What is darolutamide studying for non-metastatic castration-resistant prostate cancer?

Darolutamide is being studied to understand its safety and how well it works when added to standard androgen deprivation therapy in men with high-risk prostate cancer that has not spread. Researchers want to learn about any side effects and treatment effects in Indian participants. This study is sponsored by Bayer and focuses on real-world conditions.

Who may be eligible for this non-metastatic castration-resistant prostate cancer clinical trial?

Men aged 18 years or older with confirmed prostate cancer that is resistant to low testosterone levels may be eligible. Participants should have a PSA level of at least 1.0 ng/mL and no evidence of cancer spread on standard imaging. The study is for male participants only. Please review eligibility criteria for more details.

Is there any cost to participate in this non-metastatic castration-resistant prostate cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 4

Age: 18Years +

MALE

ID05348876

Phase 4 Study of Darolutamide with Standard Androgen Deprivation Therapy for Indian Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

Led by Bayer · Updated on 2026-07-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of darolutamide alongside standard androgen deprivation therapy ADT in Indian men with high-risk non-metastatic castration-resistant prostate cancer nmCRPC. This type of prostate cancer continues to progress despite very low testosterone levels. The study aims to collect detailed safety data and compare it with previous research involving darolutamide, which did not include Indian participants. Participants will take darolutamide tablets orally twice daily along with their ongoing ADT. They will have visits every 16 weeks from the start until their cancer worsens, they develop medical issues, leave the study, or the study ends. During these visits, various tests and assessments will be performed, including blood and urine sampling, physical exams, heart activity monitoring with ECG, and evaluation of daily living abilities using the ECOG performance status. Throughout the study, researchers will monitor adverse events, lab abnormalities, vital signs, and changes in participants health status up to approximately 15 months. They will also assess changes in prostate-specific antigen PSA levels and track the time to additional cancer treatments. Participants may continue darolutamide after the trial if they benefit from it. The total study duration extends up to the primary completion date in April 2027.

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

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male aged 18 years or older
Able to give signed informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Castration resistance shown by at least 3 rising PSA values during continuous ADT started at least 4 weeks prior or after bilateral orchiectomy
PSA values at screening must be at least 1.0 ng/mL, with measurements at least 1 week apart
Castrate level of serum testosterone (<1.7 nmol/L) on GnRH therapy or after bilateral orchiectomy
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
Blood counts at screening meeting specified thresholds without recent growth factors or transfusions
Liver enzymes (ALT and AST) no more than 2.5 times upper limit of normal, bilirubin no more than 1.5 times upper limit (except Gilbert's disease), creatinine no more than 2 times upper limit
Sexually active participants must agree to use male condoms plus partner contraception during and for 1 week after treatment

You will not qualify if you...

History or presence of metastatic disease within 42 days before study treatment by standard imaging
Symptomatic local-regional disease requiring medical intervention such as moderate/severe urinary obstruction or hydronephrosis
Unresolved acute toxicities from prior treatments above CTCAE grade 1
Severe or uncontrolled diseases or infections making participation inappropriate
Known hypersensitivity to darolutamide or its ingredients
Major surgery within 28 days before first study dose
Recent serious cardiovascular events within 6 months before first dose
Uncontrolled hypertension despite medical management
End-stage renal disease (eGFR less than 15 mL/min/1.73 m2)
Prior malignancies except certain treated skin or bladder cancers or cancers with no disease for at least 5 years
Gastrointestinal issues likely to affect drug absorption
Unstable active viral hepatitis needing treatment
Known HIV infection with specific criteria such as low CD4 count or recent opportunistic infection
Conditions impairing ability to comply with study procedures or treatment
Prior use of second-generation androgen receptor inhibitors or certain enzyme inhibitors
Use of first-generation AR inhibitors, estrogens, or 5-alpha reductase inhibitors within 28 days before study
Prior chemotherapy or immunotherapy for prostate cancer within 2 years
Recent systemic corticosteroid use above specified dose
Radiation therapy within 12 weeks before study
Recent use of osteoclast-targeted therapy to prevent skeletal events within 4 weeks
Participation in another investigational drug study within 28 days before first dose

Research Team

Bayer Clinical Trials Contact

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Phase 4 Study of Darolutamide with Standard Androgen Deprivation Therapy for Indian Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria