A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The aim of this study is to assess the safety and dosimetry of imaging with [68Ga]Ga-OncoACP3 in patients with prostate cancer.
详细描述
This is a phase I, non-randomized, open-label, multicenter clinical trial to evaluate primary the safety and dosimetry of a single dose of [68Ga]Ga-OncoACP3 and, secondly, its uptake, biodistribution, PK and excretion.
The Acid Phosphatase 3 (ACP3) is expressed in primary and metastatic prostate cancer lesions. OncoACP3 is a new ligand for ACP3: its radiolabelled version can be used as a PET radiotracer for the diagnostic imaging of prostate cancer. In this trial, 68Ga-OncoACP3 is offered to prostate cancer patients who already received standard of care imaging and might therefore complement available modalities.
Eligible patients for this trial are prostate cancer patients, aged 18 years or more with:
- suspected metastasis who are candidates for initial definitive therapy
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
- metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands.
All patients will undergo PET/CT imaging with [68Ga]Ga-OncoACP3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Prostate cancer patients with:
- •suspected metastasis who are candidates for initial definitive therapy
- •suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
- •metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)
- •Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
- •Patient must not have any concomitant infections or active concomitant disease.
- •All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤
- •Life expectancy of more than 12 weeks.
- •Ability to undergo imaging study procedures.
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.
排除标准
- •Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine
- •Presence of active hepatitis.
- •Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
- •Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- •Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Allergy to study medication or excipients in study medication.
- •Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoACP3-PET/CT scan.
- •Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before [68Ga]Ga-OncoACP3 injection to end of study participation.
研究组 & 干预措施
Cohort B
All patients who meet the eligibility criteria (up to 15 patients).
干预措施: [68Ga]Ga-OncoACP3 (Drug)
Cohort A
5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
干预措施: [68Ga]Ga-OncoACP3 (Drug)
结局指标
主要结局
Adverse events (AEs) and Serious Adverse Events (SAEs)
时间窗: Throughout study, until a maximum of 7 days after the administration of the study drug.
Adverse events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.6.0.
Effective dose equivalent (mSv) and absorbed doses (mGy)
时间窗: Assessed on day 1
Effective dose equivalent (mSv) and absorbed doses (mGy) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoACP3.
次要结局
未报告次要终点