2024-519346-75-00招募中2 期
Radiometabolic Therapy (RMT) with 177Lu PSMA in PSMA PET/CT positive advanced/metastatic tumours: a basket trial (LUBASKET)
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2025年1月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1), or no progression of disease for patients with prostate cancer (according to PCWG3 criteria), at the 1st planned evaluation. Safety, evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle.
研究概览
简要总结
The main objective of this phase II study is to evaluate the disease control rate (DCR) and safety as co-primary objective in different histologies.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed advanced/metastatic solid tumors; any other tumor types documented as PSMA-positive that may benefit from receptor radionuclide therapy and for which there aren't any other effective treatments. For cerebral PSMA-positive tumors, if biopsy is no feasible for technical reasons or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 18F- and/or 68Ga PET-CT PSMA positivity;
- •patients must have normal organ and marrow function as defined below: leukocytes >= 3,000/µL; absolute neutrophil count >= 1,500/µL; hemoglobin >= 9 g/dL; platelets >= 100,000/µL; total bilirubin <= 1.5 X institutional upper normal limit (this will not apply to patients with confirmed Gilbert’s syndrome); AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper normal limit (< 5 X UNL in presence of liver metastases); creatinine <= 2 mg/dL
- •A female participant is eligible to participate if she is not pregnant and not breastfeeding;
- •Participant is willing and able to give informed consent for participation in the study.
- •patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled;
- •relapse or progression of disease on CT/MRI scan and/or WBD-MRI;
- •for patients with prostate cancer: documented radiological progression (in soft tissue and / or bone) and/or biochemical progression (sequence of PSA rising values from a minimal starting value g >=1 ng/ml) according to PCWG3;
- •patients will be admitted to therapeutic phase only if the diagnostic PET/CT PSMA SUV max is >= g 3;
- •no therapeutic alternatives
- •male or Female, aged >= 18 years
- •life expectancy of greater than 12 weeks
- •ECOG performance status <= 2
排除标准
- •patients who have completed chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and hormonotherapy within 2 weeks (excluding mCRPC patients), prior to treatment start. A window of 3 days is permitted;
- •all acute toxic effects of any prior therapy (including surgery, radiation therapy, and chemotherapy) must have resolved to a grade f 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE);
- •participation in another clinical trial with any investigational agents within 30 days prior to study treatment start. A window of 3 days is permitted;
- •history of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMAs or other agents used in the study
- •medical or psychological conditions that would not allow the participant to understand, or sign the informed consent;
- •uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
结局指标
主要结局
DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1), or no progression of disease for patients with prostate cancer (according to PCWG3 criteria), at the 1st planned evaluation. Safety, evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle.
DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1), or no progression of disease for patients with prostate cancer (according to PCWG3 criteria), at the 1st planned evaluation. Safety, evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle.
次要结局
- PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression (according to RECIST 1.1 or PCWG3 criteria for prostate cancer patients) or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
- Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
- The late toxicity is the toxicity that occurred after 30 days from the last treatment administration up to 6 months.
- PET/CT response is based on SUV. The dosimetry objective is evaluated through pharmacokinetic measures, biodistribution activity and absorbed dose to salivary gland (critical organ), kidneys, bone marrow and tumour.
研究者
Maddalena Sansovini
Scientific
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluatioadvanced castration resistant prostate cancer (CRPC)MedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 100000004864EUCTR2016-002732-32-ITISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS210
已完成
1 期
Radionuclide therapy using 177Lu-PSMA: a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)castrate-resistant prostate cancerACTRN12618001552279St Vincent's Hospital15
进行中（未招募）
2 期
Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:CancerNCT05867615Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS83
招募中
2 期
177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment with locoregional teleradiotherapy and hormone therapy.Prostate Cancer2023-504912-13-00Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy200
招募中
2 期
Study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs and PPGLs.2023-507444-37-00Advanced Accelerator Applications5