NCT06907641已完成2 期
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
St Vincent's Hospital, Sydney2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
研究概览
简要总结
The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:
- Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
- What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
- Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Participants will:
- have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
- have standard of care blood test either at Visit 1 or Visit 2
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
- •Male patients aged 18 or above
- •Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
- •Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
- •Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
- •68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.
排除标准
- •Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
- •History of current active malignancy as per investigator discretion other than prostate cancer.
- •Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
- •Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.
研究组 & 干预措施
64Cu-SAR-bisPSMA
Experimental
200MBq 64Cu-SAR-bisPSMA
干预措施: 64Cu-SAR-bisPSMA (Drug)
结局指标
主要结局
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
时间窗: 12 months
Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.
次要结局
- Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.(12 months)
- Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints.(12 months)
- Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth(12 months)
- Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).(12 months)
- Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images(12 months)
- Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels.(12 months)
研究者
Louise Emmett
Professor
St Vincent's Hospital, Sydney
研究点 (2)
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