68Ga-PSMA, N,N'-Bis(2-hydroxybenzyl)Ethylenediamine-N,N'-Diacetic Acid (HBED)-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,230
- 试验地点
- 1
- 主要终点
- the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
研究概览
简要总结
Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.
详细描述
Single-center, prospective, diagnostic trial. The primary objective of this study is to evaluate the sensitivity of 68Ga-PSMA PET /CT defined as the ratio between the number of 68Ga-PSMA PET /CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.
The secondary objectives are:
- Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges)
- Sensitivity for different lesion sites
- Treatment response assessment with a second PET
- False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment
- safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed prostate cancer
- •Male, aged >18 years.
- •Radical treatment for prostate cancer (radiotherapy or surgery)
- •18F-FMC PET/CT negative or doubtful
- •Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
- •Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
- •Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •No hormonotherapy in the last 6 months
- •No radiotherapy in the last 6 months.
- •Patients with PSA < 1.0 ng/ml
- •Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- •Medical or psychological conditions that would not permit the subject to complete to sign informed consent
研究组 & 干预措施
68Ga- PSMA PET/CT
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
干预措施: 68Ga- PSMA (Drug)
结局指标
主要结局
the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
时间窗: up to 24 months
the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
次要结局
- Sensitivity for different PSA values (ranges)(up to 24 months)
- Sensitivity for different lesion sites(up to 24 months)
- PSA decrease: the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity. Youden's index will be used for determining cut-off value between pos and neg 68Ga-PSMA PET/CT findings(up to 24 months)
- Evaluation of the concordance between 68Ga- PSMA PET/CT and PET/CT or the others standard methods, performed by the Cohen's kappa coefficient.(up to 24 months)
- number of treated patients experiencing grade 1 to 4 adverse events(up to 24 months)
- percentage of treated patients experiencing grade 1 to 4 adverse events(up to 24 months)