177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiographic progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan.
Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.
The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.
The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.
This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
详细描述
This clinical study investigates the safety and effectiveness of the FDA-approved drug Pluvicto (Lu-177-PSMA617).
It focuses on a unique group of patients with metastatic castration-resistant prostate cancer (mCRPC) who present with a "super scan" on bone scintigraphy-a pattern indicating widespread cancer in the bones.
These patients were excluded from prior trials like the VISION study, leaving a critical gap in clinical understanding.
The trial aims to identify the optimal safe dose of Pluvicto using a modified 3+3 dose-escalation method, beginning at a low dose that increases, and eventually reaching up to 200 mCi.
Participants will receive a total of six doses, spaced every 6 ± 1 weeks. Primary objectives include determining the maximum tolerated dose and monitoring safety using CTCAE version 5.0 criteria.
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
- •Ability to understand and sign an informed consent form (ICF).
- •Willingness and ability to comply with study requirements.
- •Age ≥18 years.
- •Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Hemoglobin ≥9.0 g/dL.
- •Platelet count ≥90 × 10⁹/L.
- •White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) >1.5 × 10⁹/L.
- •o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).
- •Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
- •Histological, pathological, or cytological confirmation of prostate cancer.
- •Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
- •Castrate-level serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
- •Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).
排除标准
- •Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
- •Prior PSMA-targeted radioligand therapy.
- •Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
- •Known hypersensitivity to PLUVICTO or its components.
- •Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- •Renal impairment (estimated glomerular filtration rate <60 mL/min), hemoglobin <9 g/dL, ANC <1.5 × 10⁹/L, or platelets < 90 × 10⁹/L.
- •History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
- •Symptomatic or impending spinal cord compression.
- •Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.
- •Major surgery within 30 days prior to enrollment.
- •Plans to conceive or father a child during treatment and up to six months post-treatment.
研究组 & 干预措施
Treatment Arm
干预措施: Administering Lutetium-177-PSMA-617 (PLUVICTO) (Drug)
结局指标
主要结局
Radiographic progression-free survival
时间窗: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.
Overall Survival
时间窗: From date of enrollment until the date of death from any cause, assessed up to 24 months.
OS: Defined as the time from enrollment to death from any cause.
次要结局
未报告次要终点
研究者
Ebrahim S Delpassand
Chairman & Medical Director, Excel Diagnostics & Nuclear Oncology Center
Excel Diagnostics and Nuclear Oncology Center