PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Determination of the optimal scan protocol: define optimal time of scanning
研究概览
简要总结
Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Original phase 2 trial (44 subjects)
The assigned [18F]PSMA-11 dosing group will be blind to the recruiting physicians, the patient the staff member(s) while planning the [18F]PSMA-11 scanday of the patient, and the nuclear medicine physicians interpreting the images.
Next to the clinical trial coordinators, also the staff members responsible for the preparation of the individual [18F]PSMA-11 dose and the IV injection of this dose are aware of the dose group (2.0 ± 0.2 or 4.0 ± 0.4 MBq/kg body weight), which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings.
Extension phase 2 trial (22 subjects):
masking is not applicable for this part of the phase 2 trial.
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
- •Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.
排除标准
- •Age: <18 years
- •Physically or mentally unfit to perform the sequential procedures
- •Refusal of patient to be informed about accidental findings on scans
- •Patients with heart failure if ejection fraction < 45% (phase 2 trial)
- •History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)
研究组 & 干预措施
4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
Concerning the dose of [18F]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm
干预措施: [18F]PSMA-11 (Diagnostic Test)
2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
To define the optimal [18F]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg.
Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm.
As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference.
干预措施: [18F]PSMA-11 (Diagnostic Test)
结局指标
主要结局
Determination of the optimal scan protocol: define optimal time of scanning
时间窗: 0 to 3.5 hours post radiotracer injection
Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale - higher score represents a higher intensity lesion), the optimal time (60 min or 180 min post radiotracer injection) will be defined
Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol
时间窗: 0 to 1.5 hours post radiotracer injection
Based on the degree that the radiotracer uptake in the bladder and in the ureters is disruptive for the interpretation of the scan (visual interpretation by nuclearist using a 7 point '1-7' scoring scale, higher score equals a more pronounced disturbance), the added value of furosemide, as part of the standard scanprotocol, will be defined
Determination of the optimal scan protocol: define optimal scan duration
时间窗: 0 to 3.5 hours post radiotracer injection
Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale, higher score represents a higher intensity lesion), the optimal scan duration (1.5 minutes/bed position or 3.0 minutes/bed position) will be defined
Evaluation of effective targeting of prostate cancer and eventual metastases
时间窗: 0 to 3.5 hours post radiotracer injection
Two PET/CT scans with \[18F\]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases
Determination of the optimal scan protocol: define optimal dose
时间窗: 0 to 3.5 hours post radiotracer injection
Based on the overall image quality (7 point '1-7' scoring scale for image blurriness, higher score represents a higher quality image), the optimal dose of \[18F\]PSMA-11 (2.0 or 4.0 MBq/kg) will be defined
次要结局
- Evaluation of the diagnostic specificity of [18F]PSMA-11(0 - 60 days post [18F]PSMA-11 administration)
- Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans(0 - 60 days post [18F]PSMA-11 administration)
- Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy(Pre [18F]PSMA-11 PET management plan: between the date the patient signed the informed consent form and the date of the [18F]PSMA-11 scan. Post [18F]PSMA-11 PET management plan: 0 - 60 days post [18F]PSMA-11 administration)