New hope for indian men with aggressive prostate cancer: darolutamide trial launches

NCT ID NCT05348876

Recruiting now Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 4 times

Summary

This study tests darolutamide, a drug that blocks male hormones fueling prostate cancer, in Indian men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). All 50 participants will take darolutamide pills twice a day along with standard hormone therapy. The main goal is to check safety and side effects, and to see how well the drug works in this specific population. The trial is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Darolutamide (Nubeqa)
What this could lead to: If successful, this study could confirm that darolutamide is safe and effective for Indian men with high-risk prostate cancer that hasn't spread, potentially expanding treatment options in India.
What could go wrong: This is a small, single-arm phase 4 study with no placebo group, so results may not be definitive. Side effects like fatigue, high blood pressure, or falls are possible. The cancer may still progress.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Contacts and locations

Locations

All India Institute of Medical Sciences
RECRUITING

Bhubaneswar, Odisha, 751019, India
Amrita Institute of Medical Sciences
RECRUITING

Kochi, Kerala, 682041, India
Apollo Research Foundation
COMPLETED

Hyderabad, Telangana, 500096, India
Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital
TERMINATED

Bangalore, Punjab, 560001, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
COMPLETED

Jaipur, Rajasthan, 302017, India
Dayanand Medical College & Hospital
WITHDRAWN

Ludhiana, Punjab, 141001, India
Dr. RML Hospital & PGIMER
COMPLETED

New Delhi, National Capital Territory of Delhi, 110001, India
Erode Cancer Centre
TERMINATED

Erode, Tamil Nadu, 638012, India
Fortis Hospital Bangalore
TERMINATED

Bengaluru, Karnataka, 560076, India
HCG Oncology Center
COMPLETED

Bengaluru, Karnataka, 560027, India
HCG-City Cancer Centre
TERMINATED

Vijayawada, Andhra Pradesh, 520004, India
Jawaharlal Institute Of Postgraduate Medical Education and R
COMPLETED

Gorimedu, Puducherry, 605006, India
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
WITHDRAWN

Belagavi, Karnataka, 590010, India
King George Hospital
TERMINATED

Visakhapatnam, Andhra Pradesh, 530002, India
MNJ Institute of Oncology & Regional Cancer Centre
TERMINATED

Hyderabad, Telangana, 500004, India
MVR Cancer Centre and Research Institute
RECRUITING

Vellalasseri, Kerala, 673601, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre
RECRUITING

Varanasi, Uttar Pradesh, 221005, India
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital)
COMPLETED

Nadiād, Gujarat, 387001, India
Netaji Subhas Chandra Bose Cancer Hospital
RECRUITING

Kolkata, West Bengal, 700094, India
Post Graduate Institute of Medical Education and Research
WITHDRAWN

Chandigarh, Uttar Pradesh, 160012, India
Rajiv Gandhi Cancer Institute & Research Centre
RECRUITING

New Delhi, National Capital Territory of Delhi, 110085, India
Regional Cancer Centre - Thiruvananthapuram
RECRUITING

Thiruvananthapuram, Kerala, 695011, India
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
COMPLETED

Amravati, Maharashtra, 444605, India
Surat Institute of Digestive Sciences
TERMINATED

Surat, Gujarat, 395002, India
Tata Memorial Hospital
RECRUITING

Mumbai, Maharashtra, 400012, India

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