ACTRN12623000216617尚未招募1 期
A pilot, feasibility study of 177Lu-DOTA-Rosopatamab (TLX591) therapy in castrate resistant prostate adenocarcinoma patients showing progression on radioligand therapy using PSMA small molecule ligands
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •To qualify for enrolment, patients must meet the following criteria:
- •1.Ability to understand and sign an approved Informed Consent Form (ICF).
- •2.Ability to understand and comply with all protocol requirements.
- •3.Males at least 18 years of age and older.
- •4.ECOG performance status of 0 to 2.
- •5.Life expectancy greater than 6 months.
- •6.Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
- •7.Have metastatic disease (at least 1 metastatic lesion present at baseline CT, MRI, or bone scan imaging).
- •8.Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy.
- •9.Patients must have progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC). Documented progressive mCRPC will be based on:
- •a.serum PSA progression defined as 2 consecutive increases in PSA from baseline of more than 25%, following a minimum of 2 cycles of radioligand therapy using PSMA small molecule ligands
- •b.appearance of two or more new lesions and/or increase of uptake or tumour PET volume greater than 30%
- •10.Have disease that is PSMA positive, as demonstrated by a 68Ga-PSMA PET/CT scan and without significant discordance at 18FDG PET/CT.
- •11.Must have recovered to at least Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, neoadjuvant androgen deprivation (NAAD), chemotherapy, etc.).
- •12.Can be receiving a bisphosphonate or denosumab regimen provided that the patient has been receiving and tolerating this treatment for at least 30 days prior to randomization.
- •13.Have adequate organ function at Screening, including bone marrow, liver and renal function.
- •a.Bone marrow: i. Platelets at least 150×109/L. ii. Absolute neutrophil count greater than 1.5×109/L. iii. Haemoglobin at least 10g/dL (no red blood cell transfusion in the previous 4 weeks).
- •b.Renal function: i. Serum/plasma creatinine less than 1.5×ULN or creatinine clearance equal to 50 mL/min determined using the Cockcroft & Gault formula.
- •c.Liver function: i. Total bilirubin less than 1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome less than 3×ULN is permitted. ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3×ULN OR less than 5×ULN for patients with liver metastases.
- •14.Patients must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the patient is or could be pregnant.
- •15.Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020).
排除标准
- •Exclusion Criteria:
- •1.Are unable to understand or are unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.
- •2.Uncontrolled pain.
- •3.Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease-free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, and superficial bladder cancer.
- •4.Are at increased risk of hemorrhage or bleeding, or with a recent history of a thrombotic event (e.g., deep vein thrombosis [DVT]/ pulmonary embolism [PE]) and have been administered long-term anti-coagulant or anti-platelet agents.
- •5.Have known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.
- •6.Have commenced any new systemic anti-cancer therapy since commencement of Lu-177-PSMA I&T therapy and recruitment or have any significant AE form previous therapy which have not resolved to National Cancer Institute (NCI) AE Criteria 2.
- •7.Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
- •8.Have received other investigational therapy within 4 weeks of treatment.
- •9.Previous Samarium, Strontium or Radium therapy.
- •10.Have a serious active or sub-clinical infection or heart failure (New York Heart Association [NYHA] Class III or IV), or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, which might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment.
- •11.Have received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.
研究者
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