NL-OMON56330招募中2 期
Phase II randomised controlled trial of patient-specific adaptive versus continuous Abiraterone or eNZalutamide in metastatic castration-resistant prostate cancer: the ANZadapt study - the ANZadapt study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
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
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Willing and able to provide informed consent;
- •2. Aged 18 or older;
- •3. Histologically or cytologically confirmed adenocarcinoma of the prostate;
- •4. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral
- •orchiectomy (i.e. surgical or medical castration with testosterone at screening
- •<=1.7 nmol/L (<0.5 ng/mL)); patients who have not had a bilateral orchiectomy,
- •must have a plan to maintain effective GnRH-analogue therapy for the duration
- •of the trial;
- •5. Presence of metastatic disease on WBBS and/or CT-scan;
- •6. Progressive disease at study entry defined as per PCWG3 as one or more of
- •the following criteria that occurred while the patient was on ADT:
- •a. PSA progression defined by a minimum of 2 rising PSA levels with an interval
- •of >=1 week between each determination. Patients who received an anti-androgen
- •must have PSA progression after withdrawal (>=4 6 weeks since last cyproterone,
- •flutamide, or >=6 weeks since last bicalutamide or nilutamide); OR
- •b. Radiographic PD on bone scintigraphy and/or CT-scan;
- •7. A PSA concentration of >=10 ng/mL.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •9. Controlled symptoms (opioids for cancer related pain stable for >4 weeks, no
- •need for urgent radiotherapy for symptomatic lesions);
- •10. Estimated life expectancy of >=12 months;
- •11. Patient has archival prostate cancer tissue available and which he consents
- •to share or is willing to undergo a new tumour biopsy;
- •12. Adequate organ function: absolute neutrophil count >1,500/µL (>1.5*109/L);
- •platelet count >100,000/µL (>100*109 /L), haemoglobin >90 g/L (>5.6 mmol/L);
- •total bilirubin <1.5 times ULN, alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) <2.5 times ULN; creatinine <175 µmol/L; albumin >30 g/L;
- •13. Any other therapies for CRPC (excluding denosumab and bisphosphonates) have
- •to be discontinued 3 weeks prior to study randomisation;
- •14. Able to swallow the study drug and comply with study requirements.
排除标准
- •1. Life-threatening or serious medical or psychiatric illness that could, in
- •investigator's opinion, potentially interfere with participation in this study;
- •2. Diagnosis or treatment for another systemic malignancy within 2 years before
- •the first dose of study drugs. Potential participants with non-melanoma skin
- •cancer, non-muscle invasive bladder cancer, or carcinoma in situ of any type
- •are allowed if they have undergone complete resection;
- •3. Known or suspected brain metastasis or leptomeningeal disease;
- •4. Small-cell or neuroendocrine differentiation of prostate cancer;
- •5. Radiation therapy for treatment of the primary tumour within 3 weeks of
- •screening visit;
- •6. Radiation or radionuclide therapy for treatment of metastasis within 3 weeks
- •of screening visit, excluding radiation to reduce pain symptoms;
- •7. History of uncontrolled seizures (if patient and investigator wish to choose
- •treatment with enzalutamide)
- •8. Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York
- •Heart Association (NYHA) Class III or IV heart failure;
- •9. Known HIV infection, active chronic hepatitis B or C;
- •10. Known gastrointestinal (GI) disease that could interfere with GI
- •absorption/tolerance of study drugs;
- •11. Prior treatments with CYP17 inhibitors (e.g. ketoconazole) or novel
- •androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or
- •enzalutamide). Bicalutamide, flutamide, cyproterone and nilutamide should be
- •stopped >6 weeks before screening visit. Prior treatment with docetaxel in the
- •mHSPC setting is allowed.
- •12. Any condition or reason that, in the opinion of the Investigator,
- •interferes with the ability of the patient to participate in the trial, which
- •places the patient at undue risk, or complicates the interpretation of safety
研究者
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