PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 6
- 主要终点
- number of PSMA-avid lesions (count)
研究概览
简要总结
This prospective clinical study aims to evaluate the predictive power of PSMA PET imaging in patients with advanced prostate cancer who are receiving systemic drug therapies.
The primary goal is to identify prognostic factors derived from PSMA PET imaging. These factors include the number of cancer lesions, the size of the tumor, and measurements known as SUVmax and SUVmean. By identifying these factors, the investigators aim to better group patients and predict those who may have a less favorable outcome. While PSMA PET imaging is highly accurate in locating cancer sites within the body, its ability to predict treatment response has not yet been thoroughly studied in a prospective manner for this patient population.
This study will assess the predictive role of PSMA PET imaging and its ability to forecast treatment response across a range of systemic therapies, including hormone therapy and chemotherapy, in patients with both hormone-sensitive (HSPC) and castration-resistant (CRPC) prostate cancer.
详细描述
Purpose: to determine the prognostic value of PSMA PET imaging in patients diagnosed with advanced prostate cancer who are undergoing systemic therapies. The study will enroll patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) disease.
Design of the register: observational, pharmacological, non-profit, prospective, multicentric.
Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 9 years.
The primary objective is to evaluate the predictive capacity of PSMA PET, focusing on quantitative parameters such as the number of lesions, tumor volume (as assessed by metabolic tumor volume - MTV), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean), to stratify patient risk and predict unfavorable clinical outcomes (e.g., progression-free survival, overall survival).
This research will address the existing knowledge gap regarding the predictive ability of PSMA PET beyond its established role in disease localization. Specifically, the study will investigate if PSMA PET parameters can forecast response to a spectrum of systemic treatments, including but not limited to: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, and 225-actinium PSMA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);
- •Patients undergoing PSMA PET for pre-treatment disease staging;
- •Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;
- •Provision of signed informed consent for study participation and data handling.
排除标准
- •Inability to remain supine and still for the PET/CT image acquisition;
- •Prostate cancer with a known significant neuroendocrine component;
- •Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.
研究组 & 干预措施
PELICAN population
Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer
干预措施: PSMA PET/CT scan (Radiation)
结局指标
主要结局
number of PSMA-avid lesions (count)
时间窗: From baseline PET/CT through study completion, an average of 2 years
number of PSMA-avid lesions (count)
metabolic tumor volume (MTV in cm 3)
时间窗: From baseline PET/CT through study completion, an average of 2 years
metabolic tumor volume (MTV in cm 3)
maximum standardized uptake value (SUVmax, dimensionless)
时间窗: From baseline PET/CT through study completion, an average of 2 years
maximum standardized uptake value (SUVmax, dimensionless)
mean standardized uptake value (SUVmean, dimensionless)
时间窗: From baseline PET/CT through study completion, an average of 2 years
mean standardized uptake value (SUVmean, dimensionless)
次要结局
- Prediction of Treatment Response via PSMA PET(From baseline PET/CT through study completion, an average of 2 years)
- Comparative Analysis of Imaging Modalities(From baseline PET/CT through study completion, an average of 2 years)
- Assessment of Tumor Volume Dynamics(From baseline PET/CT through study completion, an average of 2 years)
研究者
Andrea Farolfi
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna