Bhubaneswar, Odisha, India
Hamilton, Waikato, New Zealand
Shengyang, Liaoning, China
Helsinki, , Finland
Nizhny Novgorod, , Russian Federation
Barcelona, , Spain
Riga, , Latvia
Ahmedabad, Gujarat, India
Bengaluru, Karnataka, India
Bhubaneswar, Orissa, India
Madurai, Tamil N?Du, India
Santiago, , Chile
Nashik, , India
Adelaide, South Australia, Australia
St. Petersburg, , Russian Federation
Chengdu, Sichuan, China
Seinäjoki, , Finland
Tampere, , Finland
St. Petersburg, , Russian Federation
Chandigarh, Punjab, India
Curitiba, Parana, Brazil
São Paulo, Sao Paulo, Brazil
Granby, Quebec, Canada
Novosibirsk, , Russian Federation
Tyumen, , Russian Federation
Dnipro, , Ukraine
Kyiv, , Ukraine
São Paulo, Sao Paulo, Brazil
Tauranga, , New Zealand
Changchun, Jilin, China
Kaunas, , Lithuania
Ufa, , Russian Federation
Kaohsiung, Sanmin District, Taiwan
South Terrace, South Australia, Australia
Salvador, Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Pelotas, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Abbotsford, British Columbia, Canada
Gatineau, Quebec, Canada
Antofagasta, Araucanía, Chile
Temuco, Araucanía, Chile
Valdivia, Los Lagos, Chile
Providencia, Santiago, Chile
Viña Del Mar, Valparaíso, Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Shenzhen, Guangdong, China
Suzhou, Jiangsu, China
Shanghai, , China
Vishakapatnam, Andhra Pradesh, India
Ahmedabad, Gujarat, India
Vadodara, Gujarat, India
Belagavi, Karnataka, India
Thiruvananthapuram, Kerala, India
Aurangabad, Maharashtra, India
Mumbai, Maharashtra, India
Ludhiana, Punjab, India
Jaipur, Rajasthan, India
Madurai, Tamil N?Du, India
Chennai, Tamil Nadu, India
New Delhi, , India
Riga, , Latvia
Hamilton, , New Zealand
La Victoria, Lima, Peru
San Isidro, Lima, Peru
Lima, , Peru
Lima, , Peru
Moscow, , Russian Federation
Saransk, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Vologda, , Russian Federation
Johannesburg, Gauteng, South Africa
Kyiv, , Ukraine
Natal, Rio Grande Do Norte, Brazil
Hangzhou, Zhejiang, China
St. Petersburg, , Russian Federation
Salvador, Bahia, Brazil
Barretos/Sp, Sao Paulo, Brazil
São Paulo/Sp, Sao Paulo, Brazil
Montreal, Quebec, Canada
Sevilla, , Spain
Málaga, , Spain
Cherkasy, , Ukraine
Natal, Rio Grande Do Norte, Brazil
Zaporizhia, , Ukraine
Natal, Rio Grande Do Norte, Brazil
Hefei City, Anhui Province, Anhui, China
São José Do Rio Preto, Sao Paulo, Brazil
Guangzhou, Guangdong, China
Barretos/Sp, Sao Paulo, Brazil
Bhubaneswar, Delhi, India
Beijing, , China
Barretos/Sp, Sao Paulo, Brazil
Belgaum, Karnataka, India
Providencia, Santiago, Chile
Shenzhen, Guangdong, China
Jaipur, Rajasthan, India
Santiago De Surco, Lima, Peru
Kyiv, , Ukraine
Porto Alegre, Rio Grande Do Sul, Brazil
Santiago, , Chile
Wuhan, Hubei, China
Pretoria, Gauteng, South Africa
Barcelona, , Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Chengdu, Sichuan, China
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Kyiv, , Ukraine
Christchurch, Canterbury, New Zealand
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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