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)

PHASE4RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 3, 2022

Primary Completion Date

January 28, 2026

Study Completion Date

January 28, 2026

Conditions
Non-metastatic Castration-resistant Prostate Cancer
Interventions
DRUG

Darolutamide (Nubeqa, BAY1841788)

600 mg (two 300 mg) tablets of darolutamide to be taken orally twice a day at about 12-hour intervals, equivalent to a total daily dose of 1200 mg.

Trial Locations (25)

110001

COMPLETED

Dr. RML Hospital & PGIMER, New Delhi

141001

WITHDRAWN

Dayanand Medical College & Hospital, Ludhiana

160012

WITHDRAWN

Post Graduate Institute of Medical Education and Research, Chandigarh

221005

RECRUITING

Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi

302017

COMPLETED

Bhagwan Mahaveer Cancer Hospital & Research Centre, Jaipur

387001

COMPLETED

Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital), Nadiād

395002

TERMINATED

Surat Institute of Digestive Sciences, Surat

400012

RECRUITING

Tata Memorial Hospital, Mumbai

444605

COMPLETED

Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, Amravati

500096

COMPLETED

Apollo Research Foundation, Hyderabad

520004

TERMINATED

HCG-City Cancer Centre, Vijayawada

560001

TERMINATED

Victoria Hospital, Bangalore

560027

COMPLETED

HCG Oncology Center, Bengaluru

560076

TERMINATED

Fortis Hospital Bangalore, Bengaluru

590010

WITHDRAWN

KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi

605006

COMPLETED

Jawaharlal Institute Of Postgraduate Medical Education and R, Gorimedu

638012

TERMINATED

Erode Cancer Centre, Erode

673601

RECRUITING

MVR Cancer Centre and Research Institute, Vellalasseri

695011

RECRUITING

Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram

700094

RECRUITING

Netaji Subhas Chandra Bose Cancer Hospital, Kolkata

751019

RECRUITING

All India Institute of Medical Sciences, Bhubaneswar

500 004

TERMINATED

MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad

Unknown

TERMINATED

King George Hospital, Visakhapatnam

110 085

RECRUITING

Rajiv Gandhi Cancer Institute & Research Centre, New Delhi

682 041

RECRUITING

Amrita Institute of Medical Sciences, Kochi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY