Actively Recruiting
A Study of Darolutamide Added to Standard Androgen Deprivation Therapy in Indian Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Led by Bayer · Updated on 2026-05-18
50
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how safe the drug darolutamide is when added to standard androgen deprivation therapy (ADT) for men in India with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer does not spread to other parts of the body but continues to grow even when male hormones like testosterone are lowered. The study aims to collect information about side effects and how darolutamide works in this specific population, as previous studies did not include Indian patients. Participants will take darolutamide tablets by mouth twice daily along with their usual ADT treatment. They will visit the study center every 16 weeks until their cancer worsens, medical issues develop, they leave the study, or the study ends. During the study, blood and urine samples will be collected, physical exams and heart tests (ECG) will be done, vital signs and daily living abilities will be checked, and participants will be asked about side effects. The researchers will monitor adverse events, including serious and non-serious effects, treatment changes due to side effects, and changes in lab tests, heart health, and physical condition over about 15 months. They will also track prostate-specific antigen (PSA) levels as a marker of cancer activity and the time until additional cancer treatments are needed. If the trial stops, participants may continue darolutamide if they benefit from it.
CONDITIONS
Brief Title
A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participant aged 18 years or older
- Able to give signed informed consent
- Confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- Castration-resistant prostate cancer with at least 3 rising PSA values on continuous ADT
- PSA value at screening of at least 1.0 ng/mL
- Castrate level of serum testosterone below 1.7 nmol/L
- PSA doubling time of 10 months or less
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated glomerular filtration rate (eGFR) greater than 15 mL/min/1.73 m²
- Adequate blood counts and liver function tests
- Agree to use effective contraception if sexually active and not surgically sterile
You will not qualify if you...
- History or evidence of metastatic disease on standard imaging within 42 days prior to treatment
- Symptomatic local-regional disease requiring medical intervention
- Unresolved acute toxicities from prior treatments above CTCAE grade 1
- Severe or uncontrolled diseases or infections
- Known allergy to study treatment or its ingredients
- Major surgery within 28 days before study treatment
- Recent serious cardiovascular events within 6 months before treatment
- Uncontrolled hypertension despite treatment
- End-stage renal disease (eGFR below 15 mL/min/1.73 m²)
- Prior malignancies except certain treated skin or bladder cancers
- Gastrointestinal disorders affecting drug absorption
- Unstable active viral hepatitis
- Known HIV infection with specific criteria
- Inability to comply with study procedures or swallow study drug
- Prior treatment with second-generation androgen receptor inhibitors or certain other medications
- Use of first-generation androgen receptor inhibitors, estrogens, or 5-alpha reductase inhibitors within 28 days before treatment
- Prior chemotherapy or immunotherapy for prostate cancer within 2 years
- Recent use of systemic corticosteroids above prednisone 10 mg/day
- Radiation therapy within 12 weeks before treatment
- Use of certain bone-targeted therapies within 4 weeks before treatment
- Treatment with investigational drugs within 28 days before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 months
Participants receive darolutamide tablets orally twice a day in addition to standard androgen deprivation therapy to treat high-risk non-metastatic castration-resistant prostate cancer.
Regular visits during treatment as per study protocol
Trial Site Locations
Total: 25 locations
1
HCG-City Cancer Centre
Vijayawada, Andhra Pradesh, India, 520004
Terminated
2
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 530002
Terminated
3
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital)
Nadiād, Gujarat, India, 387001
Completed
4
Surat Institute of Digestive Sciences
Surat, Gujarat, India, 395002
Terminated
5
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India, 590010
Withdrawn
6
HCG Oncology Center
Bengaluru, Karnataka, India, 560027
Completed
7
Fortis Hospital Bangalore
Bengaluru, Karnataka, India, 560076
Terminated
8
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682041
Actively Recruiting
9
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, India, 695011
Actively Recruiting
10
MVR Cancer Centre and Research Institute
Vellalasseri, Kerala, India, 673601
Actively Recruiting
11
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
Amravati, Maharashtra, India, 444605
Completed
12
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
13
Dr. RML Hospital & PGIMER
New Delhi, National Capital Territory of Delhi, India, 110001
Completed
14
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, National Capital Territory of Delhi, India, 110085
Actively Recruiting
15
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
16
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Puducherry, India, 605006
Completed
17
Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital
Bangalore, Punjab, India, 560001
Terminated
18
Dayanand Medical College & Hospital
Ludhiana, Punjab, India, 141001
Withdrawn
19
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, Rajasthan, India, 302017
Completed
20
Erode Cancer Centre
Erode, Tamil Nadu, India, 638012
Terminated
21
MNJ Institute of Oncology & Regional Cancer Centre
Hyderabad, Telangana, India, 500004
Terminated
22
Apollo Research Foundation
Hyderabad, Telangana, India, 500096
Completed
23
Post Graduate Institute of Medical Education and Research
Chandigarh, Uttar Pradesh, India, 160012
Withdrawn
24
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, Uttar Pradesh, India, 221005
Actively Recruiting
25
Netaji Subhas Chandra Bose Cancer Hospital
Kolkata, West Bengal, India, 700094
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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