NCT06866938招募中2 期
An Open Label, Single Arm Phase IIb Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 21
- 主要终点
- Progression-Free Survival rate
研究概览
简要总结
Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand [177Lu]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells.
The randomized phase III VISION study showed that [177Lu]Lu-PSMA-617 significantly improved progression-free survival and overall survival with an acceptable toxicity profile.
The ReaLuP study will evaluate the efficacy of a re-treatment of [177Lu]Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC and who have been previously treated with [177Lu]Lu-PSMA without evidence of progression during this first course of treatment.
Patients will be treated until disease progression, unacceptable toxicity or death, or alternatively up to 9 months after the last dose of treatment.
At the end of this follow up period, patients will enter the " long term follow up ", at least for 2 years after the end of the last active follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 assessed within 7 days of study treatment initiation
- •Histologically or cytologically confirmed adenocarcinoma of prostate (Patients with small cell carcinoma of the prostate may be included)
- •Metastatic disease documented by at least one lesion on bone scan or abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Patients without bone metastasis must have measurable lesions in extra-pelvic lymph nodes or in soft-tissues as defined by RECIST 1.1 criteria
- •Confirmed progression mCRPC despite ongoing androgen deprivation with serum testosterone < 50ng/dl (1.7nM) within 3 months prior to screening. Progression is defined by the presence of at least one of the following criteria :
- •PSA progression using local laboratory values as defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥1 ng/mL
- •Radiographic disease progression in bone based on PCWG3 criteria defined as the appearance of 2 or more new bone lesions on bone scan, with or without PSA progression
- •Radiographic disease progression in extra-pelvic lymph nodes based or soft-tissues on RECIST1.1 criteria with or without PSA progression
- •PSMA positive metastatic lesions on [68Ga]-PSMA-PET/CT without PSMA negative lesion (The presence of PSMA-positive lesions is defined as [68Ga]-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. The presence of PSMA-negative lesions is defined as PSMA uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA negative metastatic lesion meeting these criteria are ineligible).
- •Participants must have been previously treated with at least 4 consecutive cycles of [177Lu]Lu-PSMA with no evidence of progression during this first course of treatment (including radiological, clinical but also PSA progression).
- •Participants must have been previously treated with at least one ARSI - Androgen Receptor Signaling Inhibitors - (including enzalutamide, apalutamide, abiraterone or darolutamide) initiated for mCSPC, nmCRPC or mCRPC. (ARSI may be also administered together with [177Lu]Lu-PSMA-617 provided that the patient has not received an identical ARSI in the past and that this ARSI was initiated at least 15 days before the first cycle of [177Lu]Lu-PSMA-617 and less than 2 months ago. The ARSI administrated in association with LuPSMA should not be considered as a prior therapy. A previous ARSI treatment is mandatory for patient eligibility)
- •Patients must have been previously treated with at least one taxane based chemotherapy (with docetaxel or cabazitaxel) (The number of previously administrated lines of taxane-based therapy is not limited ; patients can have received a taxane-based chemotherapy before or after the first sequence of [177Lu]Lu-PSMA)
- •Patients must have been progressed at least 120 days after the last injection of the first course of [177Lu]Lu-PSMA therapy. (Patients with a radiological or clinical progressive disease during the first 120 days after the last cycle of the first course of [177Lu]Lu-PSMA are not eligible. PSA progression is defined by a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the NADIR and confirmed by a second consecutive value obtained 3 or more weeks later. Patients treated with chemotherapy, ARSI or PARP inhibitors between the first 117LuPSMA course and screening are also eligible).
- •Be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary medical cause) until 98 days (14 weeks) post-treatment.
- •Adequate organ functions :
- •Bone marrow reserve :
- •ANC ≥ 1.5 X 109/L
- •Platelets ≥ 100 X 109/L
- •Hemoglobin ≥ 10 g/dL
- •Hepatic :
- •Total bilirubin ≤ 2 x ULN. For patients with known Gilbert's syndrome ≤ 3 x ULN.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 x ULN
- •Clearance ≥40 ml/mn
- •Patients must have signed informed consent prior to participating in any study related procedures
- •Willing and able to comply with the protocol, including follow-up visits and examinations
- •Patients have to be affiliated to the French social security system, or equivalent
排除标准
- •History of a [177Lu]Lu-PSMA serious adverse event (SAE) or CTCAE Grade 3 or 4 AE during the initial course of [177Lu]Lu-PSMA that led to the discontinuation of treatment
- •More than one course of [177Lu]Lu-PSMA therapy
- •Less than 120 days from the last dose administrated in the initial course of [177Lu]Lu-PSMA treatment and the radiological or clinical disease progression, or the initiation of a subsequent therapy.
- •Any history of treatment with radium-223 dichloride or other systemic radiotherapy (including strontium-89, samarium-153, actinium-PSMA...)
- •Transfusion of red blood cells within 30 days prior to the first injection of the re-treatment of [177Lu]Lu-PSMA-617
- •Current central nervous system (CNS) metastases
- •Hypersensitivity to the active substance (Lutetium [177Lu] vipivotide tetraxetan or Gallium [68Ga] gozetotide) or to any of the excipients
- •Prior > hemibody external radiotherapy
- •Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
- •Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- •Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
- •Ongoing participation in any other clinical trial who may interfere with the present study in the judgment of the investigator
- •Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
- •Active clinically significant cardiac disease
- •History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
- •Patients under tutorship or guardianship
研究组 & 干预措施
[177Lu]Lu-PSMA-617
Experimental
Patients with metastatic castration resistance prostate cancer will be treated with intravenous [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) at the dose of 7.4 GBq (±10%) every 6 weeks Treatment duration: 4 to 6 cycles (24 to 36 weeks)
干预措施: [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) (Drug)
结局指标
主要结局
Progression-Free Survival rate
时间窗: At 24 weeks after the start of study treatment
Proportion (in %) of patients alive without disease progression at 24 weeks. Progression is defined by imaging (bone scan and CT-scan) according to RECIST 1.1 and/or PCWG3 criteria.
次要结局
- Imaging-based radiographic progression (rPFS)(Through study completion, a maximum of 57 months)
- Overall survival(Through study completion, a maximum of 57 months)
- Objective response rate(Through study completion, a maximum of 57 months)
- Duration of response(Through study completion, a maximum of 57 months)
- Disease Control Rate(Through study completion, a maximum of 57 months)
- Progression free survival(Through study completion, a maximum of 57 months)
- Biological response(Through study completion, a maximum of 57 months)
- Time to PSA progression(Through study completion, a maximum of 57 months)
- Safety : Adverse Events(Through study completion, a maximum of 57 months)
- Pain assessment(Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration)
- Symptomatic Skeletal Event (SSE) assessment(Through study completion, a maximum of 57 months)
- Quality of life assessment(Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration)
研究者
研究点 (21)
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