Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Darolutamide BAY 1841788: Approximately 50 participants will be enrolled to receive darolutamide 600 mg (two 300 mg tablets) taken orally, twice daily (BID), equivalent to a total daily
Sponsors
Bayer Consumer Care AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed IC which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol; and providing signed IC. 2. Participant must be male aged ââ?°Â¥ 18 years. 3. Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features. 4. CRPC defined as 3 rising PSA levels after the nadir taken at least 1 week apart during ADT. If the participant has a history of antiandrogen use, the most recent PSA value must be obtained at least 4 weeks after antiandrogen withdrawal. 5. Castrate level of serum testosterone ( releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral orchiectomy must continue GnRH therapy during the study. 6. PSADT of ââ?°Â¤ 10 months and PSA ââ?°Â¥ 2 ng/mL at screening. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 8. Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m2 9. Blood counts at screening: hemoglobin ââ?°Â¥ 9.0 g/dL, absolute neutrophil count ââ?°Â¥ 1500/Ã?¼L (1.5 Ã?â?? 109/L), platelet count ââ?°Â¥ 100,000/Ã?¼L (100 Ã?â??109/L) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening). 10. Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ââ?°Â¤ 2.5 Ã?â?? upper limit of normal (ULN), total bilirubin ââ?°Â¤ 1.5 Ã?â?? ULN (except participants with a diagnosis of Gilbertââ?¬•s disease), creatinine ââ?°Â¤ 2.0 Ã?â?? ULN. 11. 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 donation during the study treatment and for 1 week after the last dose of study treatment. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Exclusion criteria: 1. History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study treatment. Presence of pelvic lymph nodes 2. Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer. 3. Acute toxicities of prior treatments and procedures not resolved to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03 grade ââ?°Â¤ 1 or baseline before first dose of study treatment. 4. Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment. 5. Known hypersensitivity to the study treatment or any of its ingredients. 6. Major surgery within 28 days before first dose of study treatment. 7. 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 Association Class III or IV. 8. Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ââ?°Â¥ 160 mmHg or diastolic BP ââ?°Â¥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment. 9. End-stage renal disease (eGFR 10. 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 any other cancer for which treatment has been completed ââ?°Â¥ 5 years ago and from which the participant has been disease-free. 11. Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment. 12. Unstable active viral hepatitis with a need for treatment. 13. 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/Ã?¼L 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. 14. Any condition that, in the opinion of the investigator, would impair the participantsââ?¬• ability to comply with the study procedures or study treatment (e.g., unable to swallow study treatment). 15. Unwilling or unable to comply with all protocol-required visits and assessments or comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs and SAEs Incidence of discontinuations and dose modifications of study treatment due to AEs Laboratory, physical examination, and ECG abnormalities reported as AEs Changes in vital signs Changes in ECOG performance statusTimepoint: From the start of darolutamide treatment up to 30 days after the last dose of darolutamide. | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA percent change from baseline at 16 weeks PSA maximum percent decline from baseline at any time on study treatment Time to initiation of first subsequent antineoplastic therapy Time to initiation of first cytotoxic chemotherapy for prostate cancerTimepoint: All participants will visit the study center at Day 1, Week 16, and every 16 weeks thereafter. Participants will remain on study treatment until disease progression, death, consent withdrawal, lost to follow-up, or until any criteria for treatment withdrawal is met. At which time, an EoT visit will be performed 30 days after the last dose of study treatment. | — |
Countries
India
Contacts
Public ContactDr. Ashish Gawde
Bayer Pharmaceuticals Private Limited
Outcome results
None listed