18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 1
- 主要终点
- Safety - immediate
研究概览
简要总结
A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
- Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:
- The participant will be screened for adverse effects immediately post-injection
- The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
- The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)
The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:
- All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
- The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
- Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021)
- Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy
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
- •Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- •Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- •Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- •Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
排除标准
- •Unable to obtain consent
- •Weight > 225 kg (weight limit of PET/CT scanners)
- •Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- •Lack of intravenous access
- •History of allergic reaction to 18F-PSMA-1007
- •Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
- •Less than 18 years old
- •NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation
研究组 & 干预措施
18F-PSMA-1007
18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose
干预措施: 18F-PSMA-1007 (Drug)
结局指标
主要结局
Safety - immediate
时间窗: Immediately after tracer injection
The participant will be screened for adverse effects immediately post-injection
Safety - post scan
时间窗: 2.5 hours after tracer injection
The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection).
Safety - delayed
时间窗: 1-7 days after tracer injection
The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection)
Non-specific bone lesion assessment (NSBLs)
时间窗: 1 year after tracer injection
SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection
次要结局
未报告次要终点