ACTRN12618000665235进行中（未招募）2 期
A prospective, intra-individual, blinded, comparison of the diagnostic accuracy of 18F-PSMA-1007 and 68Ga-PSMA-11 imaging in patients with confirmed prostate cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- Male
入选标准
- •All patients:
- •1. Age equal to or greater than 60 years.
- •2. Patient has provided written informed consent for participation in this trial
- •3. The patient is able to comply with the required study procedures
- •Primary staging cohort:
- •1. Newly-diagnosed, untreated, biopsy proven adenocarcinoma of the prostate gland.
- •2. Patients must have at least one of the following features
- •- Gleason group 3, 4 or 5
- •- PSA >20 ng/mL within 12 weeks prior to referral
- •- Clinical stage =T3
- •Biochemical recurrence restaging cohort:
- •A. Prostatectomy cohort
- •1. Complete excision of the prostate gland, R0- or R1- resection
- •2. PSA =0.2ng/mL after nadir following radical prostatectomy
- •B. Radiotherapy cohort
- •1. Organ-preserving local treatment (external beam radiation therapy, brachytherapy, seed implantation, high intensity focused ultrasound)
- •2. PSA increase of 2.0ng/mL greater than the lowest recorded PSA value following therapy
- •Known metastatic disease restaging cohort:
- •1. Known distant metastatic prostate cancer (M1 a/b/c) diagnosed by at least one of the following:
- •- 68Ga-PSMA-11 demonstrating metastatic disease
- •- WBBS demonstrating lesions characteristic of prostate cancer metastases
- •- CT or MRI imaging demonstrating lesions characteristic of prostate cancer metastases
- •- Histological confirmation of prostate cancer metastasis
排除标准
- •1. Significant intercurrent comorbidity that, in the opinion of the investigators, would limit compliance with the study protocol
- •2. Change in prostate cancer therapy after the 68Ga-PSMA-11 PET/CT but before the 18F-PSMA-1007 PET/CT.
研究者
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