PRISMA-PET - Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 385
- 试验地点
- 5
- 主要终点
- Progression Free Survival (Group A vs. B)
研究概览
简要总结
Early and correct diagnostic staging is paramount to keep patients with newly diagnosed prostate cancer in the correct treatment tract to avoid under- and overdiagnosis in prostate cancer staging. With accurate staging, the investigators aim to save patients from side effects of insufficient or too extensive treatment. The investigators hypothesize that precise staging will lead to optimized individualized treatment and subsequently to prolonged survival and increased quality of life.
Prostate cancer is a very heterogeneous disease varying from indolent tumors to aggressive cancer types. About one-fifth of patients with newly detected high- or intermediate-risk prostate cancer present with bone metastases and their 3-years survival is less than 50%. Precise staging is required for planning relevant treatment that has the potential to increase survival.
The prostate-specific membrane antigen (PSMA) is overexpressed in prostate cancer cells and can serve as a target for precise diagnosis and staging. PSMA-positron emission tomography/computed tomography (PET/CT) has shown to be more accurate than traditional imaging, but there is a need for prospective trials analyzing the impact of primary staging with PSMA-PET/CT on treatment planning and patient benefit.
In a prospective multicenter study, the investigators plan to include 448 patients and randomize 1:1 to either traditional imaging or PSMA-PET/CT. The investigators aim to analyze whether PSMA-PET/CT increases progression-free survival and quality of life. Further, the investigators aim to validate the accuracy of primary staging with PSMA-PET/CT compared with conventional imaging.
详细描述
Introduction
The proposed project shall reveal whether primary staging with up-to-date imaging benefits prostate cancer (PCa) patients in terms of yielding prolonged progression-free survival and increased quality of life (QoL).
The study is planned in a collaborative effort between five centers in the Region of Southern Denmark and the Central Denmark Region. The Department of Nuclear Medicine at Odense University Hospital is the hosting department.
A prospective multicenter randomized design is planned. We expect to include 448 patients with newly diagnosed PCa of high or intermediate risk. Eligible patients will be randomized 1:1 into an interventional arm using PSMA-PET/CT and a control arm using conventional imaging. In a relevant subgroup, the investigators will also analyze the added value of performing PSMA-PET/magnetic resonance imaging (MRi).
The investigators hypothesize that PSMA-PET/CT will lead to prolonged progression-free survival and increased quality of life when used for staging patients with intermediate and high-risk primary prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Has given informed consent to participate
- •Can read and understand provided patient information material in Danish
- •Biopsy verified PCa
- •Any, some, or all of the following features:
- •Prostatic Specific Antigen (PSA) ≥ 20 ng/ml OR
- •Gleason Score ≥ 4+3 OR
- •Tumor stage clinically judged T2c cancer (cT2c) or above as determined by digital rectal exploration and/or transrectal ultrasonography
- •Suspicion of metastases clinically based on other findings
- •Prostatic Specific Antigen (PSA) ≤ 200 ng/ml
- •Staging by imaging warranted
排除标准
- •Consent not given
- •Inability to read and/or understand provided patient information in Danish
- •Previously given consent but withdrawn for any reason
- •Staging by imaging not warranted as judged clinically
- •Allergy towards contents in the tracer solution
结局指标
主要结局
Progression Free Survival (Group A vs. B)
时间窗: 1 to 3 years after staging
Time from treatment with curative intent to progression, eg. time from staging/curative treatment to PSA-value (or other clinical findings) deeming relapse.
次要结局
- Treatment Strategy (Group A vs. B)(Immediately after staging - 1-2 months after the scan.)
- Quality of life according to questionnaires (Group A vs. B)(1 to 3 years after staging. Questionnaire: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P v. 4))
研究者
Karen Middelbo Buch-Olsen
physician, Principal Investigator
Odense University Hospital