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Study identifier: NCT05348876 Synced from ClinicalTrials.gov · July 29, 2026
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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)

Condition: Non-metastatic Castration-resistant Prostate Cancer  ·  Sponsor: Bayer

PhasePhase 4
Planned participants50
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

Researchers are looking for a better way to treat men who have non-metastatic castration-resistant prostate cancer (nmCRPC). This is a type of cancer of the prostate that has not yet spread to other parts of the body and that keeps progressing even when the amount of male sex hormones like testosterone (also called androgens) is reduced to very low levels. To reduce androgen levels in prostate cancer patients, androgen deprivation therapy (ADT) is often used. As androgens stimulate the growth of prostate cancer cells, low levels are needed to reduce or slow the growth of these tumors. In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). Prostate-specific antigen (PSA) is a protein that is made by both normal cells and by cancerous cells in the body. Thus, PSA levels can be taken as a marker for prostate cancer development. Men with nmCRPC usually have higher levels of (PSA) than normal. They are considered "high risk" if they show signs of quickly increasing PSA levels as this could mean that the tumor is growing and might spread to other parts of the body. The study treatment darolutamide is already available in certain countries for doctors to prescribe to men with prostate cancer that has not yet spread to other parts of the body. It works by blocking androgens from attaching to proteins in cancer cells in the prostate. Results of a previous study in men with high-risk nmCRPC who received darolutamide in addition t…

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

Always discuss trial participation with your own doctor first.

Locations (25)

HCG-City Cancer CentreVijayawada, Andhra Pradesh, IndiaTerminated
King George HospitalVisakhapatnam, Andhra Pradesh, IndiaTerminated
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital)Nadiād, Gujarat, IndiaCompleted
Surat Institute of Digestive SciencesSurat, Gujarat, IndiaTerminated
KLES Dr. Prabhakar Kore Hospital & Medical Research CentreBelagavi, Karnataka, IndiaWithdrawn
HCG Oncology CenterBengaluru, Karnataka, IndiaCompleted
Fortis Hospital BangaloreBengaluru, Karnataka, IndiaTerminated
Amrita Institute of Medical SciencesKochi, Kerala, IndiaRecruiting
Regional Cancer Centre - ThiruvananthapuramThiruvananthapuram, Kerala, IndiaRecruiting
MVR Cancer Centre and Research InstituteVellalasseri, Kerala, IndiaRecruiting
Sujan Surgical Cancer Hospital & Amravati Cancer FoundationAmravati, Maharashtra, IndiaCompleted
Tata Memorial HospitalMumbai, Maharashtra, IndiaRecruiting

+ 13 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05348876