A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up.
研究概览
简要总结
This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Are able to understand and provide written informed consent document.
- •Are Chinese males aged ≥ 18 years.
- •Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).
- •Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
- •Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
- •Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
- •Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
- •Are willing and able to comply with scheduled
排除标准
- •Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- •Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-
- •Are participating or plan to participate in any drug or device clinical study during the study period.
- •Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-
- •Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
- •Have prior history of salivary gland disease or Paget's disease.
- •Have a history of fracture and anemia within the last year.
- •Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
- •Is deemed not suitable for participating in this trial in the opinion of the investigator.
研究组 & 干预措施
Treatment (68Ga-PSMA-11)
111 ~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes.
After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.
干预措施: 68Ga-PSMA-11 (Drug)
Treatment (68Ga-PSMA-11)
111 ~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes.
After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.
干预措施: PET/CT or PET/MRI (Other)
结局指标
主要结局
Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up.
时间窗: 12 months
The PPV \[PPV (%) = TP\* /(TP + FP\*\*)\] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative).
次要结局
- Clinical management in biochemical recurrence patients.(3 days)
- Incidence of adverse events(3 days)