CTRI/2022/03/041422招募中4 期
A single-arm, open-label Phase 4 study ofdarolutamide in addition to standard androgendeprivation therapy for participants in India with highrisknon-metastatic castration-resistant prostate cancer(nmCRPC)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 = 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 ( < 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 orchiectomy must
- •continue GnRH therapy during the study.
- •6. PSADT of = 10 months and PSA = 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 = 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 within 7 days of the
- •hematology laboratory obtained at screening).
- •10. Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase
- •(AST) = 2.5 × upper limit of normal (ULN), total bilirubin = 1.5 × ULN (except
- •participants with a diagnosis of Gilbert’s disease), creatinine = 2.0 × 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 <1% per year, and refrain from sperm
- •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.
排除标准
- •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 < 1.5 cm in short axis below the aortic bifurcation is allowed.
- •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 = 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) = 160 mmHg
- •or diastolic BP = 100 mmHg at screening despite medical management. Participants
- •with hypertension can enroll provided BP is stable and controlled by anti-hypertensive
- •9. End-stage renal disease (eGFR < 15 mL/min/1.73 m2).
- •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 = 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/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.
- •14. 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).
- •15. Unwilling or unable to comply with all protocol-required visits and assessments or
- •comply with study requirements.
研究者
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