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New treatment option for Non-metastatic Castration-resistant Prostate Cancer
Official 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)
ClinicalTrials.gov ID: NCT05348876
What this study is testing
What is Darolutamide (Nubeqa, BAY1841788)?
Darolutamide (Nubeqa, BAY1841788) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Capable of giving signed informed consent.
- Participant must be male aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- Castration resistance, demonstrated by:
- a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured...
You likely can't join if
- History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study...
- Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate...
- Acute toxicities of prior treatments and procedures not resolved to common terminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or...
- Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant...
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before first dose of study treatment.
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent.
- Participant must be male aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- Castration resistance, demonstrated by:
- a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy) and
- the interval between each PSA measurement must be ≥ 1 week, and
- the PSA value at screening must be ≥ 1.0 ng/mL (1.0 μg/L). To confirm this eligibility criterion, it is acceptable for 2 out of the 3 PSA measurements to be taken during the 28-day screening period (after participant...
- Castrate level of serum testosterone (\< 1.7 nmol/L [50 ng/dL]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral...
- PSA doubling time (PSADT) of ≤ 10 months.
- Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1.
- Estimated glomerular filtration rate (eGFR) \> 15 mL/min/1.73 m\^2.
- Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1500/μL (1.5 × 109/L), platelet count ≥ 100,000/μL (100 ×109/L) (participant must not have received any growth factor or blood transfusion...
- 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...
- Sexually active participants, unless surgically sterile, must agree to use a male condom plus partner use of a contraceptive method with a failure rate of \<1% per year, and refrain from sperm donation during the study...
What rules you out
- 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, i.e., computed tomography/...
- Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer.
- Acute toxicities of prior treatments and procedures not resolved to common terminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or baseline before first dose of study treatment.
- Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment.
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before first dose of study treatment.
- Any of the following within 6 months before first dose of study treatment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart...
- Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and...
- End-stage renal disease (eGFR \< 15 mL/min/1.73 m\^2).
- Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as...
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- Unstable active viral hepatitis with a need for treatment.
- Known human immunodeficiency virus (HIV) infection with any of the following (Note: HIV testing is not required unless mandated by local authority):
- CD4+ T-cell (CD4+) count of less than 350 cells/μL
- History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months
- On established antiretroviral therapy for less than 4 weeks
- Presenting with a viral load of more than 400 copies/mL prior to enrollment
- On antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant drug-drug interactions or overlapping toxicities with study treatment and cannot be changed to alternative agents.
- Any condition that, in the opinion of the investigator, would impair the participants' ability to comply with the study procedures or study treatment (e.g., unable to swallow study treatment).
- Unwilling or unable to comply with all protocol-required visits and assessments or comply with study requirements.
- Prior treatment with:
- Second-generation androgen receptor (AR) inhibitors (such as enzalutamide, apalutamide, darolutamide, proxalutamide, etc)
- Other investigational AR inhibitors
- Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole, abiraterone acetate, TAK-700, etc).
- Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before first dose of study treatment.
- Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28 days 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.
- Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before first dose of study treatment.
- Radiation therapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 12 weeks before first dose of study treatment.
- 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...
- Treatment with any investigational drug within 28 days before first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Vijayawada, Andhra Pradesh, India
- Visakhapatnam, Andhra Pradesh, India
- Nadiād, Gujarat, India
- Surat, Gujarat, India
- Belagavi, Karnataka, India
- Bengaluru, Karnataka, India
- Kochi, Kerala, India
- Thiruvananthapuram, Kerala, India
- Vellalasseri, Kerala, India
- Amravati, Maharashtra, India
- Mumbai, Maharashtra, India
- New Delhi, National Capital Territory of Delhi, India
- Bhubaneswar, Odisha, India
- Gorimedu, Puducherry, India
- Bangalore, Punjab, India
- Ludhiana, Punjab, India
- Jaipur, Rajasthan, India
- Erode, Tamil Nadu, India
- Hyderabad, Telangana, India
- Chandigarh, Uttar Pradesh, India
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vijayawada, Andhra Pradesh, India; Visakhapatnam, Andhra Pradesh, India; Nadiād, Gujarat, India; Surat, Gujarat, India; Belagavi, Karnataka, India; Bengaluru, Karnataka, India and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.