OncoMatch/Clinical Trials/NCT05348876
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)
Is NCT05348876 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Darolutamide (Nubeqa, BAY1841788) for non-metastatic castration-resistant prostate cancer.
Treatment: Darolutamide (Nubeqa, BAY1841788) — 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 to ADT are already available, but this study had no Indian patients and was not conducted in India. Therefore, the main purpose of this study is to learn how safe darolutamide is when taken in addition to ADT in Indian participants with high-risk nmCRPC. To answer this question, the researchers will collect all medical problems the participants have that arise during the study and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE). The following information regarding safety of darolutamide will be collected during the study: * the number and severity of AEs that are non-serious or serious * the number of participants who have to permanently stop the treatment due to AEs * the number of participants who have to change the amount of study drug taken due to AEs AEs can be: * abnormal results of laboratory tests, physical examinations, or heart health examinations using ECG (detects heart problems by measuring the electrical activity generated by the heart as it contracts). * relevant changes in vital signs * relevant changes of the participant's daily living abilities (ECOG performance status) These results will then be compared with the results from the previous study to identify any differences for this group of participants. In addition, researchers will collect and compare data on how well darolutamide worked under real world conditions in this group of participants. All participants will take darolutamide as tablets by mouth twice a day. The participants will visit the study center at the start of the study, and then every 16 weeks until their cancer gets worse, they develop medical problems, they leave the study or until the study is terminated. During the study, the study team will * take blood and urine samples * do physical examinations * check vital signs * examine heart health using ECG * assess the participant's ECOG performance status * ask the participants questions about how they are feeling and what AEs they are having. If the trial is stopped, participants may have the option to continue to receive darolutamide, provided they benefit from the treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage NON-METASTATIC
Excluded: Stage IV
History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study treatment based on standard medical imaging
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen deprivation therapy — ongoing
continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy)
Cannot have received: second-generation androgen receptor inhibitor (enzalutamide, apalutamide, darolutamide, proxalutamide)
Prior treatment with: Second-generation androgen receptor (AR) inhibitors (such as enzalutamide, apalutamide, darolutamide, proxalutamide, etc)
Cannot have received: investigational androgen receptor inhibitor
Other investigational AR inhibitors
Cannot have received: CYP17 inhibitor (oral ketoconazole, abiraterone acetate, TAK-700)
Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole, abiraterone acetate, TAK-700, etc)
Cannot have received: first-generation androgen receptor inhibitor (bicalutamide, flutamide, nilutamide, cyproterone acetate)
Exception: within 28 days before first dose of study treatment
Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before first dose of study treatment.
Cannot have received: estrogen
Exception: within 28 days before first dose of study treatment
Use of estrogens ... within 28 days before first dose of study treatment.
Cannot have received: 5-alpha reductase inhibitor (finasteride, dutasteride)
Exception: within 28 days before first dose of study treatment
Use of ... 5-α reductase inhibitors (finasteride, dutasteride) within 28 days before first dose of study treatment.
Cannot have received: chemotherapy
Exception: except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment
Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment.
Cannot have received: immunotherapy
Exception: except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment
Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment.
Cannot have received: systemic corticosteroid (prednisone)
Exception: dose greater than the equivalent 10 mg of prednisone/day within 28 days before first dose of study treatment
Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before first dose of study treatment.
Cannot have received: radiation therapy
Exception: within 12 weeks before first dose of study treatment
Radiation therapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 12 weeks before first dose of study treatment.
Cannot have received: osteoclast-targeted therapy (bisphosphonate, denosumab)
Exception: to prevent skeletal-related events within 4 weeks before first dose of study treatment; allowed for osteoporosis at indicated dose/schedule
Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) to prevent skeletal-related events within 4 weeks before first dose of study treatment. Participants receiving osteoclast-targeted therapy to prevent bone loss at a dose and schedule indicated for osteoporosis may continue treatment at the same dose and schedule.
Cannot have received: investigational drug
Exception: within 28 days before first dose of study treatment
Treatment with any investigational drug within 28 days before first dose of study treatment.
Lab requirements
Blood counts
hemoglobin ≥ 9.0 g/dL, ANC ≥ 1500/μL, platelet count ≥ 100,000/μL (no growth factor or transfusion within 7 days of screening labs)
Kidney function
eGFR > 15 mL/min/1.73 m^2; creatinine ≤ 2.0 × ULN
Liver function
ALT and AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN (except Gilbert's disease)
Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1500/μL (1.5 × 10^9/L), platelet count ≥ 100,000/μL (100 ×10^9/L) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening). Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin (TBL) ≤ 1.5 × ULN (except participants with a diagnosis of Gilbert's disease), creatinine ≤ 2.0 × ULN. Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m^2.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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