ACTRN12623001072606尚未招募1 期
A phase 1a/b dose-escalation and dose-expansion study to evaluate Lutetium-177-PSMA I&T (Lu-PSMA) with radiosensitising Capecitabine in patients with metastatic castration-resistant prostate cancer (mCRPC)
South Metropolitan Health Service (SMHS)0 个研究点目标入组 45 人开始时间: 2023年10月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. At least 18 years of age.
- •2. Metastatic adenocarcinoma of the prostate defined by:
- •Documented histopathology of prostate adenocarcinoma (without any features of
- •neuroendocrine carcinoma) OR
- •A clinical diagnosis based on PSA elevation and typical imaging findings for
- •metastatic prostate cancer
- •3. Castration-resistant prostate cancer (defined as disease progressing despite castration
- •by orchiectomy or ongoing luteinising hormone-releasing hormone agonist or
- •antagonist).
- •4. Disease progression with rising PSA defined by PCWG3 criteria (sequence of 2 rising
- •values at a minimum of 1-week intervals).
- •5. Disease progression after at least one taxane chemotherapy in the mCRPC setting AND
- •at least one novel androgen receptor signalling inhibitor (in the setting of either mCSPC
- •or mCRPC). Patients with prostate cancer that has a known BRCA mutation must have
- •had at least one PARP inhibitor therapy. If BRCA status is unknown patients will be
- •eligible for inclusion.
- •6. Imaging evidence of metastatic disease documented with either bone scan or CT scan.
- •7. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as SUVmax >15 at a single
- •site (regardless of lesion size) and SUV max >10 at sites of disease = 10mm (unless
- •subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction
- •artefact) without FDG discordance. Metastases subject to these criteria are for soft
- •tissue disease (not bone metastases), and lymph node measurement taken from the
- •short axis.
- •8. ECOG performance status:
- •Dose-escalation phase: 0-2.
- •Dose-expansion phase: 0-1.
- •9. Adequate renal function:
- •Creatinine clearance greater than or equal to 40mL/ min (defined by either Cockcroft-Gault formula or by
- •nuclear medicine renal scan).
- •10. Adequate liver function:
- •Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5 - 2x ULN,
- •must have a normal conjugated bilirubin).
- •AST or ALT less than or equal to 2.0 x ULN (or less than or equal to 5.0 x ULN in the presence of liver metastases).
- •11. Adequate bone marrow function:
- •Platelets greater than or equal to 100 x109 /L.
- •Haemoglobin greater than or equal to 90g/L (no red blood cell transfusion in last 4 weeks).
- •Neutrophils > 1.5 x109 /L.
- •12. Estimated life expectancy > 12 weeks.
- •13. Study treatment both planned and able to start within 21 days of randomisation.
- •14. Willing and able to comply with all study requirements (including both treatments:
- •capecitabine and Lu-PSMA), and all required study assessments.
- •15. Signed, written, informed consent
排除标准
- •1. Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the prostate.
- •2. Site(s) of disease that are FDG-positive with minimal PSMA expression defined as FDG
- •intensity > 68Ga-PSMA activity OR 68Ga-PSMA SUVmax < 10
- •3. Prior treatment with any PSMA-targeted radiotherapy.
- •4. Presence of dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
- •5. History of another malignancy within 2 years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours); or other cancers that are unlikely to reoccur within 24 months.
- •6. Untreated brain metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A screening MRI brain is required for patients with a known history of brain metastases, and patient will meet exclusion criterion if disease progression evident. A baseline CT brain or MRI is only required if there is clinical suspicion of central nervous system involvement.
- •7. Concurrent illness, including severe infection that may jeopardise the ability of the
- •participant to undergo the procedures outlined in this protocol with reasonable safety.
- •8. Pre-existing G3+ toxicities not resolved to G2 or lower before day of randomisation.
- •9. Presence of any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule, including alcohol
- •dependence or drug abuse.
- •10. Men in sexual relationships with women of reproductive potential who are each not
- •willing/able to use medically acceptable forms of barrier contraception.
- •11. History of:
- •i. Significant cardiovascular disease within the last 3 months: including myocardial
- •infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 4.03), Chronic
- •stable atrial fibrillation is allowed.
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